NCT07305753

Brief Summary

The aim of this study is to develop a dataset with reference body composition measurements using criterion methods. This dataset will be used to develop new protocols to study patients with cancer. Obtaining measurements of sodium bromide (NaBr), deuterium dilution (D2O), and D3-Creatine in a stratified sample of adults will determine the accuracy (and precision) of the available devices for ECW, TBW, and skeletal muscle mass measurements.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
1mo left

Started Oct 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Oct 2025May 2026

Study Start

First participant enrolled

October 15, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 26, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Expected
Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

December 12, 2025

Last Update Submit

December 12, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Skeletal Muscle Mass

    Muscle mass

    Single time point

Study Arms (1)

Cross-sectional group

20 young (20-40yo) and 20 older (70+) adults

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The participants will be community dwelling, have a self-reported ability to walk one-quarter of a mile and climb 10 steps without difficulty, self-reported ability to perform activities of daily living (ADLs) without difficulty, and no life-threatening conditions or diseases that would alter their body composition from what is typical for their age, sex, and BMI. Overall, participants must be ambulatory, able to withstand lying flat on the DXA table for up to 10 minutes, stand without aid for 2 minutes, weigh less than 440 lbs and be in generally good health.

You may qualify if:

  • Being either male or female
  • Being an adult \>20 - \<40 or \>70 years of age.
  • Having a body weight of less than 440 pounds
  • Being willing to comply with the study procedures
  • Not having a chronic illness (e.g., diabetes, cancer, etc.)
  • Must be willing to have biospecimens and imaging stored for research use

You may not qualify if:

  • Being pregnant, attempting to become pregnant, or breastfeeding
  • Having medical implants such as a pacemaker or metal joint replacements
  • Having had a mastectomy, breast reduction, or breast implants
  • Having hair that cannot fit in a swim cap
  • Having a body weight greater than 440 pounds
  • Taking medications that alter the body's fluid compartments (ex: diuretics)
  • Not willing to have biospecimens and imaging stored for future research use.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

RECRUITING

Central Study Contacts

Steven B Heymsfield, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Boyd Professor

Study Record Dates

First Submitted

December 12, 2025

First Posted

December 26, 2025

Study Start

October 15, 2025

Primary Completion

April 15, 2026

Study Completion (Estimated)

May 30, 2026

Last Updated

December 26, 2025

Record last verified: 2025-12

Locations