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

This study has been completed.
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00099099
First received: December 8, 2004
Last updated: December 9, 2009
Last verified: February 2006

December 8, 2004
December 9, 2009
March 2002
December 2004   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00099099 on ClinicalTrials.gov Archive Site
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CALERIE (Tufts) - Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Aging
Behavioral: Caloric Restriction (CR)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
December 2004
December 2004   (final data collection date for primary outcome measure)

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
Both
25 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00099099
AG0006, 3U01AG020480
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National Institute on Aging (NIA)
Not Provided
Principal Investigator: Susan B. Roberts, PhD Jean Mayer USDA HNRCA at Tufts University
National Institute on Aging (NIA)
February 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP