Promotion of Weight Management (POWER-VET)

Promotion of Successful Weight Management in Overweight and Obese Veterans

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.

Study Overview

• Status: Recruiting
• Conditions: Overweight
• Intervention / Treatment: Other: Weight Maintenance; Other: Weight Maintenance + Intermittent Fasting

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alice S Ryan, PhD; Phone Number: (410) 605-7851; Email: Alice.Ryan@va.gov
• Study Contact Backup: Name: Kristina Marcus, MS; Phone Number: (410) 605-7000; Email: kristina.marcus@va.gov

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
      • Contact: Lynda C Robey; Phone Number: 5446 410-605-7000; Email: lynda.robey@va.gov
      • Principal Investigator: Alice S. Ryan, PhD
  • Texas
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • South Texas Health Care System, San Antonio, TX
      • Contact: Monica Serra, PhD; Phone Number: 210-949-9759; Email: monica.serra@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Weight Maintenance; Heart Healthy nutrition, walking, resistance band exercise	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
Experimental: Weight Maintenance + Intermittent Fasting; Heart Healthy nutrition, walking, resistance band exercise and intermittent fasting (2 small meals per day) one day per week for 24 weeks.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in body fat	abdominal fat area, in cm2	Baseline, after 12 weeks of weight loss+exercise, and at 36-week weight maintenance
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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Baltimore VA Medical Center; South Texas Veterans Health Care System
• Investigators: Principal Investigator: Alice S. Ryan, PhD, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Estimated): July 5, 2025
• Study Completion (Estimated): January 7, 2026

Study Registration Dates

• First Submitted: October 16, 2019
• First Submitted That Met QC Criteria: October 16, 2019
• First Posted (Actual): October 18, 2019

Study Record Updates

• Last Update Posted (Estimated): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Exercise; Obesity; Diet
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight
• Other Study ID Numbers: ENDA-013-19S

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No