. 2019 Jan 24;20(4):569–587. doi: 10.1111/obr.12816

Table 1.

Characteristics of included studies

Study ID	Location	Funder	Population	Intervention	Comparator	Relevant Outcomes	Follow‐Up Rate
MR diet vs diet only
Ahrens 2003	USA	SlimFast	N = 95 BMI >25 kg/m² 87% Female	12‐week weight loss: Replace 2 of 3 meals with a liquid MR plus one self‐selected meal of conventional foods 10‐week weight maintenance: 1 MR and 2 self‐selected meals of conventional foods	12‐week weight loss: Self‐selected diet, based on diabetic exchange ~5021 kJ (1200 kcal)/day for women, 6276 kJ (1500 kcal)/day for men 10‐week weight maintenance: Healthy self‐selected diet and control of energy intake as desired	Weight BMI	20% (Not reported by group)
Cheskin 2008	USA	Medifast Inc.	N = 119 BMI 25‐40 kg/m² Type 2 diabetes 56% Female	34‐week weight loss: 25% energy deficit diet with 50%‐60% energy provided by MR suitable for diabetics, the remainder provided by self‐selected conventional foods. 52‐week weight maintenance: Rerandomized to either 26‐week MR followed by 26‐week control intervention, or 26‐week control intervention followed by 26‐week MR.	34‐week weight loss: 25% energy‐deficit diet ADA recommendations 52‐week maintenance: Continued at a lower energy restriction for maintenance	Weight BMI Body fat (%) Waist circumference Fasting glucose Insulin Total cholesterol Systolic blood pressure Diastolic blood pressure Triglycerides HbA1C Medication use	MR: 57% Control: 29%
Ditschuneit 2001	Germany	SlimFast	N = 100 BMI 25‐40 kg/m² 79% Female	3‐month weight loss: 2 MR + regular meal 48‐month weight maintenance: Replace 1 meal and 1 snack with MR.	3‐month weight loss: Low‐energy diet of conventional foods providing 5021 to 6276 kJ (1200 to 1500 kcal)/day. Three meals (breakfast, lunch, and dinner) and two snacks were recommended. 48‐month weight maintenance: Replace 1 meal and 1 snack with MR.	Weight Waist circumference Fasting glucose Insulin Total cholesterol LDL cholesterol Systolic blood pressure Diastolic blood pressure	MR 84% Control: 72%
Khoo 2011	Australia	National Heart Foundation Australia and Medical Benefits Foundation	N = 31 BMI >30 kg/m² WC >102 cm Type 2 diabetes 0% Female	52‐week weight loss: 8 weeks: Energy deficit 2 MR + small meal of self‐selected conventional foods. 44 weeks: Switched to the control diet	52‐week weight loss: High protein ~2510 kJ (600 kcal) energy‐deficit diet Based on the Commonwealth Scientific Industrial and Research Organisation (CSIRO) total well‐being diet	Weight Waist circumference Plasma glucose Insulin Triglycerides LDL cholesterol HDL cholesterol	MR: 47% Control: 58%
Khoo 2013	Singapore	The SingHealth Foundation and Changi General Hospital	N = 48 BMI >27.5 kg/m² Men with erectile dysfunction 0% Female	12‐week weight loss: ~1674 kJ (400 kcal) energy deficit comprising 2 liquid MR + self‐selected meal	12‐week weight loss: Conventional diet ~1674 kJ (400 kcal) energy deficit	Weight BMI Waist circumference Body fat (%) Plasma glucose Plasma insulin Systolic blood pressure Diastolic blood pressure	MR: 58% Control: 54%
Rothacker 2001	USA	Maryland Chapter of the Arthritis Foundation	N = 75 BMI 25‐32 kg/m² 100% Female	1‐year weight loss: Replace 1 or more meals with liquid MR	1‐year weight loss: Low‐energy low‐fat diet of ~5021 kJ (1200 kcal)/day	Weight Fat mass Lean body mass Fat (%)	MR: 84% Control: 87%
	MR diet + support vs diet + support
Ashley 2001	USA	Slim fast	N = 113 BMI 25‐50 kg/m² Premenopausal women 100% Female	1‐year weight loss: MR (dietician led): Small classes (8‐10 participants per class) Weekly for the first 3 months, biweekly for the next 3 months and monthly for the final 6 months. Diet consisting of replacing 2 of the 3 main meals (breakfast, lunch, or dinner) with MR shakes or bars. MR physician/nurse led: Brief (10/15 min) biweekly visits with a physician or nurse. Diet consisting of replacing 2 of the 3 main meals (breakfast, lunch, or dinner) with MR shakes or bars.	1‐year weight loss: Small dietician‐led classes (8‐10 participants per class) Weekly for the first 3 months, biweekly for the next 3 months and monthly for the final 6 months. All meals and snacks prepared from self‐selected conventional foods ~5021 kJ (1200 kcal)/day using the US Department of Agriculture food guide pyramid.	Weight Waist circumference Body fat (skinfold) Glucose Insulin Total cholesterol LDL cholesterol HDL cholesterol Triglycerides Systolic blood pressure Diastolic blood pressure	65% overall (not reported by group)
