The Role of Protein Supplemented Very Low Calorie Medical Meals on Weight and Metabolic Changes Among People With Obesity: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- Changes in weight
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
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.
Intervention: Protein supplemented very low calorie diet program (Other)
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.
Intervention: Conventional low calorie diet program (Other)
Outcomes
Primary Outcomes
Changes in weight
Time Frame: 12 months
Changes of weight loss from the baseline expressed as kg
Secondary Outcomes
- Changes in systolic and diastolic blood pressure(12 months)
- Changes in glucose(12 months)
- Changes in triglyceride(12 months)
- Changes in high density lipoprotein (HDL) Cholesterol(12 months)
- Changes in body composition(12 months)
- Changes in liver enzyme(12 months)
- Changes in insulin resistance(12 months)
- Changes in low density lipoprotein (LDL) Cholesterol(12 months)
- Changes in obesity related quality of life(12 months)