- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03953391
The Effect of Tea Breaks on Cerebrovascular Perfusion During Desk Work
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Liverpool, Det Forenede Kongerige
- John Moores University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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.
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Difference in cerebrovascular perfusion of tea versus water
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Difference in cerebrovascular auto-regulation gain of tea versus water
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Difference in PANAS of tea versus water
Tidsramme: 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.
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Difference in Bond-Lader of tea versus water
Tidsramme: 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.
|
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
Tidsramme: 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
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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.
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Dick Thijssen, prof, Liverpool John Moores University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- REF-BEV-3235
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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