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

Sponsor

National Institute on Aging (NIA) (NIH)

Overall Status

Completed

CT.gov ID

NCT00099151

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Aging Cardiovascular Disease Diabetes Mellitus	Behavioral: Caloric Restriction (CR) Behavioral: Exercise	N/A

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:

Follow a reduced calorie diet
Follow a reduced calorie diet using a liquid diet
Increase physical activity while on a reduced calorie diet
Follow a standard diet.

Three separate five-day inpatient stays are required.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single

Primary Purpose:

Prevention

Official Title:

Metabolic Adaptations to Six Month Caloric Restriction

Study Start Date :

Mar 1, 2002

Actual Primary Completion Date :

May 1, 2006

Actual Study Completion Date :

May 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Pennington Biomedical Research Center, 6400 Perkins Road	Baton Rouge	Louisiana	United States	70808

Sponsors and Collaborators

National Institute on Aging (NIA)

Investigators

Principal Investigator: Eric Ravussin, Ph.D., Pennington Biomedical Research Center
Principal Investigator: Donald Williamson, Ph.D., Pennington Biomedical Research Center