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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Metabolic Adaptations to Six Month Caloric Restriction

Conditions
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Aging, Cardiovascular Disease, Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Caloric Restriction (CR)
* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Caloric Restriction (CR)|nan|
|Behavioral: Exercise|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Longevity, Dietary restriction, Physical activity, Weight Loss, Diabetes