Calorie Restriction and Changes in Body Composition, Disease, Function, and Quality of Life in Older Adults
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 167
- Locations
- 2
- Primary Endpoint
- Change in Abdominal Fat Mass
Study Overview
Brief Summary
The investigators want to determine if the benefits of weight loss outweigh the potential risk in a group of older adults. The investigators will test the hypothesis that changes in diet composition alone or in conjunction with weight loss will have a significant effect on fat stores, and as a result, improve cardiometabolic risk factors and functional status in adults 65 and older.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •at least 65 years of age
- •BMI 27 - 42 kg/m2 - at increased health risk (taking at least 1 medication for hypertension, hyperlipidemia, or type 2 diabetes)
Exclusion Criteria
- •difficulties chewing or swallowing food
- •digestive diseases that may affect the ability to follow a high fiber diet
- •cognitive impairment
- •depression
- •recent weight change (+/- 10 lbs in the last 12 months)
- •poorly controlled blood pressure
- •history of non-skin cancer in last 5 years
- •cardiovascular disease event in past 6 months or severe pulmonary disease or renal failure
- •major liver dysfunction
- •current smoker or quit less than months prior
- •history of prior surgical procedures for weight control or liposuction
- •use of estrogen or testosterone replacement therapy
- •current use of insulin or sulfonylurea agents
- •current use of corticosteroids > 5 days/month on average
- •current use of medications for treatment of psychosis or manic-depressive illness
- •use of weight-loss medications in previous 3 months
- •dependence on others for food procurement or preparation
- •ischemic changes on exercise treadmill test
Arms & Interventions
Weight Loss
Participants receive Exercise and Reduced Calorie Diet Interventions
Intervention: Exercise (Behavioral)
Weight Loss
Participants receive Exercise and Reduced Calorie Diet Interventions
Intervention: Reduced Calorie Diet (Behavioral)
Control
Participants receive Exercise Intervention
Intervention: Exercise (Behavioral)
Weight Maintenance
Participants receive Exercise and a Weight Maintenance Diet Interventions
Intervention: Exercise (Behavioral)
Weight Maintenance
Participants receive Exercise and a Weight Maintenance Diet Interventions
Intervention: Weight Maintenance Diet (Behavioral)
Outcomes
Primary Outcomes
Change in Abdominal Fat Mass
Time Frame: Baseline to 1 year
Visceral adipose tissue (cm3) by MRI. Change is calculated as value at baseline minus value at 1 year
Secondary Outcomes
- Cardiometabolic Risk Factors(Baseline to 1 year)
- Weight Change/Maintenance(Baseline to 1 year)
Investigators
Jamy Ard, MD
Associate Professor
University of Alabama at Birmingham