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Not yet recruiting NCT07628764

Within-Individual Variability of Resting Metabolic Rate Over 12 Weeks

Observational Resting Metabolic Rate Energy Metabolism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Repeated Measurement of Resting Metabolic Rate.
Who it may be relevant to
Registry conditions: Resting Metabolic Rate, Energy Metabolism. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Within-Individual Variability of Resting Metabolic Rate Assessed Repeatedly Over 12 Weeks Using Whole-Room Calorimetry

Overview

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.

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.

Interventions

  • Other Repeated Measurement of Resting Metabolic Rate
    Repeated assessment of resting metabolic rate under standardized conditions; no intervention is administered.

Primary outcome measures

  • Within-Individual Variability in Resting Metabolic Rate (RMR) [Time frame: 12 weeks]
Secondary outcome measures (3)
  • Minimal Detectable Change (MDC) in RMR [Time frame: 12 weeks]
  • Between-Individual Variability in RMR [Time frame: 12 weeks]
  • Temporal Trends in RMR [Time frame: 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07628764 · 0012137-2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