Ashley 2007	USA	SlimFast/Unilever	N = 96 BMI 25‐35 kg/m² 100% Female	1‐year weight loss: Replace 2 of 3 main meals with MR drinks or bars. Bimonthly classes for 6 months followed by monthly classes for 6 months.	1‐year weight loss: Diet plan based of ~5021 kJ (1200 kcal)/day based on self‐selection of conventional foods for meals and snacks using the USDA food guide pyramid. Bimonthly classes of 6 months followed by monthly classes for a further 6 months	Weight (kg) BMI Body fat (%) Waist circumference	MR: 73% Control: 73%
Chaiyasoot 2018	Thailand	Slimwell	N = 110 BMI >25 Metabolic syndrome 83% Female	12 weeks: Replace 2 main meals with one MR for the duration of the 12 week intervention. Group session at baseline followed by 4 individual sessions with dietician.	12 weeks: Baseline group session and 4 individual sessions with dietitian who advised an energy restriction diet based on ~2092‐4184 kJ (500‐100 kcal)/day energy restriction.	Weight (kg)	MR: 72% Control:84%
Chee 2017	Malaysia	Abbott Nutrition Malaysia	N = 230 BMI >23 kg/m² Type 2 diabetes 63% Female	6 months MR (MI): Replace 1 or 2 meals with a diabetes‐specific formula meal replacement. Behavioural support provided using motivational interview. MR (CC): Replace 1 or 2 meals with a diabetes‐specific formula meal replacement. Behavioural support provided using conventional counselling.	6 months: Followed the clinical care pathway of the Malaysian clinical practice guidelines for type 2 diabetes mellitus (2009) and received advice to follow a conventional low‐calorie diet plan 5021 kJ (1200 kcal) or 6276 kJ (1500 kcal)/day using normal foods with standard diabetes support and lifestyle education.	Weight (kg)	MR (MI): 88% MR (CC): 70% Control: 85%
Davis 2010	USA	Medifast Inc.	N = 90 BMI 30‐50 kg/m² 71% Female	16‐week weight loss: 5 MR + a self‐selected meal. Biweekly consultations with a dietician for dietary and behavioural counselling. 24‐week weight maintenance: 2 meetings with dietician at 12‐week intervals.	16‐week weight loss: ~4184 kJ (1000 kcal)/day diet plan plus multivitamin supplement. Biweekly consultations with a dietician for dietary and behavioural counselling. 24‐week weight maintenance: 2 meetings with dietician at 12‐week intervals.	Weight (kg) Waist circumference Body fat (%) Total cholesterol HDL cholesterol LDL cholesterol Triglycerides Systolic BP Diastolic BP	MR: 58% Control: 44%
Flechtner‐Mors 2010	Germany	University of Ulm and Herbalife Inc.	N = 100 Overweight and obese (BMI 27‐45 kg/m²), metabolic syndrome 80% Female	3‐month weight loss: Diet instructions to follow diet high protein with energy deficit of ~2092 kJ (500 kcal)/day based on consuming 2 protein‐enriched MR plus one conventional meal and 2 snacks. 9‐month weight maintenance: 1 MR two conventional meals and two snacks	3‐month weight loss: Diet instructions to follow diet with conventional protein content with energy deficit of ~2092 kJ (500 kcal)/day, 3 conventional meals 2 snacks 9‐month weight maintenance: 2 conventional meals 2 conventional snacks and 1 MR	Weight BMI Body fat (%) Blood glucose Insulin HbA1c Total cholesterol HDL cholesterol Triglycerides Adverse events	MR: 56% Control: 78%
Li 2005	USA	Not disclosed‐meal replacements provided by SlimFast foods Co. Inc.	N = 104 BMI 27‐40 kg/m² Type 2 diabetics 62% Female	1 year: Individual consultation with a dietician at baseline and weekly for 2 months, then monthly for the remainder First 5 days: 3 soy MR and advice to add fruits and vegetables to their intake Day 6‐3 months: 2 MR plus one meal of self‐selected foods 3 months‐1 year: 1 or 2 MR plus 2 sensible meals.	1 year: Individual consultation with a dietician at baseline and weekly for 2 months, then monthly for the remainder. Individualized meal plan based on ADA exchanges, target reduction in intake of ~2092 kJ (500 kcal)/day.	Weight BMI Glucose Insulin HbA1c Total cholesterol LDL cholesterol HDL cholesterol Triglycerides	MR: 81% Control: 67%
