Post on 18-Jan-2020
Prepared by Salwa Ibrahim Supervised by Dr Ola Anabtawi
MEDINA
(Mediterranean Dietary Intervention
study in Non-alcoholic fatty liver disease)
1
bull INTRODUCTION
bull METHODS
bull RESULT
bull DISCUSSION
bull Recommendation
2
3
Non-alcoholic fatty liver disease (NAFLD) and its progressive form non-alcoholic steatohepatitis (NASH) are among the most prevalent of liver diseases worldwide
Approximately 20 to 30 of the adult population has NAFLD making it the most common liver disease in developed countries
The incidence is as high as 50ndash85 in people with pre-diabetes and diabetes
Diet is a modifiable risk factor that can potentially be targetedin both the prevention and treatment of NAFLD
4
Hepatocellular carcinoma
Lead to cirrhosis and its
complication include
portal hypertensive
bleeding
Hepatic decompensation
NAFLD
5
1bull demonstrated a significant improvement in insulin sensitivity and
hepatic steatosis with the MedDiet compared to the low fat diet group
2
bull aims to replicate the findings of Ryan et alrsquos pilot study in alarger cohort of participants with NAFLD in a more translatable environment and with assessment of sustainability
3bull aims to investigate the effects of adhering to the MedDiet as compared
to a low fat diet
Pilot data to support the shift from current dietary therapy to a novel MedDietintervention of patients with NAFLD has been published by Ryan et al in NAFLD patients This study
6
lower incidence of chronic disease
including CVD
Obesity
Dementia
Some cancers
Overall mortalityAnd keep you young nourish your body
7
12 week multi-centre
parallel randomisedcontrolled trial of a Med Diet versus a Low Fat Diet (LFD)
8
Are Non-English speaking
Consume on average gt140 gweek of alcohol (men and women)
Are taking the following medicationsimmunosuppressants amiodarone andor perhexiline
Have a HbA1c score exceeding 8
Have clinically relevant pulmonary gastro-intestinal renal metabolic hematological neurological
Are women who are pregnant
Have psychosocial or gastrointestinal (eg malabsorptiveconditions eg coeliac)
Age gt18 years
(BMI) between 20 and 399 kgm2
diagnosis of NAFLD determined
by routine ultrasound or biopsy
insulin resistance based on a HOMA IR score of gt2 and at least one elevated
serum ALT level (gt20 UL female gt30 UL male) during the past 6 months
9
10
The intervention is based on
11
LOW FAT DIETMEDITERRANEAN FOOD PYRAMID VS
12
All participants will be provided with written resources specifically designed to explain the and how it can be successfully followed and adhered to These resourcestMedDie
include
A food pyramid
healthy eating guidelines and tips
meal plans
recipes in the form of The Mediterranean Diet
a shopping list label reading
Participants will also be supplied with extra virgin olive oil
nuts
canned legumes
Fish
Breakfast is also provided on the day of all face to face appointments
13
Low fat diet
The LFD group will follow the same structure as theMedDiet arm with three face to face consultations atbaseline 6 weeks (mid intervention) and 12 weeks (endof intervention)
There will also be the same number of phone call follow ups at weeks 2 4 and 9
Participants will also be given a supermarket gift voucher to purchase some of the suggested food items
Breakfast is also provided on the day of all face to faceappointments
14
patients in the MedDiet
had significant improvements in insulin sensitivity as determinedby a 3-hour hyperinsulinaemic-euglycaemic clamp
significant reduction (39 ) in hepatic steatosis
low fat Diet
no significant improvement in insulin sensitivity and only a 7 reduction of hepatic steatosis with the low fat high carbohydrate diet
The changes observed in the intervention group were without a significantreduction in weight
15
The MedDiet has positive effects on insulin sensitivity which has been attributed to
the high content of bio-active phytochemicals with a range of antioxidant and anti-inflammatory activity
The MedDiet is characterised by a specific fatty acid profile low in saturated fat (7ndash8 of total energy) and high in monounsaturated fat(20 of total energy)
16
Although environmental influences such as diet have awell-established association with disease it is important to acknowledge that the interplay of genetics and environment are a widely accepted influence in disease outcomes
Currently there are no safe or effective proven therapiesfor the treatment of patients with NAFLD or NASH While diet and lifestyle changes focussing on achievingweight loss are the accepted recommendations for this patientGroupEnjoy your food eat whatrsquos good for you in moderation and remember the words of
ldquoLet food be the medicine and medicine be the foodrdquo
17
controlled trial of randomisedA ) 2016J( AmandaStuart KElena Sa Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA) study
3-0426-016-12876s118610)pp 14(16protocol
httpwwwdietplan-101commediterranean-diet-meal-planning-things-to-keep-in-mind
18
Thank you for your attention
Any questions
bull INTRODUCTION
bull METHODS
bull RESULT
bull DISCUSSION
bull Recommendation
2
3
Non-alcoholic fatty liver disease (NAFLD) and its progressive form non-alcoholic steatohepatitis (NASH) are among the most prevalent of liver diseases worldwide
Approximately 20 to 30 of the adult population has NAFLD making it the most common liver disease in developed countries
The incidence is as high as 50ndash85 in people with pre-diabetes and diabetes
Diet is a modifiable risk factor that can potentially be targetedin both the prevention and treatment of NAFLD
4
Hepatocellular carcinoma
Lead to cirrhosis and its
complication include
portal hypertensive
bleeding
Hepatic decompensation
NAFLD
5
1bull demonstrated a significant improvement in insulin sensitivity and
hepatic steatosis with the MedDiet compared to the low fat diet group
2
bull aims to replicate the findings of Ryan et alrsquos pilot study in alarger cohort of participants with NAFLD in a more translatable environment and with assessment of sustainability
3bull aims to investigate the effects of adhering to the MedDiet as compared
to a low fat diet
Pilot data to support the shift from current dietary therapy to a novel MedDietintervention of patients with NAFLD has been published by Ryan et al in NAFLD patients This study
