Efficacy of Protein Supplemented Very Low Calorie Meals on Weight Loss
- Conditions
- ObesitySarcopenic Obesity
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 104
- Body Mass Index (BMI ) more than 25 kg/m2 or
- Waist circumference more than 90 cm in men or 85 cm in women
- 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
- 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
Seoul National University Bundang Hospital🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of