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The Effect of Tea Breaks on Cerebrovascular Perfusion During Desk Work

6 sierpnia 2019 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Rzeczywisty)

20

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 60 lat (Dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Inny
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie krzyżowe
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Eksperymentalny: 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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Difference in cerebrovascular perfusion of tea versus water
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Difference in cerebrovascular auto-regulation gain of tea versus water
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Difference in PANAS of tea versus water
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Śledczy

  • Główny śledczy: Dick Thijssen, prof, Liverpool John Moores University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

30 kwietnia 2019

Zakończenie podstawowe (Rzeczywisty)

24 czerwca 2019

Ukończenie studiów (Rzeczywisty)

15 lipca 2019

Daty rejestracji na studia

Pierwszy przesłany

24 kwietnia 2019

Pierwszy przesłany, który spełnia kryteria kontroli jakości

14 maja 2019

Pierwszy wysłany (Rzeczywisty)

16 maja 2019

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

7 sierpnia 2019

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

6 sierpnia 2019

Ostatnia weryfikacja

1 sierpnia 2019

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • REF-BEV-3235

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

Nie

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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