- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07628764
Within-Individual Variability of Resting Metabolic Rate Over 12 Weeks
Within-Individual Variability of Resting Metabolic Rate Assessed Repeatedly Over 12 Weeks Using Whole-Room Calorimetry
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Resting metabolic rate (RMR) is a major component of total daily energy expenditure and is widely used in metabolic research. However, most studies rely on single or infrequent measurements, assuming RMR is stable within individuals.
Emerging evidence suggests that RMR exhibits measurable within-individual variability, but the temporal structure and magnitude of this variability remain poorly characterized.
This study will implement a high-frequency repeated-measures design, with RMR measured three times per week over 12 weeks using whole-room indirect calorimetry under standardized conditions. This approach will allow detailed characterization of short-term variability and provide estimates for within-subject variability, measurement error, and minimal detectable change.
The findings will inform interpretation of longitudinal metabolic studies and improve study design in future research.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Yftach Prof. Gepner
- Phone Number: +972 50-682-8501
- Email: gepner@tauex.tau.ac.il
Study Contact Backup
- Name: Lien Bruck
- Phone Number: +972 587487431
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
Repeated assessment of resting metabolic rate under standardized conditions; no intervention is administered.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Within-Individual Variability in Resting Metabolic Rate (RMR)
Time Frame: 12 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Minimal Detectable Change (MDC) in RMR
Time Frame: 12 weeks
|
The minimal detectable change in resting metabolic rate required to distinguish true physiological change from measurement variability.
|
12 weeks
|
|
Between-Individual Variability in RMR
Time Frame: 12 weeks
|
Assessment of variability in resting metabolic rate between participants based on repeated measurements.
|
12 weeks
|
|
Temporal Trends in RMR
Time Frame: 12 weeks
|
Assessment of systematic changes in resting metabolic rate over time using repeated measurements across the study period.
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yftach Prof. Gepner, Tel Aviv University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 0012137-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Resting Metabolic Rate
-
Pennington Biomedical Research CenterWeight Watchers InternationalCompletedResting Metabolic RateUnited States
-
MicrolifeCompletedResting Metabolic RateUnited States
-
Florida State UniversityCompletedHeart Rate Variability | Appetite | Resting Metabolic RateUnited States
-
Karolinska InstitutetThe Swedish Research Council; Swedish Heart Lung FoundationCompleted
-
Tel Aviv UniversityNot yet recruitingResting Metabolic Rate | Metabolism DisordersIsrael
-
University of ThessalyCompletedBody Composition | Physical Fitness | Energy Expenditure | Resting Metabolic RateGreece
-
University of ThessalyCompletedBody Composition | Physical Fitness | Energy Expenditure | Resting Metabolic RateGreece
-
New York University Abu DhabiIQAir AG; LUT UniversityCompletedSleep | Heart Rate | Respiratory Rate | Air Pollution Exposure | SpO2 | HRV | Resting Heart RateUnited Arab Emirates
-
Iberoamerican Institute of Sports Science and Human...CompletedAthletic Injuries | Disability Physical | Resting Metabolic RateMexico
-
AmgenWithdrawnHeart Transplantation, Elevated Resting Heart Rate
Clinical Trials on Repeated Measurement of Resting Metabolic Rate
-
Milton S. Hershey Medical CenterCompletedDietary Habits | Spinal Cord InjuriesUnited States
-
University of Sao Paulo General HospitalCompleted
-
Czech Technical University in PragueRecruiting
-
Gemin XCompletedMyelodysplastic SyndromesCanada, United States
-
Gemin XCompletedHodgkin's LymphomaUnited States
-
Karolinska InstitutetThe Swedish Research Council; Swedish Heart Lung FoundationCompleted
-
University of AberdeenEnrolling by invitationHuntington DiseaseUnited Kingdom
-
Hacettepe UniversityAnkara Bilkent City HospitalRecruitingInflammation | Colorectal Cancer | Diet, Healthy | Diet Habit | Nutrition Aspect of CancerTurkey
-
Pennington Biomedical Research CenterCompleted
-
Rabin Medical CenterBaxter Healthcare CorporationUnknown