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CALERIE (PBRC, Baton Rouge) - Comprehensive Assessment of Long-Term Effects of Reducing Intake of Energy

This study has been completed.

Sponsored by: National Institute on Aging (NIA)
Information provided by: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00099151
  Purpose

This study is one of three CALERIE trials that test the hypothesis that a reduced calorie, nutritionally sound diet improves biomarkers of aging and prevents some age-related chronic diseases such as cancer, diabetes, and cardiovascular disease. The three sites that are participating in the CALERIE trial represent a diversity of subject populations and interventional strategies.


Condition Intervention
Aging
Cardiovascular Disease
Diabetes Mellitus
Behavioral: Caloric Restriction (CR)
Behavioral: Exercise

Genetics Home Reference related topics:   Heart Diseases   Vascular Diseases  

MedlinePlus related topics:   Diabetes  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Metabolic Adaptations to Six Month Caloric Restriction

Further study details as provided by National Institute on Aging (NIA):

Estimated Enrollment:   48
Study Start Date:   March 2002
Estimated Study Completion Date:   August 2004

Detailed Description:

This study tests whether chronic caloric restriction improves risk factors of longevity in humans as it is known to do in animals, by measuring a variety of factors dealing with metabolism and oxidative stress, through physical evaluations and laboratory tests.

Participants will receive dietary counseling and free medical evaluations. In addition, each volunteer will be asked to do one of the following:

  1. Follow a reduced calorie diet
  2. Follow a reduced calorie diet using a liquid diet
  3. Increase physical activity while on a reduced calorie diet
  4. Follow a standard diet.

Three separate five-day inpatient stays are required.

  Eligibility
Ages Eligible for Study:   25 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Resident of greater Baton Rouge area for 1 year or longer
  • Men between ages 25-50
  • Women between ages 25-45
  • Body Mass Index (BMI) between 25-30 (never having had BMI greater than 32)
  • Healthy, non-smokers with no history of cardiovascular disease, high blood pressure, diabetes, eating disorder, or major psychiatric disorder

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Personal history of cardiovascular disease or elevated high blood pressure (higher than 160/90 mmHg)
  • Abnormal electrocardiogram (EKG)
  • Personal history of diabetes
  • Personal history of major psychiatric disorders
  • Personal history of eating disorder
  • Smoking
  • Exercising regularly (more than twice a week)
  • Individuals with alcoholism or other substance abuse
  • Post obese (never have had a BMI greater than 32)
  • Regular use of medications, except oral contraceptives
  • Individuals who were ever injured by a metallic foreign body which was not removed
  • Individuals who wear braces on their teeth, have non-removable false teeth, or non-removable bridgework
  • Individuals in occupations requiring full alertness and motor skills (airline pilots, etc.) where even a small chance of postural dizziness would be unacceptable.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00099151

Locations
United States, Louisiana
Pennington Biomedical Research Center, 6400 Perkins Road    
      Baton Rouge, Louisiana, United States, 70808

Sponsors and Collaborators

Investigators
Principal Investigator:     Eric Ravussin, Ph.D.     Pennington Biomedical Research Center    
Principal Investigator:     Donald Williamson, Ph.D.     Pennington Biomedical Research Center    
  More Information

CALERIE - PBRC website  This link exits the ClinicalTrials.gov site
 
CALERIE Coordinating Center  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Other Publications:

Publications indexed to this study:

Study ID Numbers:   AG0005, 5U01AG020478-02
First Received:   December 8, 2004
Last Updated:   May 2, 2006
ClinicalTrials.gov Identifier:   NCT00099151
Health Authority:   United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
Longevity  
Dietary restriction  
Physical activity  
Weight Loss  
Diabetes  

Study placed in the following topic categories:
Body Weight
Weight Loss
Diabetes Mellitus
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 03, 2008




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