Clinical trial NCT03953391: The Effect of Tea Breaks on Cerebrovascular Perfusion During Desk Work
Official title: The Effect of Tea Breaks on Cerebrovascular Perfusion During Desk Work
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Circulation
Affect
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
Collaborators: name: Liverpool John Moores University
First posted: 2019-05-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised, full cross-over study
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Difference in cerebrovascular perfusion of tea versus water
timeFrame: 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.
Secondary outcomes:
measure: Difference in cerebrovascular auto-regulation gain of tea versus water
timeFrame: 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.
measure: Difference in cerebrovascular auto-regulation phase of tea versus water
timeFrame: 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.
measure: Difference in cerebrovascular auto-regulation coherence of tea versus water
timeFrame: 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.
Other outcomes:
measure: Difference in PANAS of tea versus water
timeFrame: 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.
measure: Difference in Bond-Lader of tea versus water
timeFrame: 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.
measure: Difference in affect of tea versus water
timeFrame: 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.
Locations:
city: Liverpool
country: United Kingdom
facility: John Moores University
Study officials:
affiliation: Liverpool John Moores University
name: Dick Thijssen, prof
role: PRINCIPAL_INVESTIGATOR
References: