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

Phase 3

Completed

• Conditions: Obesity; Hyperlipidemia; Diabetes; Hypertension

• 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

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