Lowe 2018	USA	National Institutes of Health (NIH)	N = 181 BMI 27‐45 kg/m² 84% Female	1 year: Weekly groups for 6 mo, then biweekly for 6 mo. During months 1‐6 participants were advised to replace 2 meals with MR product. In months 7‐12 switched to replacing 1 meal and 1 snack with MR product.	1 year: Weekly groups for 6 mo, then biweekly for 6 mo. Following materials from lifestyle, exercise, attitude relationships and nutrition (LEARN) and diabetes prevention program manual. Focus on weight loss months 1‐6 and weight maintenance months 7‐12.	Weight (kg)	MR: 73% Control: 81%
Ptomey 2017	USA	National Institutes of Diabetes, Digestive and Kidney Diseases (NIDDK)	N = 150 BMI >25 kg/m² Intellectual developmental disabilities 57% Female	18‐month weight loss: Participants and study partners taught how to prepare and consume 2 portion‐controlled main meal MR and 2 MR shakes a day with additional meal of self‐selected conventional foods according to a guide. Health educators conducted monthly home visits.	18‐month weight loss: Participants and study partners taught how to follow a 2092‐2929 kJ (500‐700 kcal)/day energy deficit diet following Myplate approach. Health educators conducted monthly home visits.	Weight BMI Waist circumference	MR: 69% Control: 65%
Rolls 2017	USA	National Institutes of Diabetes, Digestive and Kidney Diseases (NIDDK)	N = 124 BMI 28‐45 kg/m² 100% Female	1‐year weight loss: Participants met individually with a dietician for 19 sessions. They were instructed to eat preportioned main dishes daily for lunch and dinner during months 1‐3 of the study and were encouraged to continue this practice subsequently.	1‐year weight loss: Participants met individually with a dietician for 19 sessions. Instructed to follow US dietary guidelines emphasizing eating less whilst making healthy choices from all food groups.	Weight Glucose HbA1c Total cholesterol LDL cholesterol HDL cholesterol Triglycerides Systolic blood pressure Diastolic blood pressure	MR: 82% Control:82%
MR diet + support vs diet only
Rock 2007	USA	Jenny Craig Inc.	N = 70 BMI 25‐40 kg/m² Minimum 15 kg overweight 100% F	12‐month weight loss: Weekly one‐to‐one contacts with a counsellor, with follow‐up telephone and e‐mail contacts and web site/message board availability. Energy reduced diet with prepackaged prepared foods typically providing 3347 kJ (800 kcal)/day, with the remainder provided by self‐selected conventional food. A goal is 30 minutes of physical activity on 5 or more days of the week.	1‐year weight loss: Consultation with a dietician at baseline and 16 weeks who provided a diet and physical activity plan to promote weight loss.	Weight BMI Waist circumference Hip circumference Insulin Total cholesterol LDL cholesterol HDL cholesterol Triglycerides	MR: 91% Control: 94%
Shikany 2013	USA	Medifast Inc.	N = 120 BMI 30‐50 kg/m²	26‐week weight loss: Quick start guide for dietary plan 5 MR (3347‐4184 kJ (800‐1000 kcal)/day) plus 1 self‐selected meal of conventional food. Online access to resources, dietician trainers, message boards, chat rooms. 26‐week weight maintenance: Energy intake to achieve weight maintenance with the option to include 0‐3 MR a day.	26‐week weight loss: 4184 kJ (1000 kcal)/day mean plan based on self‐selected, self‐prepared conventional foods. Referral to the http://MyPyramid.gov website for nutritional information. Advised to take multivitamin supplement. 26‐week weight maintenance: Energy intake to achieve weight maintenance based on self‐selected conventional foods	Weight BMI Waist circumference Fat mass Fat‐free mass Systolic BP Glucose Total cholesterol LDL cholesterol HDL cholesterol Triglycerides Diastolic BP	MR: 83% Control: 75%
MR diet + enhanced support vs diet + support
