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

Phase 3

Completed

• Conditions: Obesity; Hyperlipidemia; Diabetes; Hypertension
• Interventions: Behavioral: Exercise; Behavioral: Weight Maintenance Diet; Behavioral: Reduced Calorie Diet

• Registration Number: NCT00955903
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-06
• Study First Submitted QC: 2009-08-07
• Study First Posted: 2009-08-10
• Study Start: 2010-06
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Results First Submitted: 2017-04-17
• Results First Submitted QC: 2017-04-17
• Results First Posted: 2017-06-28
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-01
• Last Update Posted: 2017-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Weight Maintenance	Weight Maintenance Diet	Participants receive Exercise and a Weight Maintenance Diet Interventions
Weight Loss	Reduced Calorie Diet	Participants receive Exercise and Reduced Calorie Diet Interventions
Control	Exercise	Participants receive Exercise Intervention
Weight Loss	Exercise	Participants receive Exercise and Reduced Calorie Diet Interventions
Weight Maintenance	Exercise	Participants receive Exercise and a Weight Maintenance Diet Interventions

Primary Outcome Measures

Name	Time	Method
Change in Abdominal Fat Mass	Baseline to 1 year	Visceral adipose tissue (cm3) by MRI. Change is calculated as value at baseline minus value at 1 year

Secondary Outcome Measures

Name	Time	Method
Cardiometabolic Risk Factors	Baseline to 1 year	We are reporting change in blood glucose. Change is calculated as value at baseline minus value at 1 year
Weight Change/Maintenance	Baseline to 1 year	The change in body weight at follow up of 1 year. Change is calculated as value at baseline minus value at 1 year

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States