Promotion of Weight Management

Study Overview
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Brief Summary
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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
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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.

Official Title
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Promotion of Successful Weight Management in Overweight and Obese Veterans

Conditions
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Overweight

Intervention / Treatment
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* Other: Weight Maintenance
* Other: Weight Maintenance + Intermittent Fasting


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Weight management program
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Weight Maintenance<br>Heart Healthy nutrition, walking, resistance band exercise | Other: Weight Maintenance<br>* 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<br>|
| Experimental: Weight Maintenance + Intermittent Fasting<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Diet, Obesity