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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00955903
Recruitment Status : Completed
First Posted : August 10, 2009
Results First Posted : June 28, 2017
Last Update Posted : September 5, 2017
Sponsor:
Information provided by (Responsible Party):
Jamy Ard, MD, University of Alabama at Birmingham

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity Diabetes Hypertension Hyperlipidemia Behavioral: Exercise Behavioral: Reduced Calorie Diet Behavioral: Weight Maintenance Diet Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 167 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Calorie Restriction and Changes in Body Composition, Disease, Function, and Quality of Life in Older Adults
Study Start Date : June 2010
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arms and Interventions
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Arm Intervention/treatment
Experimental: Weight Loss
Participants receive Exercise and Reduced Calorie Diet Interventions
 Behavioral: Exercise
Participants will participate in supervised exercise sessions

Behavioral: Reduced Calorie Diet
Participants will follow a reduced calorie diet
Active Comparator: Control
Participants receive Exercise Intervention
 Behavioral: Exercise
Participants will participate in supervised exercise sessions
Active Comparator: Weight Maintenance
Participants receive Exercise and a Weight Maintenance Diet Interventions
 Behavioral: Exercise
Participants will participate in supervised exercise sessions

Behavioral: Weight Maintenance Diet
Participants will follow a weight maintenance diet


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00955903


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Jamy D Ard, MD University of Alabama at Birmingham
Principal Investigator: Julie Locher, PhD University of Alabama at Birmingham
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jamy Ard, MD, Associate Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00955903    
Other Study ID Numbers: F090430012
First Posted: August 10, 2009    Key Record Dates
Results First Posted: June 28, 2017
Last Update Posted: September 5, 2017
Last Verified: August 2017
Keywords provided by Jamy Ard, MD, University of Alabama at Birmingham:
glucose
insulin
lipids
C-reactive protein
adiponectin
 leptin
TNF alpha
IL-6
Quality of Life
functional status
Additional relevant MeSH terms:
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Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases