CALERIE (Tufts) - Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy
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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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Prevention |
| Official Title: | Dietary Energy Restriction and Metabolic Aging in Humans |
| 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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00099099
| United States, Massachusetts | |
| Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University | |
| Boston, Massachusetts, United States, 02111-1524 | |
| 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 February 25, 2015