6
lower incidence of chronic disease
including CVD
Obesity
Dementia
Some cancers
Overall mortalityAnd keep you young nourish your body
7
12 week multi-centre
parallel randomisedcontrolled trial of a Med Diet versus a Low Fat Diet (LFD)
8
Are Non-English speaking
Consume on average gt140 gweek of alcohol (men and women)
Are taking the following medicationsimmunosuppressants amiodarone andor perhexiline
Have a HbA1c score exceeding 8
Have clinically relevant pulmonary gastro-intestinal renal metabolic hematological neurological
Are women who are pregnant
Have psychosocial or gastrointestinal (eg malabsorptiveconditions eg coeliac)
Age gt18 years
(BMI) between 20 and 399 kgm2
diagnosis of NAFLD determined
by routine ultrasound or biopsy
insulin resistance based on a HOMA IR score of gt2 and at least one elevated
serum ALT level (gt20 UL female gt30 UL male) during the past 6 months
9
10
The intervention is based on
11
LOW FAT DIETMEDITERRANEAN FOOD PYRAMID VS
12
All participants will be provided with written resources specifically designed to explain the and how it can be successfully followed and adhered to These resourcestMedDie
include
A food pyramid
healthy eating guidelines and tips
meal plans
recipes in the form of The Mediterranean Diet
a shopping list label reading
Participants will also be supplied with extra virgin olive oil
nuts
canned legumes
Fish
Breakfast is also provided on the day of all face to face appointments
13
Low fat diet
The LFD group will follow the same structure as theMedDiet arm with three face to face consultations atbaseline 6 weeks (mid intervention) and 12 weeks (endof intervention)
There will also be the same number of phone call follow ups at weeks 2 4 and 9
Participants will also be given a supermarket gift voucher to purchase some of the suggested food items
Breakfast is also provided on the day of all face to faceappointments
14
patients in the MedDiet
had significant improvements in insulin sensitivity as determinedby a 3-hour hyperinsulinaemic-euglycaemic clamp
significant reduction (39 ) in hepatic steatosis
low fat Diet
no significant improvement in insulin sensitivity and only a 7 reduction of hepatic steatosis with the low fat high carbohydrate diet
The changes observed in the intervention group were without a significantreduction in weight
15
The MedDiet has positive effects on insulin sensitivity which has been attributed to
the high content of bio-active phytochemicals with a range of antioxidant and anti-inflammatory activity
The MedDiet is characterised by a specific fatty acid profile low in saturated fat (7ndash8 of total energy) and high in monounsaturated fat(20 of total energy)
16
Although environmental influences such as diet have awell-established association with disease it is important to acknowledge that the interplay of genetics and environment are a widely accepted influence in disease outcomes
Currently there are no safe or effective proven therapiesfor the treatment of patients with NAFLD or NASH While diet and lifestyle changes focussing on achievingweight loss are the accepted recommendations for this patientGroupEnjoy your food eat whatrsquos good for you in moderation and remember the words of
ldquoLet food be the medicine and medicine be the foodrdquo
17
controlled trial of randomisedA ) 2016J( AmandaStuart KElena Sa Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA) study
3-0426-016-12876s118610)pp 14(16protocol
httpwwwdietplan-101commediterranean-diet-meal-planning-things-to-keep-in-mind
18
Thank you for your attention
Any questions
3
Non-alcoholic fatty liver disease (NAFLD) and its progressive form non-alcoholic steatohepatitis (NASH) are among the most prevalent of liver diseases worldwide
Approximately 20 to 30 of the adult population has NAFLD making it the most common liver disease in developed countries
The incidence is as high as 50ndash85 in people with pre-diabetes and diabetes
Diet is a modifiable risk factor that can potentially be targetedin both the prevention and treatment of NAFLD
4
Hepatocellular carcinoma
Lead to cirrhosis and its
complication include
portal hypertensive
bleeding
Hepatic decompensation
NAFLD
5
1bull demonstrated a significant improvement in insulin sensitivity and
hepatic steatosis with the MedDiet compared to the low fat diet group
2
bull aims to replicate the findings of Ryan et alrsquos pilot study in alarger cohort of participants with NAFLD in a more translatable environment and with assessment of sustainability
3bull aims to investigate the effects of adhering to the MedDiet as compared
to a low fat diet
Pilot data to support the shift from current dietary therapy to a novel MedDietintervention of patients with NAFLD has been published by Ryan et al in NAFLD patients This study
6
lower incidence of chronic disease
including CVD
Obesity
Dementia
Some cancers
Overall mortalityAnd keep you young nourish your body
7
12 week multi-centre
parallel randomisedcontrolled trial of a Med Diet versus a Low Fat Diet (LFD)
8
Are Non-English speaking
Consume on average gt140 gweek of alcohol (men and women)
Are taking the following medicationsimmunosuppressants amiodarone andor perhexiline
Have a HbA1c score exceeding 8
Have clinically relevant pulmonary gastro-intestinal renal metabolic hematological neurological
Are women who are pregnant
Have psychosocial or gastrointestinal (eg malabsorptiveconditions eg coeliac)
Age gt18 years
(BMI) between 20 and 399 kgm2
diagnosis of NAFLD determined
by routine ultrasound or biopsy
insulin resistance based on a HOMA IR score of gt2 and at least one elevated
serum ALT level (gt20 UL female gt30 UL male) during the past 6 months
9
10
The intervention is based on
11
LOW FAT DIETMEDITERRANEAN FOOD PYRAMID VS
12
All participants will be provided with written resources specifically designed to explain the and how it can be successfully followed and adhered to These resourcestMedDie
include
A food pyramid
healthy eating guidelines and tips
meal plans
recipes in the form of The Mediterranean Diet
a shopping list label reading
Participants will also be supplied with extra virgin olive oil
nuts
canned legumes
Fish
Breakfast is also provided on the day of all face to face appointments
13
Low fat diet
The LFD group will follow the same structure as theMedDiet arm with three face to face consultations atbaseline 6 weeks (mid intervention) and 12 weeks (endof intervention)
There will also be the same number of phone call follow ups at weeks 2 4 and 9
Participants will also be given a supermarket gift voucher to purchase some of the suggested food items
Breakfast is also provided on the day of all face to faceappointments
14
patients in the MedDiet
had significant improvements in insulin sensitivity as determinedby a 3-hour hyperinsulinaemic-euglycaemic clamp
significant reduction (39 ) in hepatic steatosis
low fat Diet
no significant improvement in insulin sensitivity and only a 7 reduction of hepatic steatosis with the low fat high carbohydrate diet
The changes observed in the intervention group were without a significantreduction in weight
15
The MedDiet has positive effects on insulin sensitivity which has been attributed to
the high content of bio-active phytochemicals with a range of antioxidant and anti-inflammatory activity
The MedDiet is characterised by a specific fatty acid profile low in saturated fat (7ndash8 of total energy) and high in monounsaturated fat(20 of total energy)
16
Although environmental influences such as diet have awell-established association with disease it is important to acknowledge that the interplay of genetics and environment are a widely accepted influence in disease outcomes
Currently there are no safe or effective proven therapiesfor the treatment of patients with NAFLD or NASH While diet and lifestyle changes focussing on achievingweight loss are the accepted recommendations for this patientGroupEnjoy your food eat whatrsquos good for you in moderation and remember the words of
ldquoLet food be the medicine and medicine be the foodrdquo
17
controlled trial of randomisedA ) 2016J( AmandaStuart KElena Sa Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA) study
3-0426-016-12876s118610)pp 14(16protocol
httpwwwdietplan-101commediterranean-diet-meal-planning-things-to-keep-in-mind
18
Thank you for your attention
Any questions
4
Hepatocellular carcinoma
Lead to cirrhosis and its
complication include
portal hypertensive
bleeding
Hepatic decompensation
NAFLD
5
1bull demonstrated a significant improvement in insulin sensitivity and
hepatic steatosis with the MedDiet compared to the low fat diet group
2
bull aims to replicate the findings of Ryan et alrsquos pilot study in alarger cohort of participants with NAFLD in a more translatable environment and with assessment of sustainability
3bull aims to investigate the effects of adhering to the MedDiet as compared
to a low fat diet
Pilot data to support the shift from current dietary therapy to a novel MedDietintervention of patients with NAFLD has been published by Ryan et al in NAFLD patients This study
6
lower incidence of chronic disease
including CVD
Obesity
Dementia
Some cancers
Overall mortalityAnd keep you young nourish your body
7
12 week multi-centre
parallel randomisedcontrolled trial of a Med Diet versus a Low Fat Diet (LFD)
8
Are Non-English speaking
Consume on average gt140 gweek of alcohol (men and women)
Are taking the following medicationsimmunosuppressants amiodarone andor perhexiline
Have a HbA1c score exceeding 8
Have clinically relevant pulmonary gastro-intestinal renal metabolic hematological neurological
Are women who are pregnant
Have psychosocial or gastrointestinal (eg malabsorptiveconditions eg coeliac)
Age gt18 years
(BMI) between 20 and 399 kgm2
diagnosis of NAFLD determined
by routine ultrasound or biopsy
insulin resistance based on a HOMA IR score of gt2 and at least one elevated
serum ALT level (gt20 UL female gt30 UL male) during the past 6 months
9
10
The intervention is based on
11
LOW FAT DIETMEDITERRANEAN FOOD PYRAMID VS
12
All participants will be provided with written resources specifically designed to explain the and how it can be successfully followed and adhered to These resourcestMedDie
include
A food pyramid
healthy eating guidelines and tips
meal plans
recipes in the form of The Mediterranean Diet
a shopping list label reading
Participants will also be supplied with extra virgin olive oil
nuts
canned legumes
Fish
Breakfast is also provided on the day of all face to face appointments
13
Low fat diet
The LFD group will follow the same structure as theMedDiet arm with three face to face consultations atbaseline 6 weeks (mid intervention) and 12 weeks (endof intervention)
There will also be the same number of phone call follow ups at weeks 2 4 and 9
Participants will also be given a supermarket gift voucher to purchase some of the suggested food items
Breakfast is also provided on the day of all face to faceappointments
14
patients in the MedDiet
had significant improvements in insulin sensitivity as determinedby a 3-hour hyperinsulinaemic-euglycaemic clamp
significant reduction (39 ) in hepatic steatosis
low fat Diet
no significant improvement in insulin sensitivity and only a 7 reduction of hepatic steatosis with the low fat high carbohydrate diet
The changes observed in the intervention group were without a significantreduction in weight
15
The MedDiet has positive effects on insulin sensitivity which has been attributed to
the high content of bio-active phytochemicals with a range of antioxidant and anti-inflammatory activity
The MedDiet is characterised by a specific fatty acid profile low in saturated fat (7ndash8 of total energy) and high in monounsaturated fat(20 of total energy)
16
Although environmental influences such as diet have awell-established association with disease it is important to acknowledge that the interplay of genetics and environment are a widely accepted influence in disease outcomes
Currently there are no safe or effective proven therapiesfor the treatment of patients with NAFLD or NASH While diet and lifestyle changes focussing on achievingweight loss are the accepted recommendations for this patientGroupEnjoy your food eat whatrsquos good for you in moderation and remember the words of
ldquoLet food be the medicine and medicine be the foodrdquo
17
controlled trial of randomisedA ) 2016J( AmandaStuart KElena Sa Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA) study
3-0426-016-12876s118610)pp 14(16protocol
httpwwwdietplan-101commediterranean-diet-meal-planning-things-to-keep-in-mind
18
Thank you for your attention
Any questions
5
1bull demonstrated a significant improvement in insulin sensitivity and
hepatic steatosis with the MedDiet compared to the low fat diet group
2
bull aims to replicate the findings of Ryan et alrsquos pilot study in alarger cohort of participants with NAFLD in a more translatable environment and with assessment of sustainability
3bull aims to investigate the effects of adhering to the MedDiet as compared
to a low fat diet
Pilot data to support the shift from current dietary therapy to a novel MedDietintervention of patients with NAFLD has been published by Ryan et al in NAFLD patients This study
6
lower incidence of chronic disease
including CVD
Obesity
Dementia
Some cancers
Overall mortalityAnd keep you young nourish your body
7
12 week multi-centre
parallel randomisedcontrolled trial of a Med Diet versus a Low Fat Diet (LFD)
8
Are Non-English speaking
Consume on average gt140 gweek of alcohol (men and women)
Are taking the following medicationsimmunosuppressants amiodarone andor perhexiline
Have a HbA1c score exceeding 8
Have clinically relevant pulmonary gastro-intestinal renal metabolic hematological neurological
Are women who are pregnant
Have psychosocial or gastrointestinal (eg malabsorptiveconditions eg coeliac)
Age gt18 years
(BMI) between 20 and 399 kgm2
diagnosis of NAFLD determined
by routine ultrasound or biopsy
insulin resistance based on a HOMA IR score of gt2 and at least one elevated
serum ALT level (gt20 UL female gt30 UL male) during the past 6 months
9
10
The intervention is based on
11
LOW FAT DIETMEDITERRANEAN FOOD PYRAMID VS
12
All participants will be provided with written resources specifically designed to explain the and how it can be successfully followed and adhered to These resourcestMedDie
include
A food pyramid
healthy eating guidelines and tips
meal plans
recipes in the form of The Mediterranean Diet
a shopping list label reading
Participants will also be supplied with extra virgin olive oil
nuts
canned legumes
Fish
Breakfast is also provided on the day of all face to face appointments
13
Low fat diet
The LFD group will follow the same structure as theMedDiet arm with three face to face consultations atbaseline 6 weeks (mid intervention) and 12 weeks (endof intervention)
There will also be the same number of phone call follow ups at weeks 2 4 and 9
Participants will also be given a supermarket gift voucher to purchase some of the suggested food items
Breakfast is also provided on the day of all face to faceappointments
14
patients in the MedDiet
had significant improvements in insulin sensitivity as determinedby a 3-hour hyperinsulinaemic-euglycaemic clamp
significant reduction (39 ) in hepatic steatosis
low fat Diet
no significant improvement in insulin sensitivity and only a 7 reduction of hepatic steatosis with the low fat high carbohydrate diet
The changes observed in the intervention group were without a significantreduction in weight
15
The MedDiet has positive effects on insulin sensitivity which has been attributed to
the high content of bio-active phytochemicals with a range of antioxidant and anti-inflammatory activity
The MedDiet is characterised by a specific fatty acid profile low in saturated fat (7ndash8 of total energy) and high in monounsaturated fat(20 of total energy)
16
Although environmental influences such as diet have awell-established association with disease it is important to acknowledge that the interplay of genetics and environment are a widely accepted influence in disease outcomes
Currently there are no safe or effective proven therapiesfor the treatment of patients with NAFLD or NASH While diet and lifestyle changes focussing on achievingweight loss are the accepted recommendations for this patientGroupEnjoy your food eat whatrsquos good for you in moderation and remember the words of
ldquoLet food be the medicine and medicine be the foodrdquo
17
controlled trial of randomisedA ) 2016J( AmandaStuart KElena Sa Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA) study
3-0426-016-12876s118610)pp 14(16protocol
httpwwwdietplan-101commediterranean-diet-meal-planning-things-to-keep-in-mind
18
Thank you for your attention
Any questions
6
lower incidence of chronic disease
including CVD
Obesity
Dementia
Some cancers
Overall mortalityAnd keep you young nourish your body
7
12 week multi-centre
parallel randomisedcontrolled trial of a Med Diet versus a Low Fat Diet (LFD)
8
Are Non-English speaking
Consume on average gt140 gweek of alcohol (men and women)
Are taking the following medicationsimmunosuppressants amiodarone andor perhexiline
Have a HbA1c score exceeding 8
Have clinically relevant pulmonary gastro-intestinal renal metabolic hematological neurological
Are women who are pregnant
Have psychosocial or gastrointestinal (eg malabsorptiveconditions eg coeliac)
Age gt18 years
(BMI) between 20 and 399 kgm2
diagnosis of NAFLD determined
by routine ultrasound or biopsy
insulin resistance based on a HOMA IR score of gt2 and at least one elevated
serum ALT level (gt20 UL female gt30 UL male) during the past 6 months
9
10
The intervention is based on
11
LOW FAT DIETMEDITERRANEAN FOOD PYRAMID VS
12
All participants will be provided with written resources specifically designed to explain the and how it can be successfully followed and adhered to These resourcestMedDie
include
A food pyramid
healthy eating guidelines and tips
meal plans
recipes in the form of The Mediterranean Diet
a shopping list label reading
Participants will also be supplied with extra virgin olive oil
nuts
canned legumes
Fish
Breakfast is also provided on the day of all face to face appointments
13
Low fat diet
The LFD group will follow the same structure as theMedDiet arm with three face to face consultations atbaseline 6 weeks (mid intervention) and 12 weeks (endof intervention)
There will also be the same number of phone call follow ups at weeks 2 4 and 9
Participants will also be given a supermarket gift voucher to purchase some of the suggested food items
Breakfast is also provided on the day of all face to faceappointments
14
patients in the MedDiet
had significant improvements in insulin sensitivity as determinedby a 3-hour hyperinsulinaemic-euglycaemic clamp
significant reduction (39 ) in hepatic steatosis
low fat Diet
no significant improvement in insulin sensitivity and only a 7 reduction of hepatic steatosis with the low fat high carbohydrate diet
The changes observed in the intervention group were without a significantreduction in weight
15
The MedDiet has positive effects on insulin sensitivity which has been attributed to
the high content of bio-active phytochemicals with a range of antioxidant and anti-inflammatory activity
The MedDiet is characterised by a specific fatty acid profile low in saturated fat (7ndash8 of total energy) and high in monounsaturated fat(20 of total energy)
16
Although environmental influences such as diet have awell-established association with disease it is important to acknowledge that the interplay of genetics and environment are a widely accepted influence in disease outcomes
Currently there are no safe or effective proven therapiesfor the treatment of patients with NAFLD or NASH While diet and lifestyle changes focussing on achievingweight loss are the accepted recommendations for this patientGroupEnjoy your food eat whatrsquos good for you in moderation and remember the words of
ldquoLet food be the medicine and medicine be the foodrdquo
17
controlled trial of randomisedA ) 2016J( AmandaStuart KElena Sa Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA) study
3-0426-016-12876s118610)pp 14(16protocol
httpwwwdietplan-101commediterranean-diet-meal-planning-things-to-keep-in-mind
18
Thank you for your attention
Any questions
7
12 week multi-centre
parallel randomisedcontrolled trial of a Med Diet versus a Low Fat Diet (LFD)
8
Are Non-English speaking
Consume on average gt140 gweek of alcohol (men and women)
Are taking the following medicationsimmunosuppressants amiodarone andor perhexiline
Have a HbA1c score exceeding 8
Have clinically relevant pulmonary gastro-intestinal renal metabolic hematological neurological
Are women who are pregnant
Have psychosocial or gastrointestinal (eg malabsorptiveconditions eg coeliac)
Age gt18 years
(BMI) between 20 and 399 kgm2
diagnosis of NAFLD determined
by routine ultrasound or biopsy
insulin resistance based on a HOMA IR score of gt2 and at least one elevated
serum ALT level (gt20 UL female gt30 UL male) during the past 6 months
9
10
The intervention is based on
11
LOW FAT DIETMEDITERRANEAN FOOD PYRAMID VS
12
All participants will be provided with written resources specifically designed to explain the and how it can be successfully followed and adhered to These resourcestMedDie
include
A food pyramid
healthy eating guidelines and tips
meal plans
recipes in the form of The Mediterranean Diet
a shopping list label reading
Participants will also be supplied with extra virgin olive oil
nuts
canned legumes
Fish
Breakfast is also provided on the day of all face to face appointments
13
Low fat diet
The LFD group will follow the same structure as theMedDiet arm with three face to face consultations atbaseline 6 weeks (mid intervention) and 12 weeks (endof intervention)
There will also be the same number of phone call follow ups at weeks 2 4 and 9
Participants will also be given a supermarket gift voucher to purchase some of the suggested food items
Breakfast is also provided on the day of all face to faceappointments
14
patients in the MedDiet
had significant improvements in insulin sensitivity as determinedby a 3-hour hyperinsulinaemic-euglycaemic clamp
significant reduction (39 ) in hepatic steatosis
low fat Diet
no significant improvement in insulin sensitivity and only a 7 reduction of hepatic steatosis with the low fat high carbohydrate diet
The changes observed in the intervention group were without a significantreduction in weight
15
The MedDiet has positive effects on insulin sensitivity which has been attributed to
the high content of bio-active phytochemicals with a range of antioxidant and anti-inflammatory activity
The MedDiet is characterised by a specific fatty acid profile low in saturated fat (7ndash8 of total energy) and high in monounsaturated fat(20 of total energy)
16
Although environmental influences such as diet have awell-established association with disease it is important to acknowledge that the interplay of genetics and environment are a widely accepted influence in disease outcomes
Currently there are no safe or effective proven therapiesfor the treatment of patients with NAFLD or NASH While diet and lifestyle changes focussing on achievingweight loss are the accepted recommendations for this patientGroupEnjoy your food eat whatrsquos good for you in moderation and remember the words of
ldquoLet food be the medicine and medicine be the foodrdquo
17
controlled trial of randomisedA ) 2016J( AmandaStuart KElena Sa Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA) study
3-0426-016-12876s118610)pp 14(16protocol
httpwwwdietplan-101commediterranean-diet-meal-planning-things-to-keep-in-mind
18
Thank you for your attention
Any questions
8
Are Non-English speaking
Consume on average gt140 gweek of alcohol (men and women)
Are taking the following medicationsimmunosuppressants amiodarone andor perhexiline
Have a HbA1c score exceeding 8
Have clinically relevant pulmonary gastro-intestinal renal metabolic hematological neurological
Are women who are pregnant
Have psychosocial or gastrointestinal (eg malabsorptiveconditions eg coeliac)
Age gt18 years
(BMI) between 20 and 399 kgm2
diagnosis of NAFLD determined
by routine ultrasound or biopsy
insulin resistance based on a HOMA IR score of gt2 and at least one elevated
serum ALT level (gt20 UL female gt30 UL male) during the past 6 months
9
10
The intervention is based on
11
LOW FAT DIETMEDITERRANEAN FOOD PYRAMID VS
12
All participants will be provided with written resources specifically designed to explain the and how it can be successfully followed and adhered to These resourcestMedDie
include
A food pyramid
healthy eating guidelines and tips
meal plans
recipes in the form of The Mediterranean Diet
a shopping list label reading
Participants will also be supplied with extra virgin olive oil
nuts
canned legumes
Fish
Breakfast is also provided on the day of all face to face appointments
13
Low fat diet
The LFD group will follow the same structure as theMedDiet arm with three face to face consultations atbaseline 6 weeks (mid intervention) and 12 weeks (endof intervention)
