- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Yftach Prof. Gepner
- Telefonnummer: +972 50-682-8501
- E-post: gepner@tauex.tau.ac.il
Studer Kontakt Backup
- Navn: Lien Bruck
- Telefonnummer: +972 587487431
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
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 studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Yftach Prof. Gepner, Tel Aviv University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 0012137-2
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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