Phase 3
N=164
Calorie Restriction and Changes in Body Composition, Disease, Function, and Quality of Life in Older Adults
Obesity · Diabetes · Hypertension · Hyperlipidemia
Bottom Line
View on ClinicalTrials.gov: NCT00955903 ↗Enrolled (actual)
164
Serious AEs
18.9%
Results posted
Jun 2017
Primary outcome: Primary: Change in Abdominal Fat Mass — -192.6; -21.9; -275 Cubic cm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Exercise (Behavioral); Reduced Calorie Diet (Behavioral); Weight Maintenance Diet (Behavioral)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Abdominal Fat Mass |
-192.6; -21.9; -275 | — |
| SECONDARY Cardiometabolic Risk Factors |
-7.2; 1.2; -1.2 | — |
| SECONDARY Weight Change/Maintenance |
-3.9; -1.3; -0.9 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00955903). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.