CALERIE (Tufts) - 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 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.

Detailed Description
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Researchers at the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University are enrolling overweight men and women aged 20-42 in a 1-year study to develop an effective calorie restricted regimen that minimizes hunger and prevents weight regain. The study also examines the effects of weight loss on body composition, metabolism and aging. Two different diets containing usual foods and a healthy balance of nutrients will be tested at 2 levels of caloric restriction, 10% and 30% (in other words, 90% or 70% of what one would normally eat). Weight loss is expected for most volunteers participating in this study, but cannot be guaranteed.

Official Title
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Dietary Energy Restriction and Metabolic Aging in Humans

Conditions
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Aging

Intervention / Treatment
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* Behavioral: Caloric Restriction (CR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Healthy men and women Body mass index (BMI) = 25-30 Slightly overweight, < 275 lbs Women 25-45, pre-menopause Men 25-50 Not traveling often or planning to move Exclusions: Cardiovascular disease or blood pressure greater than 160/90 Diabetes Major psychiatric disorders Eating disorders Post obese; previous BMI > 32 Weight change of more than ten pounds in the past 90 days Over 275 pounds Smoking Regular exercise, more than twice per week Current prescription drug use, except oral contraceptives Alcoholism or substance abuse Pregnant or lactating (breast feeding), planning to become pregnant, or not regularly using contraception Abnormal electrocardiogram (EKG) Local resident for less than one year Occupations requiring full alertness and motor skills, with no allowance for a chance of postural dizziness (airline pilots, etc.) Injuries by any metallic object that is still present in the body Braces, non-removable dentures, or non-removable bridgework

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|

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, Calorie restriction, Physical activity, Weight loss