Rock 2010	USA	Jenny Craig Inc.	N = 442 BMI >25 kg/m² Minimum 15 kg overweight 100% Female	2‐year weight loss: Weekly contacts for up to 2 years. Meal plan consisting of low‐fat reduced energy diet, with prepackaged foods providing up to 70% energy requirements, with remainder from self‐selected conventional foods. Group was split into 2 groups: Telephone advice: Counselling provided over the telephone or via email In‐person advice: Counselling provided face‐to face	2‐year weight loss: Consultation with a research dietetic professional at baseline and 6 months. Provided with print material describing dietary and physical activity guidelines to promote weight loss.	Weight BMI Waist circumference Total cholesterol LDL cholesterol HDL cholesterol Triglycerides	MR (in person): 99% MR (telephone): 100% Control: 98%
Rock 2014	USA	Jenny Craig Inc.	N = 70 BMI 25‐40 kg/m² Minimum 15 kg overweight 100% F	9‐month weight loss: Months 1‐6: Three main meals and one to two snack MR provided for 7 days/week Months 7‐9: Three main meals and one to two snack MR provided for And for 5 days/week 3‐month weight maintenance: One main meal and one snack MR provided each day for use as desired. Weekly consultations with train counsellors were recommended during the first 9 months after which participants had the option to move to biweekly or monthly consultations.	1‐year weight loss: Consultation at baseline and at 6 months with a research dietician who provided print materials on dietary and physical activity guidelines for weight loss and weight loss maintenance	Weight BMI Waist circumference Total cholesterol LDL cholesterol HDL cholesterol Triglycerides Insulin	MR: 91% Control: 94%
MR diet + support vs minimal intervention
Kempf 2017	Germany	Almased	N = 409 BMI ≥27 kg/m² Poorly controlled type 2 diabetes (HbA1c ≥ 7.5%) 42% Female	52 weeks: MR (stringent use of MR): Week 1: Replace 3 meals/day with MR and include 45 g oil rich omega 3 fatty acids and 750 mL vegetable juice. Weeks 2‐4: Replace 2 meals/day with MR and low‐carb other meals Weeks 5‐52: Replace 1 meal/day with MR MR (moderate use of MR): Week 1: Replace 2 meals/day with MR and include 45 g oil rich omega 3 fatty acids and 750 mL vegetable juice. Weeks 2‐4: Replace 2 meals/day with MR and low‐carb other meals Weeks 5‐52: Replace 1 meal/day with MR	Usual care: Quarterly visits with physician for routine care as defined by the disease management programs (DMP) for type 2 diabetes in Germany.	Weight (kg) Blood glucose Total cholesterol LDL cholesterol HDL cholesterol Triglycerides Systolic blood pressure Diastolic blood pressure	MR (stringent):69% MR (moderate):70% Control:74%
Look Ahead Research Group 2007	USA	NIH	N = 5145 BMI >25 kg/m² (BMI >27 kg/m² if taking insulin) Type 2 diabetic 60% F	1‐year weight loss: Months 1‐6: weekly session plus 3 group sessions per month Months 7‐12: biweekly group sessions plus one individual session. All sessions comprised of advice and support from dieticians, registered psychologists and exercise specialists to encourage >10% weight loss from initial body weight.	Diabetes support and education: Diabetes education session and invited to attend 3 additional group sessions during the 1^st year.	Weight BMI Waist circumference HbA1c LDL cholesterol HDL cholesterol Triglycerides Systolic blood pressure Diastolic blood pressure	MR: 97% Control: 96%
Xu 2013	China	The Science and Technology Commission of Shanghai Municipality (07ZR14036) and the Public Health Bureau of Shanghai (2007168)	N = 88 BMI >18.5 kg/m² Impaired glucose regulation 52% F	12‐week weight loss: Educational lecture on balanced diet, regular exercise, and behavioural strategies. Encouraged to follow the “2007 Chinese guidelines for the management of type 2 diabetes” and “Dietary Guidelines for Chinese” Weekly intensive lifestyle meetings and weekly medical evaluation by a physician.	Educational lecture: Educational lecture on balanced diet, regular exercise, and behavioural strategies. Encouraged to follow the “2007 Chinese guidelines for the management of type 2 diabetes” and “Dietary Guidelines for Chinese”	Weight BMI Waist circumference Total cholesterol HDL cholesterol LDL cholesterol Triglycerides Fasting plasma glucose HbA1c Systolic blood pressure Diastolic blood pressure	MR: 89% Control: 95%

