Efficacy of Protein Supplemented Very Low Calorie Meals on Weight Loss

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04597788
• Other study ID #: B-2004-604-003
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 16, 2020
• Est. completion date: January 31, 2023

Study information

• Verified date: July 2020
• Source: Seoul National University Hospital
• Contact: Ju Young Kim, MD, PhD
• Phone: (82)1036964218
• Email: kkamduri[@]snubh.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 104
• Est. completion date: January 31, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obesity
• Sarcopenic Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in weight	Changes of weight loss from the baseline expressed as kg	12 months
Secondary	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
Secondary	Changes in systolic and diastolic blood pressure	Changes in systolic and diastolic blood pressure from the baseline expressed as mmHg	12 months
Secondary	Changes in triglyceride	Changes in triglyceride from the baseline expressed as mg/dL	12 months
Secondary	Changes in glucose	Changes in glucose from the baseline expressed as mg/dL	12 months
Secondary	Changes in high density lipoprotein (HDL) Cholesterol	Changes in HDL cholesterol from the baseline expressed as mg/dL	12 months
Secondary	Changes in low density lipoprotein (LDL) Cholesterol	Changes in LDL cholesterol from the baseline expressed as mg/dL	12 months
Secondary	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
Secondary	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
Secondary	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