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

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. Identifier: NCT00099151
Recruitment Status : Completed
First Posted : December 9, 2004
Last Update Posted : December 11, 2009
Information provided by:
National Institute on Aging (NIA)

Brief Summary:
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 or disease Intervention/treatment Phase
Aging Cardiovascular Disease Diabetes Mellitus Behavioral: Caloric Restriction (CR) Behavioral: Exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Metabolic Adaptations to Six Month Caloric Restriction
Study Start Date : March 2002
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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 identifier (NCT number): NCT00099151

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United States, Louisiana
Pennington Biomedical Research Center, 6400 Perkins Road
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
National Institute on Aging (NIA)
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Principal Investigator: Eric Ravussin, Ph.D. Pennington Biomedical Research Center
Principal Investigator: Donald Williamson, Ph.D. Pennington Biomedical Research Center
Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):

Layout table for additonal information Identifier: NCT00099151    
Other Study ID Numbers: AG0005
5U01AG020478-02 ( U.S. NIH Grant/Contract )
First Posted: December 9, 2004    Key Record Dates
Last Update Posted: December 11, 2009
Last Verified: December 2004
Keywords provided by National Institute on Aging (NIA):
Dietary restriction
Physical activity
Weight Loss
Additional relevant MeSH terms:
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Cardiovascular Diseases