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

NCT00099151 | Completed

• 2 other identifiers: AG00055U01AG020478-02
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aging; Cardiovascular Disease; Diabetes Mellitus

Keywords

Longevity; Dietary restriction; Physical activity; Weight Loss; Diabetes

Interventions

Caloric Restriction (CR) BEHAVIORAL

Exercise BEHAVIORAL

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute on Aging (NIA): lead

Study Sites (1)

Pennington Biomedical Research Center, 6400 Perkins Road

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (19)

• 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. doi: 10.1093/ajcn/78.3.361.

  PMID: 12936916 BACKGROUND

• Jenkins RR, Goldfarb A. Introduction: oxidant stress, aging, and exercise. Med Sci Sports Exerc. 1993 Feb;25(2):210-2.

  PMID: 8450723 BACKGROUND

• Sohal RS, Weindruch R. Oxidative stress, caloric restriction, and aging. Science. 1996 Jul 5;273(5271):59-63. doi: 10.1126/science.273.5271.59.

  PMID: 8658196 BACKGROUND

• Ryan AS. Insulin resistance with aging: effects of diet and exercise. Sports Med. 2000 Nov;30(5):327-46. doi: 10.2165/00007256-200030050-00002.

  PMID: 11103847 BACKGROUND

• Masoro EJ. Food restriction in rodents: an evaluation of its role in the study of aging. J Gerontol. 1988 May;43(3):B59-64. doi: 10.1093/geronj/43.3.b59. No abstract available.

  PMID: 3283209 BACKGROUND

• 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. doi: 10.1001/jama.295.13.1539.

  PMID: 16595757 RESULT

• Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.

  PMID: 33512717 DERIVED

• Thomas DM, Martin CK, Redman LM, Heymsfield SB, Lettieri S, Levine JA, Bouchard C, Schoeller DA. Effect of dietary adherence on the body weight plateau: a mathematical model incorporating intermittent compliance with energy intake prescription. Am J Clin Nutr. 2014 Sep;100(3):787-95. doi: 10.3945/ajcn.113.079822. Epub 2014 Jul 30.

  PMID: 25080458 DERIVED

• Lam YY, Redman LM, Smith SR, Bray GA, Greenway FL, Johannsen D, Ravussin E. Determinants of sedentary 24-h energy expenditure: equations for energy prescription and adjustment in a respiratory chamber. Am J Clin Nutr. 2014 Apr;99(4):834-42. doi: 10.3945/ajcn.113.079566. Epub 2014 Feb 5.

  PMID: 24500151 DERIVED

• Tam CS, Frost EA, Xie W, Rood J, Ravussin E, Redman LM; Pennington CALERIE Team. No effect of caloric restriction on salivary cortisol levels in overweight men and women. Metabolism. 2014 Feb;63(2):194-8. doi: 10.1016/j.metabol.2013.10.007. Epub 2013 Oct 24.

  PMID: 24268369 DERIVED

• Huffman KM, Redman LM, Landerman LR, Pieper CF, Stevens RD, Muehlbauer MJ, Wenner BR, Bain JR, Kraus VB, Newgard CB, Ravussin E, Kraus WE. Caloric restriction alters the metabolic response to a mixed-meal: results from a randomized, controlled trial. PLoS One. 2012;7(4):e28190. doi: 10.1371/journal.pone.0028190. Epub 2012 Apr 16.

  PMID: 22523532 DERIVED

• 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.

  PMID: 22127229 DERIVED

• 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. doi: 10.1210/jc.2011-1286. Epub 2011 Jul 21.

  PMID: 21778216 DERIVED

• 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. doi: 10.1038/oby.2009.408. Epub 2009 Nov 12.

  PMID: 19910943 DERIVED

• 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. doi: 10.1111/j.1474-9726.2009.00530.x. Epub 2009 Oct 30.

  PMID: 19878147 DERIVED

• 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. doi: 10.1111/j.1365-277X.2008.00943.x.

  PMID: 19302119 DERIVED

• 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. doi: 10.1371/journal.pone.0004377. Epub 2009 Feb 9.

  PMID: 19198647 DERIVED

• 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. doi: 10.1001/archinte.168.17.1859.

  PMID: 18809812 DERIVED

• 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. doi: 10.1210/jc.2006-2184. Epub 2007 Jan 2.

  PMID: 17200169 DERIVED

Related Links

• CALERIE - PBRC website

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus; Motor Activity; Weight Loss

Interventions

Caloric Restriction; Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Eric Ravussin, Ph.D.

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

• Donald Williamson, Ph.D.

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: December 8, 2004
• First Posted: December 9, 2004
• Study Start: March 1, 2002
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: December 11, 2009

Record last verified: 2004-12

Locations

US (1)