There will also be the same number of phone call follow ups at weeks 2 4 and 9
Participants will also be given a supermarket gift voucher to purchase some of the suggested food items
Breakfast is also provided on the day of all face to faceappointments
14
patients in the MedDiet
had significant improvements in insulin sensitivity as determinedby a 3-hour hyperinsulinaemic-euglycaemic clamp
significant reduction (39 ) in hepatic steatosis
low fat Diet
no significant improvement in insulin sensitivity and only a 7 reduction of hepatic steatosis with the low fat high carbohydrate diet
The changes observed in the intervention group were without a significantreduction in weight
15
The MedDiet has positive effects on insulin sensitivity which has been attributed to
the high content of bio-active phytochemicals with a range of antioxidant and anti-inflammatory activity
The MedDiet is characterised by a specific fatty acid profile low in saturated fat (7ndash8 of total energy) and high in monounsaturated fat(20 of total energy)
16
Although environmental influences such as diet have awell-established association with disease it is important to acknowledge that the interplay of genetics and environment are a widely accepted influence in disease outcomes
Currently there are no safe or effective proven therapiesfor the treatment of patients with NAFLD or NASH While diet and lifestyle changes focussing on achievingweight loss are the accepted recommendations for this patientGroupEnjoy your food eat whatrsquos good for you in moderation and remember the words of
ldquoLet food be the medicine and medicine be the foodrdquo
17
controlled trial of randomisedA ) 2016J( AmandaStuart KElena Sa Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA) study
3-0426-016-12876s118610)pp 14(16protocol
httpwwwdietplan-101commediterranean-diet-meal-planning-things-to-keep-in-mind
18
Thank you for your attention
Any questions
9
10
The intervention is based on
11
LOW FAT DIETMEDITERRANEAN FOOD PYRAMID VS
12
All participants will be provided with written resources specifically designed to explain the and how it can be successfully followed and adhered to These resourcestMedDie
include
A food pyramid
healthy eating guidelines and tips
meal plans
recipes in the form of The Mediterranean Diet
a shopping list label reading
Participants will also be supplied with extra virgin olive oil
nuts
canned legumes
Fish
Breakfast is also provided on the day of all face to face appointments
13
Low fat diet
The LFD group will follow the same structure as theMedDiet arm with three face to face consultations atbaseline 6 weeks (mid intervention) and 12 weeks (endof intervention)
There will also be the same number of phone call follow ups at weeks 2 4 and 9
Participants will also be given a supermarket gift voucher to purchase some of the suggested food items
Breakfast is also provided on the day of all face to faceappointments
14
patients in the MedDiet
had significant improvements in insulin sensitivity as determinedby a 3-hour hyperinsulinaemic-euglycaemic clamp
significant reduction (39 ) in hepatic steatosis
low fat Diet
no significant improvement in insulin sensitivity and only a 7 reduction of hepatic steatosis with the low fat high carbohydrate diet
The changes observed in the intervention group were without a significantreduction in weight
15
The MedDiet has positive effects on insulin sensitivity which has been attributed to
the high content of bio-active phytochemicals with a range of antioxidant and anti-inflammatory activity
The MedDiet is characterised by a specific fatty acid profile low in saturated fat (7ndash8 of total energy) and high in monounsaturated fat(20 of total energy)
16
Although environmental influences such as diet have awell-established association with disease it is important to acknowledge that the interplay of genetics and environment are a widely accepted influence in disease outcomes
Currently there are no safe or effective proven therapiesfor the treatment of patients with NAFLD or NASH While diet and lifestyle changes focussing on achievingweight loss are the accepted recommendations for this patientGroupEnjoy your food eat whatrsquos good for you in moderation and remember the words of
ldquoLet food be the medicine and medicine be the foodrdquo
17
controlled trial of randomisedA ) 2016J( AmandaStuart KElena Sa Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA) study
3-0426-016-12876s118610)pp 14(16protocol
httpwwwdietplan-101commediterranean-diet-meal-planning-things-to-keep-in-mind
18
Thank you for your attention
Any questions
10
The intervention is based on
11
LOW FAT DIETMEDITERRANEAN FOOD PYRAMID VS
12
All participants will be provided with written resources specifically designed to explain the and how it can be successfully followed and adhered to These resourcestMedDie
include
A food pyramid
healthy eating guidelines and tips
meal plans
recipes in the form of The Mediterranean Diet
a shopping list label reading
Participants will also be supplied with extra virgin olive oil
nuts
canned legumes
Fish
Breakfast is also provided on the day of all face to face appointments
13
Low fat diet
The LFD group will follow the same structure as theMedDiet arm with three face to face consultations atbaseline 6 weeks (mid intervention) and 12 weeks (endof intervention)
There will also be the same number of phone call follow ups at weeks 2 4 and 9
Participants will also be given a supermarket gift voucher to purchase some of the suggested food items
Breakfast is also provided on the day of all face to faceappointments
14
patients in the MedDiet
had significant improvements in insulin sensitivity as determinedby a 3-hour hyperinsulinaemic-euglycaemic clamp
significant reduction (39 ) in hepatic steatosis
low fat Diet
no significant improvement in insulin sensitivity and only a 7 reduction of hepatic steatosis with the low fat high carbohydrate diet
The changes observed in the intervention group were without a significantreduction in weight
15
The MedDiet has positive effects on insulin sensitivity which has been attributed to
the high content of bio-active phytochemicals with a range of antioxidant and anti-inflammatory activity
