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

Aging Clinical Trial

Official title:

Caloric Restriction and Aging in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00099138
• Other study ID #: AG0012
• Secondary ID: 3U01AG020487
• Status: Completed
• Phase: Phase 1
• First received: December 8, 2004
• Last updated: December 9, 2009
• Start date: March 2002
• Est. completion date: February 2006

Study information

• Verified date: February 2006
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aging

Intervention

Behavioral:
• Caloric Restriction (CR)

• Exercise

Locations

Country	Name	City	State
United States	Washington University in St. Louis, School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Fontana L, Meyer TE, Klein S, Holloszy JO. Long-term calorie restriction is highly effective in reducing the risk for atherosclerosis in humans. Proc Natl Acad Sci U S A. 2004 Apr 27;101(17):6659-63. Epub 2004 Apr 19. — View Citation

Racette SB, Weiss EP, Obert KA, Kohrt WM, Holloszy JO. Modest lifestyle intervention and glucose tolerance in obese African Americans. Obes Res. 2001 Jun;9(6):348-55. — View Citation

External Links

•   CALERIE website