Efficacy of Protein Supplemented Very Low Calorie Meals on Weight Loss

NCT04597788 | Unknown

• 1 other identifier: B-2004-604-003
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Sarcopenic Obesity

Outcome Measures

Primary Outcomes (1)

• Changes in weight

  Changes of weight loss from the baseline expressed as kg

  12 months

Secondary Outcomes (9)

• Changes in body composition

  12 months

• Changes in systolic and diastolic blood pressure

  12 months

• Changes in triglyceride

  12 months

• Changes in glucose

  12 months

• Changes in high density lipoprotein (HDL) Cholesterol

  12 months

Study Arms (2)

Protein supplemented very low calorie diet program

EXPERIMENTAL

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

Conventional low calorie diet program

ACTIVE COMPARATOR

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

Interventions

Protein supplemented very low calorie diet program OTHER

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.

Protein supplemented very low calorie diet program

Conventional low calorie diet program OTHER

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.

Conventional low calorie diet program

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body Mass Index (BMI ) more than 25 kg/m2 or
• Waist circumference more than 90 cm in men or 85 cm in women

You may not qualify if:

• 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)

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Seoul National University Bundang Hospital: collaborator

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Related Publications (1)

• Cho E, Kim S, Kim HJ, Cho B, Park JH, Kwon H, Kim JY, Go Y, Kang DG, Shin E, Lee S, Gil S, Kim H, Ahn J, Kim JY, Jung W, Go E. Effectiveness of a protein-supplemented very-low-calorie diet program for weight loss: a randomized controlled trial in South Korea. Front Nutr. 2024 Sep 12;11:1370737. doi: 10.3389/fnut.2024.1370737. eCollection 2024.

  PMID: 39328464 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ju Young Kim, MD, PhD

CONTACT

(82)1036964218; kkamduri@snubh.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: October 22, 2020
• Study Start: November 16, 2020
• Primary Completion: December 1, 2022
• Study Completion: January 31, 2023
• Last Updated: October 22, 2020

Record last verified: 2020-07

Locations

KR (1)