The MedDiet is characterised by a specific fatty acid profile low in saturated fat (7ndash8 of total energy) and high in monounsaturated fat(20 of total energy)
16
Although environmental influences such as diet have awell-established association with disease it is important to acknowledge that the interplay of genetics and environment are a widely accepted influence in disease outcomes
Currently there are no safe or effective proven therapiesfor the treatment of patients with NAFLD or NASH While diet and lifestyle changes focussing on achievingweight loss are the accepted recommendations for this patientGroupEnjoy your food eat whatrsquos good for you in moderation and remember the words of
ldquoLet food be the medicine and medicine be the foodrdquo
17
controlled trial of randomisedA ) 2016J( AmandaStuart KElena Sa Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA) study
3-0426-016-12876s118610)pp 14(16protocol
httpwwwdietplan-101commediterranean-diet-meal-planning-things-to-keep-in-mind
18
Thank you for your attention
Any questions
11
LOW FAT DIETMEDITERRANEAN FOOD PYRAMID VS
12
All participants will be provided with written resources specifically designed to explain the and how it can be successfully followed and adhered to These resourcestMedDie
include
A food pyramid
healthy eating guidelines and tips
meal plans
recipes in the form of The Mediterranean Diet
a shopping list label reading
Participants will also be supplied with extra virgin olive oil
nuts
canned legumes
Fish
Breakfast is also provided on the day of all face to face appointments
13
Low fat diet
The LFD group will follow the same structure as theMedDiet arm with three face to face consultations atbaseline 6 weeks (mid intervention) and 12 weeks (endof intervention)
There will also be the same number of phone call follow ups at weeks 2 4 and 9
Participants will also be given a supermarket gift voucher to purchase some of the suggested food items
Breakfast is also provided on the day of all face to faceappointments
14
patients in the MedDiet
had significant improvements in insulin sensitivity as determinedby a 3-hour hyperinsulinaemic-euglycaemic clamp
significant reduction (39 ) in hepatic steatosis
low fat Diet
no significant improvement in insulin sensitivity and only a 7 reduction of hepatic steatosis with the low fat high carbohydrate diet
The changes observed in the intervention group were without a significantreduction in weight
15
The MedDiet has positive effects on insulin sensitivity which has been attributed to
the high content of bio-active phytochemicals with a range of antioxidant and anti-inflammatory activity
The MedDiet is characterised by a specific fatty acid profile low in saturated fat (7ndash8 of total energy) and high in monounsaturated fat(20 of total energy)
16
Although environmental influences such as diet have awell-established association with disease it is important to acknowledge that the interplay of genetics and environment are a widely accepted influence in disease outcomes
Currently there are no safe or effective proven therapiesfor the treatment of patients with NAFLD or NASH While diet and lifestyle changes focussing on achievingweight loss are the accepted recommendations for this patientGroupEnjoy your food eat whatrsquos good for you in moderation and remember the words of
ldquoLet food be the medicine and medicine be the foodrdquo
17
controlled trial of randomisedA ) 2016J( AmandaStuart KElena Sa Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA) study
3-0426-016-12876s118610)pp 14(16protocol
httpwwwdietplan-101commediterranean-diet-meal-planning-things-to-keep-in-mind
18
Thank you for your attention
Any questions
12
All participants will be provided with written resources specifically designed to explain the and how it can be successfully followed and adhered to These resourcestMedDie
include
A food pyramid
healthy eating guidelines and tips
meal plans
recipes in the form of The Mediterranean Diet
a shopping list label reading
Participants will also be supplied with extra virgin olive oil
nuts
canned legumes
Fish
Breakfast is also provided on the day of all face to face appointments
13
Low fat diet
The LFD group will follow the same structure as theMedDiet arm with three face to face consultations atbaseline 6 weeks (mid intervention) and 12 weeks (endof intervention)
There will also be the same number of phone call follow ups at weeks 2 4 and 9
Participants will also be given a supermarket gift voucher to purchase some of the suggested food items
Breakfast is also provided on the day of all face to faceappointments
14
patients in the MedDiet
had significant improvements in insulin sensitivity as determinedby a 3-hour hyperinsulinaemic-euglycaemic clamp
significant reduction (39 ) in hepatic steatosis
low fat Diet
no significant improvement in insulin sensitivity and only a 7 reduction of hepatic steatosis with the low fat high carbohydrate diet
The changes observed in the intervention group were without a significantreduction in weight
15
The MedDiet has positive effects on insulin sensitivity which has been attributed to
the high content of bio-active phytochemicals with a range of antioxidant and anti-inflammatory activity
The MedDiet is characterised by a specific fatty acid profile low in saturated fat (7ndash8 of total energy) and high in monounsaturated fat(20 of total energy)
16
Although environmental influences such as diet have awell-established association with disease it is important to acknowledge that the interplay of genetics and environment are a widely accepted influence in disease outcomes
Currently there are no safe or effective proven therapiesfor the treatment of patients with NAFLD or NASH While diet and lifestyle changes focussing on achievingweight loss are the accepted recommendations for this patientGroupEnjoy your food eat whatrsquos good for you in moderation and remember the words of
ldquoLet food be the medicine and medicine be the foodrdquo
17
controlled trial of randomisedA ) 2016J( AmandaStuart KElena Sa Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA) study
3-0426-016-12876s118610)pp 14(16protocol
httpwwwdietplan-101commediterranean-diet-meal-planning-things-to-keep-in-mind
18
Thank you for your attention
