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OpenTrials
Active, Not Recruiting

NCT Number: NCT04131647

Promotion of Weight Management

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD, Baltimore, Maryland, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Weight Maintenance

Other

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

Other

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.

Primary outcomes

  1. Change in Body Weight

    Time frame: Baseline, after 12 weeks of weight loss+exercise, at 36-week weight maintenance, and 48-week follow-up

    weight in kg

Secondary outcomes

  1. Change in Gait Speed

    Time frame: Baseline, after 12 weeks of weight loss+exercise, at 36-week weight maintenance, and 48-week follow-up

    Fastest comfortable walking speed over 4 meters. Units are m/sec

  2. Change in body fat

    Time frame: Baseline, after 12 weeks of weight loss+exercise, and at 36-week weight maintenance

    abdominal fat area, in cm2

  3. Change in LPL

    Time frame: Baseline, after 12 weeks of weight loss+exercise, and at 36-week weight maintenance

    skeletal muscle lipoprotein lipase in nmol/min/ mg protein

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Baltimore VA Medical Center
  • South Texas Veterans Health Care System

Registry information

Official study title

Promotion of Successful Weight Management in Overweight and Obese Veterans

Acronym: POWER-VET

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Oct 18, 2019
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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