NCT05651620

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
216

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Apr 2023

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
active not recruiting

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 Progress81%
Apr 2023Jan 2027

First Submitted

Initial submission to the registry

September 1, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 15, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

April 6, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Expected
Last Updated

October 30, 2025

Status Verified

October 1, 2025

Enrollment Period

3 years

First QC Date

September 1, 2022

Last Update Submit

October 28, 2025

Conditions

Calorie Restriction

Keywords

calorie restrictiondietary interventionbiological agingbehavioral data

Outcome Measures

Primary Outcomes (2)

  • Biological age - Klemera-Doubal Method

    Biological age will be quantified by the Klemera-Doubal Method (KDM), an algorithm-based measure. Biological age is expressed in years.

    10-15 years post CALERIE trial

  • Healthspan

    Healthspan will be assessed by sex-specific metabolic syndrome score (MSS). MSS was developed using mean blood pressure (MBP; = \[2 × diastolic blood pressure + systolic blood pressure\]/3), high density lipoprotein cholesterol (HDL), triglycerides (TG), waist circumference (WC), and fasting blood glucose (FBG): Women: MSS = \[45-HDL\]/SDHDLW+ \[TG-150\]/SDTG + \[WC-88\]/SDWCW + \[FBG-100\]/SDFBG + \[mean BP-100\]/SDMBP Men: MSS = \[40-HDL\]/SDHDLW+ \[TG-150\]/SDTG + \[WC-102\]/SDWCW + \[FBG-100\]/SDFBG + \[mean BP-100\]/SDMBP This score does not have a unit.

    10-15 years post CALERIE trial

Secondary Outcomes (105)

  • Height

    10-15 years post CALERIE trial

  • Weight

    10-15 years post CALERIE trial

  • Waist circumference

    10-15 years post CALERIE trial

  • Hip circumference

    10-15 years post CALERIE trial

  • Body mass index (BMI)

    10-15 years post CALERIE trial

  • +100 more secondary outcomes

Study Arms (2)

Calorie Restriction (CR)

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

Ad Libitum (AL)

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

Eligibility Criteria

Age33 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All CALERIE participants, except those who are deceased, are known not to qualify, or did not start their allocated group (CR intervention or ad libitum control) (n = 4), have been identified as potential subjects (n = 216) in the CALERIE Legacy Study. The demographic profile of this study is expected to be similar to that of the CALERIE trial, which was 70.4% female. Healthy individuals without obesity of either sex and all race and ethnic groups were eligible to participate in the CALERIE trial. However, due to safety concerns, pregnant women were excluded, and to avoid confounding from peri- and post-menopausal status, the upper age limit for women was 47 years. Upon enrollment, CALERIE participants were 21-50y, 77.3% White, 12% Black, and 10.7% other; ethnicity was 97% non-Hispanic.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

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

Boston, Massachusetts, 02111, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110-1010, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood (whole blood, plasma, serum, buffy coat, red blood cells) and urine

Study Officials

  • Sai Krupa Das, PhD

    Tufts University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 1, 2022

First Posted

December 15, 2022

Study Start

April 6, 2023

Primary Completion

March 31, 2026

Study Completion (Estimated)

January 31, 2027

Last Updated

October 30, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

Per the NIH Data Public Access Policy, after study closure, the data coordinating center at Duke University will lock the electronic database and clean and deidentify the data prior to public posting. Biospecimens collected for banking will be deidentified and transferred to the NIA AgingResearchBiobank, which utilizes a state-of-the-art inventory system for the storage and distribution of study samples for future scientific research. The study protocol and informed consent form will be made available as well.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Data will be posted for open access use at the time of publication of the primary manuscript. Biospecimens will be stored at the NIA Biobank and will be available upon study completion and until all samples are depleted or deemed not viable.
Access Criteria
Permission to use data will not be restricted. However, interested investigators must register with the applicable website to access data, which will be made available via download. Data collected in this study will be appropriate for regression adapted to longitudinal data and multivariate-multivariable analysis or goodness-of-fit chi-square, non-parametric measures of association. Investigators interested in accessing biospecimens will need to apply for access by submitting a request via the NIA AgingResearchBiobank website (https://agingresearchbiobank.nia.nih.gov/how-to-make-a-request/). To submit this request, a designated member of the investigative team will be required to register as a user on the AgingResearchBiobank website. Any investigator can submit a request for access to the biospecimens for future research but must be approved by the AgingResearchBiobank to gain access. Biospecimens will be provided as samples that will be shipped to approved investigators.

Locations

US(3)