Study ID

Location

Funder

Population

Intervention

Comparator

Relevant Outcomes

Follow‐Up Rate

MR diet vs diet only

Ahrens 2003

USA

SlimFast

N = 95

BMI >25 kg/m²

87% Female

12‐week weight loss:

Replace 2 of 3 meals with a liquid MR plus one self‐selected meal of conventional foods

10‐week weight maintenance:

1 MR and 2 self‐selected meals of conventional foods

12‐week weight loss:

Self‐selected diet, based on diabetic exchange ~5021 kJ (1200 kcal)/day for women, 6276 kJ (1500 kcal)/day for men

10‐week weight maintenance:

Healthy self‐selected diet and control of energy intake as desired

Weight

BMI

20%

(Not reported by group)

Cheskin 2008

USA

Medifast Inc.

N = 119

BMI 25‐40 kg/m²

Type 2 diabetes

56% Female

34‐week weight loss:

25% energy deficit diet with 50%‐60% energy provided by MR suitable for diabetics, the remainder provided by self‐selected conventional foods.

52‐week weight maintenance:

Rerandomized to either 26‐week MR followed by 26‐week control intervention, or 26‐week control intervention followed by 26‐week MR.

34‐week weight loss:

25% energy‐deficit diet ADA recommendations

52‐week maintenance: Continued at a lower energy restriction for maintenance

Weight

BMI

Body fat (%)

Waist circumference

Fasting glucose

Insulin

Total cholesterol

Systolic blood pressure

Diastolic blood pressure

Triglycerides

HbA1C

Medication use

MR: 57%

Control: 29%

Ditschuneit 2001

Germany

SlimFast

N = 100

BMI 25‐40 kg/m²

79% Female

3‐month weight loss:

2 MR + regular meal

48‐month weight maintenance:

Replace 1 meal and 1 snack with MR.

3‐month weight loss:

Low‐energy diet of conventional foods providing 5021 to 6276 kJ (1200 to 1500 kcal)/day. Three meals (breakfast, lunch, and dinner) and two snacks were recommended.

48‐month weight maintenance:

Replace 1 meal and 1 snack with MR.

Weight

Waist circumference

Fasting glucose

Insulin

Total cholesterol

LDL cholesterol

Systolic blood pressure

Diastolic blood pressure

MR 84%

Control: 72%

Khoo 2011

Australia

National Heart Foundation Australia and Medical Benefits Foundation

N = 31

BMI >30 kg/m²

WC >102 cm

Type 2 diabetes

0% Female

52‐week weight loss:

8 weeks:

Energy deficit

2 MR + small meal of self‐selected conventional foods.

44 weeks:

Switched to the control diet

52‐week weight loss:

High protein ~2510 kJ (600 kcal) energy‐deficit diet

Based on the Commonwealth Scientific Industrial and Research Organisation (CSIRO) total well‐being diet

Weight

Waist circumference

Plasma glucose

Insulin

Triglycerides

LDL cholesterol

HDL cholesterol

MR: 47%

Control: 58%

Khoo 2013

Singapore

The SingHealth Foundation and Changi General Hospital

N = 48

BMI >27.5 kg/m²

Men with erectile dysfunction

0% Female

12‐week weight loss:

~1674 kJ (400 kcal) energy deficit comprising 2 liquid MR + self‐selected meal

12‐week weight loss:

Conventional diet ~1674 kJ (400 kcal) energy deficit

Weight

BMI

Waist circumference

Body fat (%)

Plasma glucose

Plasma insulin

Systolic blood pressure

Diastolic blood pressure

MR: 58%

Control: 54%

Rothacker 2001

USA

Maryland Chapter of the Arthritis Foundation

N = 75

BMI 25‐32 kg/m²

100% Female

1‐year weight loss:

Replace 1 or more meals with liquid MR

1‐year weight loss:

Low‐energy low‐fat diet of ~5021 kJ (1200 kcal)/day

Weight

Fat mass

Lean body mass

Fat (%)

MR: 84%

Control: 87%

MR diet + support vs diet + support

Ashley 2001

USA

Slim fast

N = 113

BMI 25‐50 kg/m²

Premenopausal women

100% Female

1‐year weight loss:

MR (dietician led):

Small classes (8‐10 participants per class)

Weekly for the first 3 months, biweekly for the next 3 months and monthly for the final 6 months.

Diet consisting of replacing 2 of the 3 main meals (breakfast, lunch, or dinner) with MR shakes or bars.

MR physician/nurse led:

Brief (10/15 min) biweekly visits with a physician or nurse. Diet consisting of replacing 2 of the 3 main meals (breakfast, lunch, or dinner) with MR shakes or bars.

1‐year weight loss:

Small dietician‐led classes (8‐10 participants per class)

Weekly for the first 3 months, biweekly for the next 3 months and monthly for the final 6 months. All meals and snacks prepared from self‐selected conventional foods ~5021 kJ (1200 kcal)/day using the US Department of Agriculture food guide pyramid.

Weight

Waist circumference

Body fat (skinfold)

Glucose

Insulin

Total cholesterol

LDL cholesterol

HDL cholesterol

Triglycerides

Systolic blood pressure

Diastolic blood pressure

65% overall (not reported by group)

Ashley 2007

USA

SlimFast/Unilever

N = 96

BMI 25‐35 kg/m²

100% Female

1‐year weight loss:

Replace 2 of 3 main meals with MR drinks or bars.

Bimonthly classes for 6 months followed by monthly classes for 6 months.

1‐year weight loss:

Diet plan based of ~5021 kJ (1200 kcal)/day based on self‐selection of conventional foods for meals and snacks using the USDA food guide pyramid.

Bimonthly classes of 6 months followed by monthly classes for a further 6 months

Weight (kg)

BMI

Body fat (%)

Waist circumference

MR: 73%

Control: 73%

Chaiyasoot 2018

Thailand

Slimwell

N = 110

BMI >25

Metabolic syndrome

83% Female

12 weeks:

Replace 2 main meals with one MR for the duration of the 12 week intervention.

Group session at baseline followed by 4 individual sessions with dietician.

12 weeks:

Baseline group session and 4 individual sessions with dietitian who advised an energy restriction diet based on ~2092‐4184 kJ (500‐100 kcal)/day energy restriction.

Weight (kg)

MR: 72%

Control:84%

Chee 2017

Malaysia

Abbott Nutrition Malaysia

N = 230

BMI >23 kg/m²

Type 2 diabetes

63% Female

6 months

MR (MI):

Replace 1 or 2 meals with a diabetes‐specific formula meal replacement. Behavioural support provided using motivational interview.

MR (CC):

Replace 1 or 2 meals with a diabetes‐specific formula meal replacement.

Behavioural support provided using conventional counselling.

6 months:

Followed the clinical care pathway of the Malaysian clinical practice guidelines for type 2 diabetes mellitus (2009) and received advice to follow a conventional low‐calorie diet plan 5021 kJ (1200 kcal) or 6276 kJ (1500 kcal)/day using normal foods with standard diabetes support and lifestyle education.

Weight (kg)

MR (MI): 88%

MR (CC): 70%

Control: 85%

Davis 2010

USA

Medifast Inc.

N = 90

BMI 30‐50 kg/m²

71% Female

16‐week weight loss:

5 MR + a self‐selected meal. Biweekly consultations with a dietician for dietary and behavioural counselling.

24‐week weight maintenance:

2 meetings with dietician at 12‐week intervals.

16‐week weight loss: ~4184 kJ (1000 kcal)/day diet plan plus multivitamin supplement. Biweekly consultations with a dietician for dietary and behavioural counselling.

24‐week weight maintenance:

2 meetings with dietician at 12‐week intervals.

Weight (kg)

Waist circumference

Body fat (%)

Total cholesterol

HDL cholesterol

LDL cholesterol

Triglycerides

Systolic BP

Diastolic BP

MR: 58%

Control: 44%

Flechtner‐Mors 2010

Germany

University of Ulm and Herbalife Inc.

N = 100

Overweight and obese

(BMI 27‐45 kg/m²), metabolic syndrome

80% Female

3‐month weight loss:

Diet instructions to follow diet high protein with energy deficit of ~2092 kJ (500 kcal)/day based on consuming

2 protein‐enriched MR plus one conventional meal and 2 snacks.

9‐month weight maintenance:

1 MR two conventional meals and two snacks

3‐month weight loss:

Diet instructions to follow diet with conventional protein content with energy deficit of ~2092 kJ (500 kcal)/day, 3 conventional meals 2 snacks

9‐month weight maintenance:

2 conventional meals 2 conventional snacks and 1 MR

Weight

BMI

Body fat (%)

Blood glucose

Insulin

HbA1c

Total cholesterol

HDL cholesterol

Triglycerides

Adverse events

MR: 56%

Control: 78%

Li 2005

USA

Not disclosed‐meal replacements provided by SlimFast foods Co. Inc.

N = 104

BMI 27‐40 kg/m²

Type 2 diabetics

62% Female

1 year:

Individual consultation with a dietician at baseline and weekly for 2 months, then monthly for the remainder

First 5 days: 3 soy MR and advice to add fruits and vegetables to their intake

Day 6‐3 months: 2 MR plus one meal of self‐selected foods

3 months‐1 year: 1 or 2 MR plus 2 sensible meals.

