NCT00099138

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2002

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2004

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

December 11, 2009

Status Verified

February 1, 2006

Enrollment Period

3.9 years

First QC Date

December 8, 2004

Last Update Submit

December 9, 2009

Conditions

Aging

Keywords

DietCaloric RestrictionExerciseEnergy MetabolismPrimary AgingSecondary Aging

Interventions

Caloric Restriction (CR)BEHAVIORAL
ExerciseBEHAVIORAL

Eligibility Criteria

Age50 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 50 to 60
  • Women must be post-menopausal
  • Normal weight to moderately overweight, (Body Mass Index \[BMI\] between 23 - 30)
  • In good health, free of major chronic diseases or conditions
  • Well motivated
  • Reliable

You may not qualify if:

  • Major chronic disease or condition that would interfere with exercise or caloric restriction (such as diabetes, coronary artery disease, significant obstructive airway disease, stroke, resting blood pressure over 170 mmHg systolic and/or 100 mmHg diastolic, history or evidence of malignancy, orthopedic or musculoskeletal problems)
  • Hormone replacement therapy (DHEA, estrogen, thyroid, testosterone)
  • Regular exercise twice or more per week
  • Smoking
  • Alcoholism
  • Frequent travel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University in St. Louis, School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (4)

  • Racette SB, Weiss EP, Obert KA, Kohrt WM, Holloszy JO. Modest lifestyle intervention and glucose tolerance in obese African Americans. Obes Res. 2001 Jun;9(6):348-55. doi: 10.1038/oby.2001.45.

    PMID: 11399781BACKGROUND

  • Fontana L, Meyer TE, Klein S, Holloszy JO. Long-term calorie restriction is highly effective in reducing the risk for atherosclerosis in humans. Proc Natl Acad Sci U S A. 2004 Apr 27;101(17):6659-63. doi: 10.1073/pnas.0308291101. Epub 2004 Apr 19.

    PMID: 15096581RESULT

  • 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: 22127229DERIVED

  • Villareal DT, Fontana L, Weiss EP, Racette SB, Steger-May K, Schechtman KB, Klein S, Holloszy JO. Bone mineral density response to caloric restriction-induced weight loss or exercise-induced weight loss: a randomized controlled trial. Arch Intern Med. 2006 Dec 11-25;166(22):2502-10. doi: 10.1001/archinte.166.22.2502.

    PMID: 17159017DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Caloric RestrictionExercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsEnergy IntakeDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • John O. Holloszy, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
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

February 1, 2006

Study Completion

February 1, 2006

Last Updated

December 11, 2009

Record last verified: 2006-02

Locations

US(1)