NCT07628764

Brief Summary

This prospective observational study aims to characterize within-individual variability in resting metabolic rate (RMR) over a 12-week period using high-frequency repeated measurements under standardized conditions. Participants will undergo RMR assessments three times per week using whole-room indirect calorimetry. The study will quantify the magnitude of physiological variability in RMR, distinguish true biological variation from measurement error, and estimate the minimal detectable change required to identify meaningful metabolic adaptations.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
17mo left

Started Jul 2026

Status
not yet 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

First Submitted

Initial submission to the registry

June 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
26 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

1.4 years

First QC Date

June 1, 2026

Last Update Submit

June 1, 2026

Conditions

Keywords

Resting Metabolic RateEnergy ExpenditureMetabolismIndirect CalorimetryVariability

Outcome Measures

Primary Outcomes (1)

  • Within-Individual Variability in Resting Metabolic Rate (RMR)

    Within-individual variability in resting metabolic rate (RMR) assessed using repeated measurements under standardized conditions. Variability will be quantified using mean, standard deviation (SD), and coefficient of variation (CV%) across repeated measurements.

    12 weeks

Secondary Outcomes (3)

  • Minimal Detectable Change (MDC) in RMR

    12 weeks

  • Between-Individual Variability in RMR

    12 weeks

  • Temporal Trends in RMR

    12 weeks

Study Arms (1)

Healthy Adults

Healthy adult participants undergoing repeated measurements of resting metabolic rate (RMR) three times per week over a 12-week period under standardized conditions. No intervention is applied.

Other: Repeated Measurement of Resting Metabolic Rate

Interventions

Repeated assessment of resting metabolic rate under standardized conditions; no intervention is administered.

Healthy Adults

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy adult men and women from the community, aged 18-65 years, who are clinically healthy and able to participate in repeated metabolic measurements under standardized laboratory conditions.

You may qualify if:

  • Adults aged 18-65 years
  • Clinically healthy individuals
  • Stable body weight (±2 kg) over the past 3 months
  • Ability and willingness to attend morning measurements three times per week for 12 weeks
  • Ability to provide informed consent

You may not qualify if:

  • Known uncontrolled endocrine or metabolic disease
  • Use of medications known to significantly affect resting metabolic rate (e.g., systemic corticosteroids, unstable thyroid hormone therapy)
  • Acute illness within 14 days prior to enrollment
  • Pregnancy or lactation
  • Any medical condition that, in the opinion of the investigators, may interfere with safe participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Yftach Prof. Gepner

    Tel Aviv University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yftach Prof. Gepner

CONTACT

Lien Bruck

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator - Professor

Study Record Dates

First Submitted

June 1, 2026

First Posted

June 5, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

June 5, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share