NCT00099099

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
44

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2002

Typical duration 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

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
7 days 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
Last Updated

December 11, 2009

Status Verified

February 1, 2006

Enrollment Period

2.8 years

First QC Date

December 8, 2004

Last Update Submit

December 9, 2009

Conditions

Keywords

LongevityCalorie restrictionPhysical activityWeight loss

Interventions

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, 02111-1524, United States

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Motor ActivityWeight Loss

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

BehaviorBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsEnergy IntakeDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Susan B. Roberts, PhD

    Jean Mayer USDA HNRCA at Tufts University

    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

December 1, 2004

Study Completion

December 1, 2004

Last Updated

December 11, 2009

Record last verified: 2006-02

Locations