This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

CALERIE (Washington University): Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy

This study has been completed.
Information provided by:
National Institute on Aging (NIA) Identifier:
First received: December 8, 2004
Last updated: December 9, 2009
Last verified: February 2006
This study is one of three CALERIE trials that test the hypothesis that a reduced calorie, nutritionally sound diet increases the length of life 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 Phase
Aging Behavioral: Caloric Restriction (CR) Behavioral: Exercise Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Caloric Restriction and Aging in Humans

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

Estimated Enrollment: 48
Study Start Date: March 2002
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Detailed Description:

Animal studies suggest that caloric restriction (CR), or consuming fewer calories, increases life span, and also protects against some aging-related disease processes such as artherosclerosis and type II diabetes. However, it appears that simply burning more calories through physical activity does not increase life span by itself. It is not known how CR affects humans, but based on this evidence it appears that the reduced total intake and metabolism of food is the main factor, rather than increased exercise alone.

To test this, volunteers will be placed on a program of either 20% caloric restriction or 20% increase of energy expenditure by exercise, or in a control group to be instructed in healthy living. All will be evaluated on a number of potential markers of aging, on body composition, and on risk factors for artherosclerosis and diabetes.

Participation in the study will last for 12 months. The Diet group will receive individual instruction from a registered dietician. The Exercise group will be given an individualized exercise program created by a personal trainer. The Healthy Lifestyle group will be given information on how to make healthier choices; both diet and activity will be discussed. All participants will be measured every two weeks, and will keep daily food and activity logs. All will be seen by a physician and will have lab tests done before beginning the study, at 1 month, and then 3 month intervals.


Ages Eligible for Study:   50 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age 50 to 60
  • Women must be post-menopausal
  • Normal weight to moderately overweight, (Body Mass Index [BMI] between 23 - 30)
  • In good health, free of major chronic diseases or conditions
  • Well motivated
  • Reliable

Exclusion Criteria:

  • Major chronic disease or condition that would interfere with exercise or caloric restriction (such as diabetes, coronary artery disease, significant obstructive airway disease, stroke, resting blood pressure over 170 mmHg systolic and/or 100 mmHg diastolic, history or evidence of malignancy, orthopedic or musculoskeletal problems)
  • Hormone replacement therapy (DHEA, estrogen, thyroid, testosterone)
  • Regular exercise twice or more per week
  • Smoking
  • Alcoholism
  • Frequent travel
  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 identifier: NCT00099138

United States, Missouri
Washington University in St. Louis, School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
National Institute on Aging (NIA)
Principal Investigator: John O. Holloszy, MD Washington University School of Medicine
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00099138     History of Changes
Other Study ID Numbers: AG0012
3U01AG020487 ( U.S. NIH Grant/Contract )
Study First Received: December 8, 2004
Last Updated: December 9, 2009

Keywords provided by National Institute on Aging (NIA):
Caloric Restriction
Energy Metabolism
Primary Aging
Secondary Aging processed this record on August 18, 2017