Overweight
Conditions
Keywords
Exercise, Diet, Obesity
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.
Interventions
OTHERWeight 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
OTHERWeight 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.
Sponsors
Baltimore VA Medical Center
South Texas Veterans Health Care System
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Weight management program
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed