The Effect of Tea Breaks on Cerebrovascular Perfusion During Desk Work
調査の概要
詳細な説明
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Liverpool、イギリス
- John Moores University
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:他の
- 割り当て:ランダム化
- 介入モデル:クロスオーバー割り当て
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Tea-water
Tea before water
|
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.
|
|
実験的:Water-tea
Water before tea
|
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.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Difference in cerebrovascular perfusion of tea versus water
時間枠: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.
|
Cerebrovascular perfusion measured as middle cerebral artery 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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Difference in cerebrovascular auto-regulation gain of tea versus water
時間枠: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 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.
|
|
Difference in cerebrovascular auto-regulation phase of tea versus water
時間枠: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
時間枠: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.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Difference in PANAS of tea versus water
時間枠: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.
|
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).
|
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 Bond-Lader of tea versus water
時間枠: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.
|
Bond-Lader questionnaire: 16 adjective pairs with a 100mm line in between.
Three sub-scales will be calculated: Alertness, Contentedness and Calmness.
|
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 affect of tea versus water
時間枠: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.
|
Affect grid.
Two dimensional grid of 19x19 cells scoring pleasure and arousal
|
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.
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Dick Thijssen, prof、Liverpool John Moores University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- REF-BEV-3235
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。