Status:
COMPLETED
Calorie Restriction and Changes in Body Composition, Disease, Function, and Quality of Life in Older Adults
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Obesity
Diabetes
Eligibility:
All Genders
65+ years
Phase:
PHASE3
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
167 Patients enrolled
Trial Details
Trial ID
NCT00955903
Start Date
June 1 2010
End Date
August 1 2014
Last Update
September 5 2017
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294