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The Effect of Tea Breaks on Cerebrovascular Perfusion During Desk Work

6 agosto 2019 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

20

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Liverpool, Regno Unito
        • John Moores University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 60 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Sperimentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Difference in cerebrovascular perfusion of tea versus water
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Difference in cerebrovascular auto-regulation gain of tea versus water
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Difference in PANAS of tea versus water
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Investigatori

  • Investigatore principale: Dick Thijssen, prof, Liverpool John Moores University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

30 aprile 2019

Completamento primario (Effettivo)

24 giugno 2019

Completamento dello studio (Effettivo)

15 luglio 2019

Date di iscrizione allo studio

Primo inviato

24 aprile 2019

Primo inviato che soddisfa i criteri di controllo qualità

14 maggio 2019

Primo Inserito (Effettivo)

16 maggio 2019

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 agosto 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 agosto 2019

Ultimo verificato

1 agosto 2019

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • REF-BEV-3235

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

No

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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