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

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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Sarcopenic Obesity
• Intervention / Treatment: Other: Protein supplemented very low calorie diet program; Other: Conventional low calorie diet program

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 Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ju Young Kim, MD, PhD; Phone Number: (82)1036964218; Email: kkamduri@snubh.org

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in weight	Changes of weight loss from the baseline expressed as kg	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Changes in systolic and diastolic blood pressure	Changes in systolic and diastolic blood pressure from the baseline expressed as mmHg	12 months
Changes in triglyceride	Changes in triglyceride from the baseline expressed as mg/dL	12 months
Changes in glucose	Changes in glucose from the baseline expressed as mg/dL	12 months
Changes in high density lipoprotein (HDL) Cholesterol	Changes in HDL cholesterol from the baseline expressed as mg/dL	12 months
Changes in low density lipoprotein (LDL) Cholesterol	Changes in LDL cholesterol from the baseline expressed as mg/dL	12 months
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
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
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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): November 16, 2020
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): January 31, 2023

Study Registration Dates

• First Submitted: September 3, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 15, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: B-2004-604-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No