The CALERIE™ Legacy Study

Tufts University

Status

Enrolling

Conditions

Calorie Restriction

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT05651620

STUDY00002577

1R01AG071717-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

216 estimated patients

Sex

All

Ages

33 to 70 years old

Volunteers

Accepts Healthy Volunteers

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