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

Obesity Clinical Trial

— CROSSROADS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00955903
• Other study ID #: F090430012
• Status: Completed
• Phase: Phase 3
• First received: August 6, 2009
• Last updated: December 11, 2014
• Start date: June 2010
• Est. completion date: August 2014

Study information

• Verified date: November 2013
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes
• Hyperlipidemia
• Hyperlipidemias
• Hypertension
• Obesity

Intervention

Behavioral:
• Exercise Only
Participants will participate in supervised exercise sessions
• Reduced Calorie Diet
Participants will follow a reduced calorie diet
• Weight Maintenance Diet
Participants will follow a weight maintenance diet

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in abdominal fat mass		1 year	No
Secondary	cardiometabolic risk factors		1 year	No
Secondary	weight change/maintenance		1 year	No