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

Diabetes Mellitus Clinical Trial

Official title:

Metabolic Adaptations to Six Month Caloric Restriction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00099151
• Other study ID #: AG0005
• Secondary ID: 5U01AG020478-02
• Status: Completed
• Phase: N/A
• First received: December 8, 2004
• Last updated: December 9, 2009
• Start date: March 2002
• Est. completion date: May 2006

Study information

• Verified date: December 2004
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 50 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Aging
• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes Mellitus

Intervention

Behavioral:
• Caloric Restriction (CR)

• Exercise

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center, 6400 Perkins Road	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (6)

Heilbronn LK, de Jonge L, Frisard MI, DeLany JP, Larson-Meyer DE, Rood J, Nguyen T, Martin CK, Volaufova J, Most MM, Greenway FL, Smith SR, Deutsch WA, Williamson DA, Ravussin E; Pennington CALERIE Team. Effect of 6-month calorie restriction on biomarkers — View Citation

Heilbronn LK, Ravussin E. Calorie restriction and aging: review of the literature and implications for studies in humans. Am J Clin Nutr. 2003 Sep;78(3):361-9. Review. — View Citation

Jenkins RR, Goldfarb A. Introduction: oxidant stress, aging, and exercise. Med Sci Sports Exerc. 1993 Feb;25(2):210-2. Review. Erratum in: Med Sci Sports Exerc 1993 May;25(5):653. — View Citation

Masoro EJ. Food restriction in rodents: an evaluation of its role in the study of aging. J Gerontol. 1988 May;43(3):B59-64. Review. — View Citation

Ryan AS. Insulin resistance with aging: effects of diet and exercise. Sports Med. 2000 Nov;30(5):327-46. Review. — View Citation

Sohal RS, Weindruch R. Oxidative stress, caloric restriction, and aging. Science. 1996 Jul 5;273(5271):59-63. Review. — View Citation

External Links

•   CALERIE - PBRC website
•   CALERIE Coordinating Center