Efficacy of Protein Supplemented Very Low Calorie Meals on Weight Loss

Not Applicable

• Conditions: Obesity; Sarcopenic Obesity
• Interventions: Other: Protein supplemented very low calorie diet program; Other: Conventional low calorie diet program

• Registration Number: NCT04597788
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-09-03
• Study First Submitted QC: 2020-10-15
• Last Update Submitted: 2020-10-15
• Study First Posted: 2020-10-22
• Last Update Posted: 2020-10-22
• Study Start: 2020-11-16
• Primary Completion: 2022-12-01
• Study Completion: 2023-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 104

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Protein supplemented very low calorie diet program	Protein supplemented very low calorie diet program	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.
Conventional low calorie diet program	Conventional low calorie diet program	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.

Primary Outcome Measures

Name	Time	Method
Changes in weight	12 months	Changes of weight loss from the baseline expressed as kg

Secondary Outcome Measures

Name	Time	Method
Changes in systolic and diastolic blood pressure	12 months	Changes in systolic and diastolic blood pressure from the baseline expressed as mmHg
Changes in glucose	12 months	Changes in glucose from the baseline expressed as mg/dL
Changes in triglyceride	12 months	Changes in triglyceride from the baseline expressed as mg/dL
Changes in high density lipoprotein (HDL) Cholesterol	12 months	Changes in HDL cholesterol from the baseline expressed as mg/dL
Changes in body composition	12 months	Changes in muscle mass and fat mass from the baseline expressed as kg using bioelectrial impedance analysis (Inbody Co., Seoul, Korea)
Changes in liver enzyme	12 months	Changes in aspartate and alanine aminotransferase, gamma glutamyltransferase (AST and ALT, GGT) from the baseline expressed as IU/L
Changes in insulin resistance	12 months	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
Changes in low density lipoprotein (LDL) Cholesterol	12 months	Changes in LDL cholesterol from the baseline expressed as mg/dL
Changes in obesity related quality of life	12 months	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 )

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of