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CALERIE (Tufts) - Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy
This study has been completed.
Sponsor:
National Institute on Aging (NIA)
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
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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 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) |
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 (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
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
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
National Institute on Aging (NIA)
Investigators
| Principal Investigator: | Susan B. Roberts, PhD | Jean Mayer USDA HNRCA at Tufts University |
More Information
Additional Information:
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 ( US NIH Grant/Contract Award Number ) |
| Study First Received: | December 8, 2004 |
| Last Updated: | December 9, 2009 |
Keywords provided by National Institute on Aging (NIA):
|
Longevity Calorie restriction Physical activity Weight loss |
ClinicalTrials.gov processed this record on June 26, 2017