NCT04597788

Efficacy of Protein Supplemented Very Low Calorie Meals on Weight Loss

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity
• Sarcopenic Obesity

Interventions

Type	Name	Description
OTHER	Protein supplemented very low calorie diet program	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.
OTHER	Conventional low calorie diet program	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.

Timeline

• Start date: 2020-11-16
• Primary completion: 2022-12-01
• Completion: 2023-01-31
• First posted: 2020-10-22
• Last updated: 2020-10-22

Locations

1 site across 1 country: South Korea