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OpenTrials
Completed

NCT Number: NCT00955903

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

Participants will participate in supervised exercise sessions

Reduced Calorie Diet

Behavioral

Participants will follow a reduced calorie diet

Weight Maintenance Diet

Behavioral

Participants will follow a weight maintenance diet

Primary outcomes

  1. Change in Abdominal Fat Mass

    Time frame: Baseline to 1 year

    Visceral adipose tissue (cm3) by MRI. Change is calculated as value at baseline minus value at 1 year

Secondary outcomes

  1. Cardiometabolic Risk Factors

    Time frame: Baseline to 1 year

    We are reporting change in blood glucose. Change is calculated as value at baseline minus value at 1 year

  2. Weight Change/Maintenance

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Acronym: CROSSROADS

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Aug 10, 2009
Registry last updated
Sep 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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