Calorie Restriction and Changes in Body Composition, Disease, Function, and Quality of Life in Older Adults

University of Alabama at Birmingham1 site in 1 country167 target enrollmentJune 2010

ConditionsObesity Diabetes Hypertension Hyperlipidemia

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Obesity
Sponsor: University of Alabama at Birmingham
Enrollment: 167
Locations: 1
Primary Endpoint: Change in Abdominal Fat Mass
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

June 2010

End Date

August 2014

Last Updated

8 years ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Investigators

Sponsor

University of Alabama at Birmingham

Responsible Party

Principal Investigator

Jamy Ard, MD

Associate Professor

University of Alabama at Birmingham

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