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The Effect of Tea Breaks on Cerebrovascular Perfusion During Desk Work

6. srpna 2019 aktualizováno: Unilever R&D
Sedentary behaviour of healthy subjects may have a detrimental impact on cerebral blood flow as well as cognitive measures related to mood and alertness. In this study we focus on the impact of leaving the desk to consume a cup of tea at regular intervals during a sedentary working day.

Přehled studie

Postavení

Dokončeno

Intervence / Léčba

Detailní popis

Prolonged desk work has detrimental impact on cerebral blood flow as well as cognitive measures related to mood and alertness caused. These effects might be prevented by taking short breaks with physical activity. Usually, desk workers have short breaks during office times for either a visit to the restroom or to enjoy for a moment a (hot) drink. Consumption of tea has been associated with benefits related to attention, alertness, mood and creativity. This study focuses on the impact of physically leaving the desk to prepare and consume a cup of tea at regular intervals during a sedentary working day.

Typ studie

Intervenční

Zápis (Aktuální)

20

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 60 let (Dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Jiný
  • Přidělení: Randomizované
  • Intervenční model: Crossover Assignment
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Experimentální: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Difference in cerebrovascular perfusion of tea versus water
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Difference in cerebrovascular auto-regulation gain of tea versus water
Časové okno: 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
Časové okno: 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
Časové okno: 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.

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Difference in PANAS of tea versus water
Časové okno: 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
Časové okno: 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
Časové okno: 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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Vyšetřovatelé

  • Vrchní vyšetřovatel: Dick Thijssen, prof, Liverpool John Moores University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

30. dubna 2019

Primární dokončení (Aktuální)

24. června 2019

Dokončení studie (Aktuální)

15. července 2019

Termíny zápisu do studia

První předloženo

24. dubna 2019

První předloženo, které splnilo kritéria kontroly kvality

14. května 2019

První zveřejněno (Aktuální)

16. května 2019

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

7. srpna 2019

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

6. srpna 2019

Naposledy ověřeno

1. srpna 2019

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • REF-BEV-3235

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

Ne

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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