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
  Purpose

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 Intervention Phase
Aging
Behavioral: Caloric Restriction (CR)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Dietary Energy Restriction and Metabolic Aging in Humans

Further study details as provided by National Institute on Aging (NIA):

Estimated Enrollment: 44
Study Start Date: March 2002
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   25 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Susan B. Roberts, PhD Jean Mayer USDA HNRCA at Tufts University
  More Information

Additional Information:
No publications provided by National Institute on Aging (NIA)

Additional 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
Study First Received: December 8, 2004
Last Updated: December 9, 2009
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on July 26, 2014