The CALERIE™ Legacy Study

NCT ID: NCT05651620

Last Updated: 2025-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

216 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-06

Study Completion Date

2027-01-31

Brief Summary

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The purpose of the CALERIE Legacy Study is to follow up on the health and wellness of participants from phase 2 of the Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy (CALERIE) trial, which was conducted from 2007 to 2011.

Detailed Description

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The CALERIE Legacy Study is an observational follow-up study of participants from phase 2 the CALERIE trial, the first randomized controlled trial of calorie restriction (CR) in humans without obesity. The overarching goal of the CALERIE Legacy Study is to examine whether two years of CR results in sustained improvements in the biological, phenotypic, and functional hallmarks of human aging 10 to 15 years after the structured intervention. Participants will complete clinical assessments, dietary recalls, and questionnaires, and laboratory evaluations will be performed on blood and urine samples. The study also includes an optional biospecimen banking component.

Conditions

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Calorie Restriction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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Calorie Restriction (CR)

Individuals in the CR group were prescribed a 25% reduction from their baseline energy intake during the two-year CALERIE trial.

No interventions assigned to this group

Ad Libitum (AL)

Individuals in the AL group were asked to continue their usual dietary intake during the two-year CALERIE trial.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Enrolled in the CALERIE trial and started their allocated group (CR intervention or ad libitum control condition)
* Willing and able to attend one of the clinical sites for an in-person visit and provide informed consent

Exclusion Criteria

* Pregnant women
* Women less than 12 months postpartum
* Documented note from the CALERIE trial indicating that the subject should not be contacted or requested not to be contacted for future research
* Diagnosed active cancer or terminal illness
Minimum Eligible Age

33 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pennington Biomedical Research Center

OTHER

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Tufts University

OTHER

Sponsor Role lead

Responsible Party

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Sai Krupa Das

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sai Krupa Das, PhD

Role: PRINCIPAL_INVESTIGATOR

Tufts University

Locations

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Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status

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

Boston, Massachusetts, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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1R01AG071717-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00002577

Identifier Type: -

Identifier Source: org_study_id

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