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

This study has been completed.
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00099151
First received: December 8, 2004
Last updated: December 9, 2009
Last verified: December 2004
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Metabolic Adaptations to Six Month Caloric Restriction

Resource links provided by NLM:


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

Estimated Enrollment: 48
Study Start Date: March 2002
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
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
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, see Learn About Clinical Studies.

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

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00099151     History of Changes
Other Study ID Numbers: AG0005, 5U01AG020478-02
Study First Received: December 8, 2004
Last Updated: December 9, 2009
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 24, 2014