Calorie Restriction and Changes in Body Composition, Disease, Function, and Quality of Life in Older Adults
Completed · Phase 3
Conditions studied: Obesity, Diabetes, Hypertension, Hyperlipidemia
In brief
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.
Key facts
- Study ID
- NCT00955903
- Run by
- University of Alabama at Birmingham
- People needed
- 167
- Starts
- 2010-06-01
- Expected to finish
- 2014-08-01
- Last updated by the study team
- 2017-09-05
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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