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

December 9, 2009 updated by: National Institute on Aging (NIA)

Dietary Energy Restriction and Metabolic Aging in Humans

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment

44

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111-1524
        • Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Susan B. Roberts, PhD, Jean Mayer USDA HNRCA at Tufts University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Primary Completion (ACTUAL)

December 1, 2004

Study Completion (ACTUAL)

December 1, 2004

Study Registration Dates

First Submitted

December 8, 2004

First Submitted That Met QC Criteria

December 8, 2004

First Posted (ESTIMATE)

December 9, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

December 11, 2009

Last Update Submitted That Met QC Criteria

December 9, 2009

Last Verified

February 1, 2006

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AG0006
  • 3U01AG020480 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aging

Clinical Trials on Caloric Restriction (CR)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe