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

National Institutes of Health (NIH)

Status

Completed

Conditions

Aging

Diabetes Mellitus

Cardiovascular Disease

Treatments

Behavioral: Caloric Restriction (CR)

Behavioral: Exercise

Study type

Interventional

Funder types

NIH

Identifiers

NCT00099151

AG0005

5U01AG020478-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

25 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.