1 year:

Individual consultation with a dietician at baseline and weekly for 2 months, then monthly for the remainder.

Individualized meal plan based on ADA exchanges, target reduction in intake of ~2092 kJ (500 kcal)/day.

Weight

BMI

Glucose

Insulin

HbA1c

Total cholesterol

LDL cholesterol

HDL cholesterol

Triglycerides

MR: 81%

Control: 67%

Lowe 2018

USA

National Institutes of Health (NIH)

N = 181

BMI 27‐45 kg/m²

84% Female

1 year:

Weekly groups for 6 mo, then biweekly for 6 mo. During months 1‐6 participants were advised to replace 2 meals with MR product. In months 7‐12 switched to replacing 1 meal and 1 snack with MR product.

1 year:

Weekly groups for 6 mo, then biweekly for 6 mo. Following materials from lifestyle, exercise, attitude relationships and nutrition (LEARN) and diabetes prevention program manual. Focus on weight loss months 1‐6 and weight maintenance months 7‐12.

Weight (kg)

MR: 73%

Control: 81%

Ptomey 2017

USA

National Institutes of Diabetes, Digestive and Kidney Diseases (NIDDK)

N = 150

BMI >25 kg/m²

Intellectual developmental disabilities

57% Female

18‐month weight loss:

Participants and study partners taught how to prepare and consume 2 portion‐controlled main meal MR and 2 MR shakes a day with additional meal of self‐selected conventional foods according to a guide. Health educators conducted monthly home visits.

18‐month weight loss:

Participants and study partners taught how to follow a 2092‐2929 kJ (500‐700 kcal)/day energy deficit diet following Myplate approach. Health educators conducted monthly home visits.

Weight

BMI

Waist circumference

MR: 69%

Control: 65%

Rolls 2017

USA

National Institutes of Diabetes, Digestive and Kidney Diseases (NIDDK)

N = 124

BMI 28‐45 kg/m²

100% Female

1‐year weight loss:

Participants met individually with a dietician for 19 sessions. They were instructed to eat preportioned main dishes daily for lunch and dinner during months 1‐3 of the study and were encouraged to continue this practice subsequently.

1‐year weight loss:

Participants met individually with a dietician for 19 sessions. Instructed to follow US dietary guidelines emphasizing eating less whilst making healthy choices from all food groups.

Weight

Glucose

HbA1c

Total cholesterol

LDL cholesterol

HDL cholesterol

Triglycerides

Systolic blood pressure

Diastolic blood pressure

MR: 82%

Control:82%

MR diet + support vs diet only

Rock 2007

USA

Jenny Craig Inc.

N = 70

BMI 25‐40 kg/m²

Minimum 15 kg overweight

100% F

12‐month weight loss:

Weekly one‐to‐one contacts with a counsellor, with follow‐up telephone and e‐mail contacts and web site/message board availability. Energy reduced diet with prepackaged prepared foods typically providing 3347 kJ (800 kcal)/day, with the remainder provided by self‐selected conventional food.

A goal is 30 minutes of physical activity on 5 or more days of the week.

1‐year weight loss:

Consultation with a dietician at baseline and 16 weeks who provided a diet and physical activity plan to promote weight loss.

Weight

BMI

Waist circumference

Hip circumference

Insulin

Total cholesterol

LDL cholesterol

HDL cholesterol

Triglycerides

MR: 91%

Control: 94%

Shikany 2013

USA

Medifast Inc.

N = 120

BMI 30‐50 kg/m²

26‐week weight loss:

Quick start guide for dietary plan

5 MR (3347‐4184 kJ (800‐1000 kcal)/day) plus 1 self‐selected meal of conventional food. Online access to resources, dietician trainers, message boards, chat rooms.

26‐week weight maintenance:

Energy intake to achieve weight maintenance with the option to include 0‐3 MR a day.

26‐week weight loss:

4184 kJ (1000 kcal)/day mean plan based on self‐selected, self‐prepared conventional foods. Referral to the http://MyPyramid.gov website for nutritional information. Advised to take multivitamin supplement.

26‐week weight maintenance:

Energy intake to achieve weight maintenance based on self‐selected conventional foods

Weight

BMI

Waist circumference

Fat mass

Fat‐free mass

Systolic BP

Glucose

Total cholesterol

LDL cholesterol

HDL cholesterol

Triglycerides

Diastolic BP

MR: 83%

Control: 75%

MR diet + enhanced support vs diet + support

Rock 2010

USA

Jenny Craig Inc.

N = 442

BMI >25 kg/m²

Minimum 15 kg overweight

100% Female

2‐year weight loss:

Weekly contacts for up to 2 years. Meal plan consisting of low‐fat reduced energy diet, with prepackaged foods providing up to 70% energy requirements, with remainder from self‐selected conventional foods.

Group was split into 2 groups:

Telephone advice:

Counselling provided over the telephone or via email

In‐person advice:

Counselling provided face‐to face

2‐year weight loss:

Consultation with a research dietetic professional at baseline and 6 months. Provided with print material describing dietary and physical activity guidelines to promote weight loss.

Weight

BMI

Waist circumference

Total cholesterol

LDL cholesterol

HDL cholesterol

Triglycerides

MR (in person): 99%

MR (telephone): 100%

Control: 98%

Rock 2014

USA

Jenny Craig Inc.

N = 70

BMI 25‐40 kg/m²

Minimum 15 kg overweight

100% F

9‐month weight loss:

Months 1‐6: Three main meals and one to two snack MR provided for 7 days/week

Months 7‐9: Three main meals and one to two snack MR provided for

And for 5 days/week

3‐month weight maintenance:

One main meal and one snack MR provided each day for use as desired.

Weekly consultations with train counsellors were recommended during the first 9 months after which participants had the option to move to biweekly or monthly consultations.

1‐year weight loss:

Consultation at baseline and at 6 months with a research dietician who provided print materials on dietary and physical activity guidelines for weight loss and weight loss maintenance

Weight

BMI

Waist circumference

Total cholesterol

LDL cholesterol

HDL cholesterol

Triglycerides

Insulin

MR: 91%

Control: 94%

MR diet + support vs minimal intervention

Kempf 2017

Germany

Almased

N = 409

BMI ≥27 kg/m²

Poorly controlled type 2 diabetes (HbA1c ≥ 7.5%)

42% Female

52 weeks:

MR (stringent use of MR):

Week 1: Replace 3 meals/day with MR and include 45 g oil rich omega 3 fatty acids and 750 mL vegetable juice.

Weeks 2‐4: Replace 2 meals/day with MR and low‐carb other meals

Weeks 5‐52: Replace 1 meal/day with MR

MR (moderate use of MR):

Week 1: Replace 2 meals/day with MR and include 45 g oil rich omega 3 fatty acids and 750 mL vegetable juice.

Weeks 2‐4: Replace 2 meals/day with MR and low‐carb other meals

Weeks 5‐52: Replace 1 meal/day with MR

Usual care:

Quarterly visits with physician for routine care as defined by the disease management programs (DMP) for type 2 diabetes in Germany.

Weight (kg)

Blood glucose

Total cholesterol

LDL cholesterol

HDL cholesterol

Triglycerides

Systolic blood pressure

Diastolic blood pressure

MR (stringent):69%

MR (moderate):70%

Control:74%

Look Ahead Research Group 2007

USA

NIH

N = 5145

BMI >25 kg/m²

(BMI >27 kg/m² if taking insulin)

Type 2 diabetic

60% F

1‐year weight loss:

Months 1‐6: weekly session plus 3 group sessions per month

Months 7‐12: biweekly group sessions plus one individual session.

All sessions comprised of advice and support from dieticians, registered psychologists and exercise specialists to encourage >10% weight loss from initial body weight.

Diabetes support and education:

Diabetes education session and invited to attend 3 additional group sessions during the 1^st year.

Weight

BMI

Waist circumference

HbA1c

LDL cholesterol

HDL cholesterol

Triglycerides

Systolic blood pressure

Diastolic blood pressure

MR: 97%

Control: 96%

Xu 2013

China

The Science and Technology Commission of Shanghai Municipality (07ZR14036) and the Public Health Bureau of Shanghai (2007168)

N = 88

BMI >18.5 kg/m²

Impaired glucose regulation

52% F

12‐week weight loss:

Educational lecture on balanced diet, regular exercise, and behavioural strategies. Encouraged to follow the “2007 Chinese guidelines for the management of type 2 diabetes” and “Dietary Guidelines for Chinese”

Weekly intensive lifestyle meetings and weekly medical evaluation by a physician.

Educational lecture:

Educational lecture on balanced diet, regular exercise, and behavioural strategies.

Encouraged to follow the “2007 Chinese guidelines for the management of type 2 diabetes” and “Dietary Guidelines for Chinese”

Weight

BMI

Waist circumference

Total cholesterol HDL cholesterol

LDL cholesterol

Triglycerides

Fasting plasma glucose

HbA1c

Systolic blood pressure

Diastolic blood pressure

MR: 89%

Control: 95%