CALERIE (Tufts) - Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy

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.

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Key information

Conditions

Aging Behavior Body Weight Body Weight Changes Motor Activity Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, 02111-1524, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caloric Restriction (CR)

Behavioral

Sponsors and collaborators

Lead sponsor

National Institute on Aging (NIA)

Nih

Registry information

Official study title

Dietary Energy Restriction and Metabolic Aging in Humans

Important dates

Study start: 2002
Primary completion: 2004
Study completion: 2004
First posted: Dec 9, 2004
Registry last updated: Dec 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed