CALERIE (Washington University): 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: NCT00099138
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 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 or disease Intervention/treatment Phase
Aging Behavioral: Caloric Restriction (CR) Behavioral: Exercise Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Caloric Restriction and Aging in Humans
Study Start Date : March 2002
Primary Completion Date : February 2006
Study Completion Date : February 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.

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

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): 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

Additional Information:
Publications of Results:
Other Publications:
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 )
First Posted: December 9, 2004    Key Record Dates
Last Update Posted: December 11, 2009
Last Verified: February 2006

Keywords provided by National Institute on Aging (NIA):
Caloric Restriction
Energy Metabolism
Primary Aging
Secondary Aging