Promotion of Weight Management

Overweight Clinical Trial

— POWER-VET  

Official title:

Promotion of Successful Weight Management in Overweight and Obese Veterans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04131647
• Other study ID #: ENDA-013-19S
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: January 7, 2026

Study information

• Verified date: November 2023
• Source: VA Office of Research and Development
• Contact: Alice S Ryan, PhD
• Phone: (410) 605-7851
• Email: Alice.Ryan[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The identification of intermittent fasting as an alternative method to traditional weight maintenance protocols could have a significant impact on preventing body weight regain common after successful weight loss, and potentially lead to a reduction in pharmaceutical and clinical costs related to the care of overweight and obese adults.

Description:

The research will examine the impact of intermittent fasting to promote long term body weight maintenance following successful weight loss in overweight and obese Veterans. This research is especially relevant to the majority of Veterans who struggle with obesity and maintaining weight loss. Obesity increases the risk for storing excess calories in ectopic depots, including skeletal muscle. Intramuscular fat is related to altered substrate utilization (metabolic inflexibility) and defects in insulin sensitivity, ultimately leading to type 2 diabetes mellitus and cardiovascular disease. The objective of this proposal is to test in a randomized clinical trial the effectiveness of an intensive weight management program with and without intermittent fasting (IF) to combat weight regain and the obesity crisis in our Veterans. Further, this application proposes to examine the role of several enzymes involved in skeletal muscle fatty acid oxidation as a mechanism for efficacious long term weight management.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 7, 2026
• Est. primary completion date: July 5, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• Veteran

• 50-75 years of age

• BMI: 25-40 kg/m2

• Postmenopausal status for women

Exclusion Criteria:

• Uncontrolled diabetes (HbA1c >10% or the current use of insulin)

• Neurologic, musculoskeletal, or other condition that limits subject's ability to complete study physical assessments

• Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignant, and psychiatric disease

• Weight change within the past month of >5 kg

• Self-reported alcohol or drug abuse

• Anti-coagulant medication for muscle biopsies only Impaired renal function (creatinine > 1.5 mg/dl) History or evidence of serious liver disease (LFTs > 2.5 x WNL)

Related Conditions & MeSH terms

• Overweight

Intervention

Other:
• Weight Maintenance
Following a 12-week weight loss and exercise program, subjects will participate in a weight maintenance program of Heart Healthy nutrition, walking, and resistance band exercise
• Weight Maintenance + Intermittent Fasting
Following a 12-week weight loss and exercise program, subjects will participate in a weight maintenance program of Heart Healthy nutrition, walking, resistance band exercise and intermittent fasting (2 small meals per day) one day per week for 24 weeks.

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Baltimore	Maryland
United States	South Texas Health Care System, San Antonio, TX	San Antonio	Texas

Sponsors (3)

Lead Sponsor	Collaborator
VA Office of Research and Development	Baltimore VA Medical Center, South Texas Veterans Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Weight	weight in kg	Baseline, after 12 weeks of weight loss+exercise, at 36-week weight maintenance, and 48-week follow-up
Secondary	Change in Gait Speed	Fastest comfortable walking speed over 4 meters. Units are m/sec	Baseline, after 12 weeks of weight loss+exercise, at 36-week weight maintenance, and 48-week follow-up
Secondary	Change in body fat	abdominal fat area, in cm2	Baseline, after 12 weeks of weight loss+exercise, and at 36-week weight maintenance
Secondary	Change in LPL	skeletal muscle lipoprotein lipase in nmol/min/ mg protein	Baseline, after 12 weeks of weight loss+exercise, and at 36-week weight maintenance