CALERIE (Tufts) - Comprehensive Assessment of Long-term E... | NCT00099099

Studies
CALERIE (Tufts) - Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy

NCT00099099

Sponsor

National Institute on Aging (NIA)

Status

Completed

Last Update Posted

Dec 11, 2009Estimated

Enrollment

Phase

Phase 1

Conditions

Aging

Interventions

Caloric Restriction (CR)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
3U01AG020480	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Feb 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2002

Primary Completion Date

Dec 2004Actual

Completion Date

Dec 2004Actual

First Submitted Date

Dec 8, 2004

First Submission Date that Met QC Criteria

Dec 8, 2004

First Posted Date

Dec 9, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 9, 2009

Last Update Posted Date

Dec 11, 2009Estimated

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Caloric Restriction (CR)	Behavioral

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Susan B. Roberts, PhD	Jean Mayer USDA HNRCA at Tufts University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University		Boston	Massachusetts	02111-1524	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24859114	Derived	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.
22127229	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.

ID	Term
D009043	Motor Activity
D015431	Weight Loss

ID	Term
D001519	Behavior
D001836	Body Weight Changes
D001835	Body Weight
D012816	Signs and Symptoms

ID	Term
D004035	Diet Therapy
D044623	Nutrition Therapy
D013812	Therapeutics
D002149	Energy Intake