- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Yftach Prof. Gepner
- Telefonnummer: +972 50-682-8501
- E-mail: gepner@tauex.tau.ac.il
Undersøgelse Kontakt Backup
- Navn: Lien Bruck
- Telefonnummer: +972 587487431
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Within-Individual Variability in Resting Metabolic Rate (RMR)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Minimal Detectable Change (MDC) in RMR
Tidsramme: 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
Tidsramme: 12 weeks
|
Assessment of variability in resting metabolic rate between participants based on repeated measurements.
|
12 weeks
|
|
Temporal Trends in RMR
Tidsramme: 12 weeks
|
Assessment of systematic changes in resting metabolic rate over time using repeated measurements across the study period.
|
12 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Yftach Prof. Gepner, Tel Aviv University
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 0012137-2
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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