- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03953391
The Effect of Tea Breaks on Cerebrovascular Perfusion During Desk Work
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Liverpool, 영국
- John Moores University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Healthy males and females, age at screening > 18 and < 60 years;
- BMI > 18 and < 30 kg/m2
- Apparently healthy
- Agreeing to be informed about medically relevant personal test-results by a physician
- Informed consent signed
- Sedentary working individuals (≥6 hours desk work per day, ≥4 days per week)
Exclusion Criteria:
- Reported physical exercise ≥4 hours per week
- Taking medication (including food supplements and traditional medicines) which may interfere with study measurements, as judged by the PI
- Reported participation in another nutritional or biomedical trial (involving an intervention of at least 1 week) 3 months before the screening or during the study
- Reported participation in night shift work 2 weeks prior to screening or during the study. Night work is defined as working between midnight and 6.00 a.m.
- Reported consumption of > 14 units (female subjects) and > 21 units (male subjects) alcoholic drinks in a typical week.
- Reported use of any nicotine containing products in the 6 months preceding the study and during the study itself.
- If female, is pregnant (or has been pregnant during the last < 3 months ago) or will be planning pregnancy during the study period.
- If female, is lactating or has been lactating in the 6 weeks before screening and/or during the study period.
- Reported weight loss/gain (> 10%) in the last 6 months before the study.
- Being an employee of Unilever or an employee or a student working in RISES LJMU that is directly involved in this study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Tea-water
Tea before water
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Subjects walk to a nearby area and prepare a cup of 150 ml tea once every hour.
The tea is consumed whilst being seated at their desks.
150 ml water is served to subjects once every hour.
The water is consumed whilst being seated at their desks.
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실험적: Water-tea
Water before tea
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Subjects walk to a nearby area and prepare a cup of 150 ml tea once every hour.
The tea is consumed whilst being seated at their desks.
150 ml water is served to subjects once every hour.
The water is consumed whilst being seated at their desks.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Difference in cerebrovascular perfusion of tea versus water
기간: Immediately before and immediately after each of the two 6-hour interventions. The 'before' results will be added to the mixed model as a covariate.
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Cerebrovascular perfusion measured as middle cerebral artery velocity
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Immediately before and immediately after each of the two 6-hour interventions. The 'before' results will be added to the mixed model as a covariate.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Difference in cerebrovascular auto-regulation gain of tea versus water
기간: Immediately before and immediately after each of the two 6-hour interventions. The 'before' results will be added to the mixed model as a covariate.
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Dynamic cerebrovascular autoregulation is assessed via squat-stand manoeuvres performed to elicit oscillations in blood pressure within the high-pass filter frequency range (<0.20 Hz) of the cerebrovascular. Squat-stand cycles are performed at 0.2 Hz (2.5-seconds squatting, followed by 2.5-seconds standing) and at 0.1 Hz (5-seconds squatting, followed by 5-seconds standing) for 5-minutes each, separated by a 5-minute rest. Transfer function analysis is conducted on the beat-to-beat blood pressure and middle cerebral artery blood flow velocity mean signals to produce values of gain (damping effect of Cerebrovascular autoregulation on the magnitude of blood pressure oscillations). |
Immediately before and immediately after each of the two 6-hour interventions. The 'before' results will be added to the mixed model as a covariate.
|
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Difference in cerebrovascular auto-regulation phase of tea versus water
기간: Immediately before and immediately after each of the two 6-hour interventions. The 'before' results will be added to the mixed model as a covariate.
|
Dynamic cerebrovascular autoregulation is assessed via squat-stand manoeuvres performed to elicit oscillations in blood pressure within the high-pass filter frequency range (<0.20 Hz) of the cerebrovascular. Squat-stand cycles are performed at 0.2 Hz (2.5-seconds squatting, followed by 2.5-seconds standing) and at 0.1 Hz (5-seconds squatting, followed by 5-seconds standing) for 5-minutes each, separated by a 5-minute rest. Transfer function analysis is conducted on the beat-to-beat blood pressure and middle cerebral artery blood flow velocity mean signals to produce values of phase (temporal relationship between changes in blood pressure and middle cerebral artery blood flow velocity). |
Immediately before and immediately after each of the two 6-hour interventions. The 'before' results will be added to the mixed model as a covariate.
|
|
Difference in cerebrovascular auto-regulation coherence of tea versus water
기간: Immediately before and immediately after each of the two 6-hour interventions. The 'before' results will be added to the mixed model as a covariate.
|
Dynamic cerebrovascular auto-regulation is assessed via squat-stand manoeuvres performed to elicit oscillations in blood pressure within the high-pass filter frequency range (<0.20 Hz) of the cerebrovascular. Squat-stand cycles are performed at 0.2 Hz (2.5-seconds squatting, followed by 2.5-seconds standing) and at 0.1 Hz (5-seconds squatting, followed by 5-seconds standing) for 5-minutes each, separated by a 5-minute rest. Transfer function analysis is conducted on the beat-to-beat blood pressure and middle cerebral artery blood flow velocity mean signals to produce values of coherence (linearity of the relationship between the changes in middle cerebral artery blood flow velocity and blood pressure). |
Immediately before and immediately after each of the two 6-hour interventions. The 'before' results will be added to the mixed model as a covariate.
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Difference in PANAS of tea versus water
기간: Immediately before and immediately after each of the two 6-hour interventions. The 'before' results will be added to the mixed model as a covariate.
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Positive and Negative Affect Schedule (PANAS) questionnaire consisting of a list of ten positive and ten negative feelings and emotions.
Participants rate the extent to which they are feeling each emotion, on a scale from 1 (very slightly or not at all) to 5 (extremely).
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Immediately before and immediately after each of the two 6-hour interventions. The 'before' results will be added to the mixed model as a covariate.
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Difference in Bond-Lader of tea versus water
기간: Immediately before and immediately after each of the two 6-hour interventions. The 'before' results will be added to the mixed model as a covariate.
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Bond-Lader questionnaire: 16 adjective pairs with a 100mm line in between.
Three sub-scales will be calculated: Alertness, Contentedness and Calmness.
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Immediately before and immediately after each of the two 6-hour interventions. The 'before' results will be added to the mixed model as a covariate.
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Difference in affect of tea versus water
기간: Before (0) and at 1, 2, 3, 4 and 5 hours during tea and water interventions. Both dimensions will be tested in a repeated measures linear mixed model. The treatment effect is the difference in the least square means of tea versus water.
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Affect grid.
Two dimensional grid of 19x19 cells scoring pleasure and arousal
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Before (0) and at 1, 2, 3, 4 and 5 hours during tea and water interventions. Both dimensions will be tested in a repeated measures linear mixed model. The treatment effect is the difference in the least square means of tea versus water.
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Dick Thijssen, prof, Liverpool John Moores University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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 연구와 관련된 용어
기타 연구 ID 번호
- REF-BEV-3235
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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