- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Yftach Prof. Gepner
- 전화번호: +972 50-682-8501
- 이메일: gepner@tauex.tau.ac.il
연구 연락처 백업
- 이름: Lien Bruck
- 전화번호: +972 587487431
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Within-Individual Variability in Resting Metabolic Rate (RMR)
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Minimal Detectable Change (MDC) in RMR
기간: 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
기간: 12 weeks
|
Assessment of variability in resting metabolic rate between participants based on repeated measurements.
|
12 weeks
|
|
Temporal Trends in RMR
기간: 12 weeks
|
Assessment of systematic changes in resting metabolic rate over time using repeated measurements across the study period.
|
12 weeks
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Yftach Prof. Gepner, Tel Aviv University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .