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

Aging Clinical Trial

Official title:

Dietary Energy Restriction and Metabolic Aging in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00099099
• Other study ID #: AG0006
• Secondary ID: 3U01AG020480
• Status: Completed
• Phase: Phase 1
• First received: December 8, 2004
• Last updated: December 9, 2009
• Start date: March 2002
• Est. completion date: December 2004

Study information

• Verified date: February 2006
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aging

Intervention

Behavioral:
• Caloric Restriction (CR)

Locations

Country	Name	City	State
United States	Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

External Links

•   CALERIE Coordinating Center