Promotion of Weight Management
- Conditions
- Overweight
- Interventions
- Other: Weight MaintenanceOther: Weight Maintenance + Intermittent Fasting
- Registration Number
- NCT04131647
- Lead Sponsor
- VA Office of Research and Development
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 175
- Veteran
- 50-75 years of age
- BMI: 25-40 kg/m2
- Postmenopausal status for women
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Weight Maintenance Weight Maintenance Heart Healthy nutrition, walking, resistance band exercise Weight Maintenance + Intermittent Fasting 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.
- Primary Outcome Measures
Name Time Method Change in Body Weight Baseline, after 12 weeks of weight loss+exercise, at 36-week weight maintenance, and 48-week follow-up weight in kg
- Secondary Outcome Measures
Name Time Method Change in Gait Speed 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
Change in body fat Baseline, after 12 weeks of weight loss+exercise, and at 36-week weight maintenance abdominal fat area, in cm2
Change in LPL Baseline, after 12 weeks of weight loss+exercise, and at 36-week weight maintenance skeletal muscle lipoprotein lipase in nmol/min/ mg protein
Trial Locations
- Locations (2)
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, United States