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

December 9, 2009 updated by: National Institute on Aging (NIA)

Metabolic Adaptations to Six Month Caloric Restriction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Eric Ravussin, Ph.D., Pennington Biomedical Research Center
  • Principal Investigator: Donald Williamson, Ph.D., Pennington Biomedical Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

December 8, 2004

First Submitted That Met QC Criteria

December 8, 2004

First Posted (Estimate)

December 9, 2004

Study Record Updates

Last Update Posted (Estimate)

December 11, 2009

Last Update Submitted That Met QC Criteria

December 9, 2009

Last Verified

December 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AG0005
  • 5U01AG020478-02 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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