Status:
COMPLETED
Dietary Energy Restriction and Metabolic Aging in Humans
Lead Sponsor:
National Institute on Aging (NIA)
Conditions:
Obesity
Eligibility:
All Genders
20-42 years
Phase:
NA
Brief Summary
The purpose of this study is to develop an effective calorie restricted diet.
Detailed Description
This study is a 3-phase investigation designed to test two caloric restriction (CR) regimens for participant compliance and variability in metabolic and physiologic effects. Initially, and through pha...
Eligibility Criteria
Inclusion
- Healthy men and women (based on standard laboratory tests and a screening examination)
- 20-42 years of age
- BMI in the range 25-29.9 kg/m2
- Proportional representation of minorities in the Greater Boston Area (7 percent Black, 11 percent Hispanic, 82 percent non-Hispanic white)
- Able to accurately complete a food record
- Stage of change \>1 for weight loss and changing dietary intake
- Must have an immediate adult family member who is supportive of weight loss
Exclusion
- Known serious disorders that affect longevity, energy metabolism, body composition and immune responsiveness, including diabetes, cancer, heart disease, cachexia, eating disorders (anorexia and bulimia and any vomiting for means of weight control), depression, alcoholism, inflammatory disorders and AIDS, and individuals taking medicine that is anticipated to influence lifespan or energy metabolism
- Abnormal kidney function as assessed by serum creatinine, BUN and urinalysis, and abnormal liver function as assessed by SGPT, SGOT alkaline phosphatase, and bilirubin, abnormal normal thyroid function as assessed by serum T4 and TSH and fasting serum glucose levels \<125 mg/dl
- Smoking, highly restrained eating, reported endurance training (participation in sports or training \>12 hours per week), alcohol intake of 14 oz. per week or more, major medical and/or psychiatric disorders, plans to have a child within 3 years (1 year for Pilot study), past childbearing (for women) within the last 2 years, or breastfeeding within the past year
- Amputees
- Have required treatment for any psychiatric disorder
- Gained or lost \>15 lb weight within the past year, or taking medications known or suspected to have an important influence on lifespan, energy metabolism, body composition or immune function
- Early death from cardiovascular diseases, cancer, or a diabetes-related illness (before the age of 45 years) in one or both of the parents
- Unable to remain in the program for at least 1 year, or unsuitable for home-based programs (including individuals reporting binge eating disorders or clinical depression, and women intending to become pregnant)
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00183027
Start Date
November 1 2002
End Date
December 1 2004
Last Update
November 9 2006
Active Locations (1)
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1
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, United States, 02111