Efficacy of Protein Supplemented Very Low Calorie Meals on Weight Loss

Study Overview
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Brief Summary
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This randomized clinical trial will evaluate the efficacy and safety of protein supplemented very low calorie meals on weight loss and weight loss maintenance among people with obesity.

Detailed Description
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Approximately 30% of the Korean population has obesity or abdominal obesity and is often accompanied by obesity related complications such as cardiovascular disease, diabetes, osteoarthritis and even some types of cancer. However, there are not many lifestyle modification treatments available that have long-term effects other than drugs and surgical treatments in the management of obesity. Preserving muscle mass should also be considered in weight loss especially for elderly adults with obesity, because decreased muscle mass and strength can negatively affect morbidity and mortality in the elderly. Therefore, the investigators want to evaluate the effectiveness and safety of the protein supplemented very low calorie meals on weight loss, body composition as well as metabolic changes compared with traditional low calorie low fat diet in people with obesity.

Official Title
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The Role of Protein Supplemented Very Low Calorie Medical Meals on Weight and Metabolic Changes Among People With Obesity: a Randomized Controlled Trial

Conditions
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Obesity, Sarcopenic Obesity

Intervention / Treatment
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* Other: Protein supplemented very low calorie diet program
* Other: Conventional low calorie diet program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body Mass Index (BMI ) more than 25 kg/m2 or Waist circumference more than 90 cm in men or 85 cm in women Exclusion Criteria: History of treatment with anti-obesity drugs or participation in another weight loss program in previous 6 months Weight changes more than 3 kg during the 6 months before participation Unstable cardiovascular events during the 6 months before participation Uncontrolled mood disorder History of eating disorder History of alcohol use disorder History of gallstone Chronic renal failure (estimated glomerular filtration less than 30 ml/min)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Protein supplemented very low calorie diet program<br>The lifestyle intervention using protein supplemented very low calorie meals will be implemented with individual counseling sessions for 12 months. Initial intensive weight loss stage will be delivered during the first 4 month period with total meal replacement to partial meal replacement using protein supplemented very low calorie meals. During the weight loss maintenance stage, regular intermittent very low calorie meal replacement one week per month will be delivered for the entire period. Mobile counseling will be offered to help patients achieve weight loss as well as weight loss maintenance. | Other: Protein supplemented very low calorie diet program<br>* Protein supplemented very low calorie meal is a shake-type meal replacement with total calories of 600 to 800 calories per day and proteins provided at 1.2g of ideal body weight per day. The four-month, very low calorie diet program schedule will be as follows. In the first two weeks, all three meals are replaced, followed by two meals replaced and one meal in food in the next six weeks, and one meal replacement is recommended for the next eight weeks. For the next eight months, the intermittent very low calorie meal replacements will be provided regularly for one week a month. If a subject gains weight more than 2kg, he or she will have an additional 1 week of two meal replacements, and if a subject gains weight more than 4kg, he or she should have an additional 2 weeks of replacement. Individual sessions will be held 11 times during the study. Mobile counseling with dietitians or nurses will be offered to help subjects lose weight and maintain weight loss.<br>|
| Active Comparator: Conventional low calorie diet program<br>The conventional low calorie diet program will be offered to participants assigned to control group using educational material and individual counseling sessions for 12 months. Mobile counseling will be also offered for weight loss and weight loss maintenance. | Other: Conventional low calorie diet program<br>* Low calorie diet consists of 1200 to 1500 calories will be educated and lifestyle modification will be encouraged for participants in control group. Educational materials as well as recipes for low calorie diet will be provided in individual sessions. Mobile counseling will also be offered for sticking to the diet program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in weight | Changes of weight loss from the baseline expressed as kg | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body composition | Changes in muscle mass and fat mass from the baseline expressed as kg using bioelectrial impedance analysis (Inbody Co., Seoul, Korea) | 12 months | 
| Changes in systolic and diastolic blood pressure | Changes in systolic and diastolic blood pressure from the baseline expressed as mmHg | 12 months | 
| Changes in triglyceride | Changes in triglyceride from the baseline expressed as mg/dL | 12 months | 
| Changes in glucose | Changes in glucose from the baseline expressed as mg/dL | 12 months | 
| Changes in high density lipoprotein (HDL) Cholesterol | Changes in HDL cholesterol from the baseline expressed as mg/dL | 12 months | 
| Changes in low density lipoprotein (LDL) Cholesterol | Changes in LDL cholesterol from the baseline expressed as mg/dL | 12 months | 
| Changes in liver enzyme | Changes in aspartate and alanine aminotransferase, gamma glutamyltransferase (AST and ALT, GGT) from the baseline expressed as IU/L | 12 months | 
| Changes in insulin resistance | Changes in insulin resistance using the homeostatic model assessment for insulin resistance (HOMA-IR) as HOMA-IR =insulin(uIU/ml) * fasting glucose (mg/dL)*0.05551/22.5 | 12 months | 
| Changes in obesity related quality of life | Changes in Korean version of obesity related quality of life scales (published in Korean Society for the Study of Obesity 2003;12(4):280-293 ) | 12 months |