Any questions
13
Low fat diet
The LFD group will follow the same structure as theMedDiet arm with three face to face consultations atbaseline 6 weeks (mid intervention) and 12 weeks (endof intervention)
There will also be the same number of phone call follow ups at weeks 2 4 and 9
Participants will also be given a supermarket gift voucher to purchase some of the suggested food items
Breakfast is also provided on the day of all face to faceappointments
14
patients in the MedDiet
had significant improvements in insulin sensitivity as determinedby a 3-hour hyperinsulinaemic-euglycaemic clamp
significant reduction (39 ) in hepatic steatosis
low fat Diet
no significant improvement in insulin sensitivity and only a 7 reduction of hepatic steatosis with the low fat high carbohydrate diet
The changes observed in the intervention group were without a significantreduction in weight
15
The MedDiet has positive effects on insulin sensitivity which has been attributed to
the high content of bio-active phytochemicals with a range of antioxidant and anti-inflammatory activity
The MedDiet is characterised by a specific fatty acid profile low in saturated fat (7ndash8 of total energy) and high in monounsaturated fat(20 of total energy)
16
Although environmental influences such as diet have awell-established association with disease it is important to acknowledge that the interplay of genetics and environment are a widely accepted influence in disease outcomes
Currently there are no safe or effective proven therapiesfor the treatment of patients with NAFLD or NASH While diet and lifestyle changes focussing on achievingweight loss are the accepted recommendations for this patientGroupEnjoy your food eat whatrsquos good for you in moderation and remember the words of
ldquoLet food be the medicine and medicine be the foodrdquo
17
controlled trial of randomisedA ) 2016J( AmandaStuart KElena Sa Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA) study
3-0426-016-12876s118610)pp 14(16protocol
httpwwwdietplan-101commediterranean-diet-meal-planning-things-to-keep-in-mind
18
Thank you for your attention
Any questions
14
patients in the MedDiet
had significant improvements in insulin sensitivity as determinedby a 3-hour hyperinsulinaemic-euglycaemic clamp
significant reduction (39 ) in hepatic steatosis
low fat Diet
no significant improvement in insulin sensitivity and only a 7 reduction of hepatic steatosis with the low fat high carbohydrate diet
The changes observed in the intervention group were without a significantreduction in weight
15
The MedDiet has positive effects on insulin sensitivity which has been attributed to
the high content of bio-active phytochemicals with a range of antioxidant and anti-inflammatory activity
The MedDiet is characterised by a specific fatty acid profile low in saturated fat (7ndash8 of total energy) and high in monounsaturated fat(20 of total energy)
16
Although environmental influences such as diet have awell-established association with disease it is important to acknowledge that the interplay of genetics and environment are a widely accepted influence in disease outcomes
Currently there are no safe or effective proven therapiesfor the treatment of patients with NAFLD or NASH While diet and lifestyle changes focussing on achievingweight loss are the accepted recommendations for this patientGroupEnjoy your food eat whatrsquos good for you in moderation and remember the words of
ldquoLet food be the medicine and medicine be the foodrdquo
17
controlled trial of randomisedA ) 2016J( AmandaStuart KElena Sa Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA) study
3-0426-016-12876s118610)pp 14(16protocol
httpwwwdietplan-101commediterranean-diet-meal-planning-things-to-keep-in-mind
18
Thank you for your attention
Any questions
15
The MedDiet has positive effects on insulin sensitivity which has been attributed to
the high content of bio-active phytochemicals with a range of antioxidant and anti-inflammatory activity
The MedDiet is characterised by a specific fatty acid profile low in saturated fat (7ndash8 of total energy) and high in monounsaturated fat(20 of total energy)
16
Although environmental influences such as diet have awell-established association with disease it is important to acknowledge that the interplay of genetics and environment are a widely accepted influence in disease outcomes
Currently there are no safe or effective proven therapiesfor the treatment of patients with NAFLD or NASH While diet and lifestyle changes focussing on achievingweight loss are the accepted recommendations for this patientGroupEnjoy your food eat whatrsquos good for you in moderation and remember the words of
ldquoLet food be the medicine and medicine be the foodrdquo
17
controlled trial of randomisedA ) 2016J( AmandaStuart KElena Sa Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA) study
3-0426-016-12876s118610)pp 14(16protocol
httpwwwdietplan-101commediterranean-diet-meal-planning-things-to-keep-in-mind
18
Thank you for your attention
Any questions
16
Although environmental influences such as diet have awell-established association with disease it is important to acknowledge that the interplay of genetics and environment are a widely accepted influence in disease outcomes
Currently there are no safe or effective proven therapiesfor the treatment of patients with NAFLD or NASH While diet and lifestyle changes focussing on achievingweight loss are the accepted recommendations for this patientGroupEnjoy your food eat whatrsquos good for you in moderation and remember the words of
ldquoLet food be the medicine and medicine be the foodrdquo
17
controlled trial of randomisedA ) 2016J( AmandaStuart KElena Sa Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA) study
3-0426-016-12876s118610)pp 14(16protocol
httpwwwdietplan-101commediterranean-diet-meal-planning-things-to-keep-in-mind
18
Thank you for your attention
Any questions
17
controlled trial of randomisedA ) 2016J( AmandaStuart KElena Sa Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA) study
3-0426-016-12876s118610)pp 14(16protocol
httpwwwdietplan-101commediterranean-diet-meal-planning-things-to-keep-in-mind
18
Thank you for your attention
Any questions
18
Thank you for your attention
Any questions