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

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ClinicalTrials.gov Identifier: NCT00099099
Recruitment Status : Completed
First Posted : December 9, 2004
Last Update Posted : December 11, 2009
Sponsor:
Information provided by:
National Institute on Aging (NIA)

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Aging Behavioral: Caloric Restriction (CR) Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Dietary Energy Restriction and Metabolic Aging in Humans
Study Start Date : March 2002
Actual Primary Completion Date : December 2004
Actual Study Completion Date : December 2004
Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00099099


Locations
United States, Massachusetts
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, United States, 02111-1524
Sponsors and Collaborators
National Institute on Aging (NIA)
Investigators
Principal Investigator: Susan B. Roberts, PhD Jean Mayer USDA HNRCA at Tufts University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
CALERIE Coordinating Center  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00099099     History of Changes
Other Study ID Numbers: AG0006
3U01AG020480 ( U.S. NIH Grant/Contract )
First Posted: December 9, 2004    Key Record Dates
Last Update Posted: December 11, 2009
Last Verified: February 2006

Keywords provided by National Institute on Aging (NIA):
Longevity
Calorie restriction
Physical activity
Weight loss