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

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 (Adult)
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

National Institute on Aging (NIA)

Investigators


Principal Investigator:	Susan B. Roberts, PhD	Jean Mayer USDA HNRCA at Tufts University

More Information

Additional Information:

CALERIE Coordinating Center This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Karl JP, Cheatham RA, Das SK, Hyatt RR, Gilhooly CH, Pittas AG, Lieberman HR, Lerner D, Roberts SB, Saltzman E. Effect of glycemic load on eating behavior self-efficacy during weight loss. Appetite. 2014 Sep;80:204-11. doi: 10.1016/j.appet.2014.05.017. Epub 2014 May 21.

Racette SB, Das SK, Bhapkar M, Hadley EC, Roberts SB, Ravussin E, Pieper C, DeLany JP, Kraus WE, Rochon J, Redman LM; CALERIE Study Group. Approaches for quantifying energy intake and %calorie restriction during calorie restriction interventions in humans: the multicenter CALERIE study. Am J Physiol Endocrinol Metab. 2012 Feb 15;302(4):E441-8. doi: 10.1152/ajpendo.00290.2011. Epub 2011 Nov 29.


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 September 28, 2016