CALERIE (PBRC, Baton Rouge) - Comprehensive Assessment of Long-Term Effects of Reducing Intake of Energy - Full Text View

Sponsor:	National Institute on Aging (NIA)
Information provided by:	National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:	NCT00099151

Purpose

This study is one of three CALERIE trials that test the hypothesis that a reduced calorie, nutritionally sound diet improves biomarkers of aging 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
Aging Cardiovascular Disease Diabetes Mellitus	Behavioral: Caloric Restriction (CR) Behavioral: Exercise

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Prevention
Official Title:	Metabolic Adaptations to Six Month Caloric Restriction

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

U.S. FDA Resources

Further study details as provided by National Institute on Aging (NIA):

Estimated Enrollment:	48
Study Start Date:	March 2002
Study Completion Date:	May 2006
Primary Completion Date:	May 2006 (Final data collection date for primary outcome measure)

Detailed Description:

This study tests whether chronic caloric restriction improves risk factors of longevity in humans as it is known to do in animals, by measuring a variety of factors dealing with metabolism and oxidative stress, through physical evaluations and laboratory tests.

Participants will receive dietary counseling and free medical evaluations. In addition, each volunteer will be asked to do one of the following:

Follow a reduced calorie diet
Follow a reduced calorie diet using a liquid diet
Increase physical activity while on a reduced calorie diet
Follow a standard diet.

Three separate five-day inpatient stays are required.

Eligibility

Ages Eligible for Study:	25 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Resident of greater Baton Rouge area for 1 year or longer
Men between ages 25-50
Women between ages 25-45
Body Mass Index (BMI) between 25-30 (never having had BMI greater than 32)
Healthy, non-smokers with no history of cardiovascular disease, high blood pressure, diabetes, eating disorder, or major psychiatric disorder

Exclusion Criteria:

Pregnant or breastfeeding
Personal history of cardiovascular disease or elevated high blood pressure (higher than 160/90 mmHg)
Abnormal electrocardiogram (EKG)
Personal history of diabetes
Personal history of major psychiatric disorders
Personal history of eating disorder
Smoking
Exercising regularly (more than twice a week)
Individuals with alcoholism or other substance abuse
Post obese (never have had a BMI greater than 32)
Regular use of medications, except oral contraceptives
Individuals who were ever injured by a metallic foreign body which was not removed
Individuals who wear braces on their teeth, have non-removable false teeth, or non-removable bridgework
Individuals in occupations requiring full alertness and motor skills (airline pilots, etc.) where even a small chance of postural dizziness would be unacceptable.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00099151

Locations

United States, Louisiana
Pennington Biomedical Research Center, 6400 Perkins Road
Baton Rouge, Louisiana, United States, 70808

Sponsors and Collaborators

National Institute on Aging (NIA)

Investigators

Principal Investigator:	Eric Ravussin, Ph.D.	Pennington Biomedical Research Center
Principal Investigator:	Donald Williamson, Ph.D.	Pennington Biomedical Research Center

More Information

Additional Information:

CALERIE - PBRC website This link exits the ClinicalTrials.gov site

CALERIE Coordinating Center This link exits the ClinicalTrials.gov site

Publications:

Heilbronn LK, de Jonge L, Frisard MI, DeLany JP, Larson-Meyer DE, Rood J, Nguyen T, Martin CK, Volaufova J, Most MM, Greenway FL, Smith SR, Deutsch WA, Williamson DA, Ravussin E; Pennington CALERIE Team. Effect of 6-month calorie restriction on biomarkers of longevity, metabolic adaptation, and oxidative stress in overweight individuals: a randomized controlled trial. JAMA. 2006 Apr 5;295(13):1539-48.

Heilbronn LK, Ravussin E. Calorie restriction and aging: review of the literature and implications for studies in humans. Am J Clin Nutr. 2003 Sep;78(3):361-9. Review.

Jenkins RR, Goldfarb A. Introduction: oxidant stress, aging, and exercise. Med Sci Sports Exerc. 1993 Feb;25(2):210-2. Review. Erratum in: Med Sci Sports Exerc 1993 May;25(5):653.

Sohal RS, Weindruch R. Oxidative stress, caloric restriction, and aging. Science. 1996 Jul 5;273(5271):59-63. Review.

Ryan AS. Insulin resistance with aging: effects of diet and exercise. Sports Med. 2000 Nov;30(5):327-46. Review.

Masoro EJ. Food restriction in rodents: an evaluation of its role in the study of aging. J Gerontol. 1988 May;43(3):B59-64. Review. No abstract available.

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

Lecoultre V, Ravussin E, Redman LM. The fall in leptin concentration is a major determinant of the metabolic adaptation induced by caloric restriction independently of the changes in leptin circadian rhythms. J Clin Endocrinol Metab. 2011 Sep;96(9):E1512-6. Epub 2011 Jul 21.

de Jonge L, Moreira EA, Martin CK, Ravussin E; Pennington CALERIE Team. Impact of 6-month caloric restriction on autonomic nervous system activity in healthy, overweight, individuals. Obesity (Silver Spring). 2010 Feb;18(2):414-6. Epub 2009 Nov 12.

Redman LM, Veldhuis JD, Rood J, Smith SR, Williamson D, Ravussin E; Pennington CALERIE Team. The effect of caloric restriction interventions on growth hormone secretion in nonobese men and women. Aging Cell. 2010 Feb;9(1):32-9. Epub 2009 Oct 30.

Anton SD, Han H, York E, Martin CK, Ravussin E, Williamson DA. Effect of calorie restriction on subjective ratings of appetite. J Hum Nutr Diet. 2009 Apr;22(2):141-7.

Redman LM, Heilbronn LK, Martin CK, de Jonge L, Williamson DA, Delany JP, Ravussin E; Pennington CALERIE Team. Metabolic and behavioral compensations in response to caloric restriction: implications for the maintenance of weight loss. PLoS ONE. 2009;4(2):e4377. Epub 2009 Feb 9.

Redman LM, Rood J, Anton SD, Champagne C, Smith SR, Ravussin E; Pennington Comprehensive Assessment of Long-Term Effects of Reducing Intake of Energy (CALERIE) Research Team. Calorie restriction and bone health in young, overweight individuals. Arch Intern Med. 2008 Sep 22;168(17):1859-66.

Redman LM, Heilbronn LK, Martin CK, Alfonso A, Smith SR, Ravussin E; Pennington CALERIE Team. Effect of calorie restriction with or without exercise on body composition and fat distribution. J Clin Endocrinol Metab. 2007 Mar;92(3):865-72. Epub 2007 Jan 2.

ClinicalTrials.gov Identifier:	NCT00099151 History of Changes
Other Study ID Numbers:	AG0005, 5U01AG020478-02
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
Dietary restriction
Physical activity
Weight Loss
Diabetes

Additional relevant MeSH terms:

Cardiovascular Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on February 09, 2012