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The Effect of Tea Breaks on Cerebrovascular Perfusion During Desk Work

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03953391
Recruitment Status : Completed
First Posted : May 16, 2019
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
Liverpool John Moores University
Information provided by (Responsible Party):
Unilever R&D

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.

Condition or disease Intervention/treatment Phase
Cerebrovascular Circulation Affect Other: Tea Other: Water Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomised, full cross-over study
Masking: Single (Outcomes Assessor)
Masking Description: Person doing the statistical analyses will blinded to the treatments
Primary Purpose: Other
Official Title: The Effect of Tea Breaks on Cerebrovascular Perfusion During Desk Work
Actual Study Start Date : April 30, 2019
Actual Primary Completion Date : June 24, 2019
Actual Study Completion Date : July 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
Experimental: Tea-water
Tea before water
Other: 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.

Other: Water
150 ml water is served to subjects once every hour. The water is consumed whilst being seated at their desks.

Experimental: Water-tea
Water before tea
Other: 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.

Other: Water
150 ml water is served to subjects once every hour. The water is consumed whilst being seated at their desks.




Primary Outcome Measures :
  1. Difference in cerebrovascular perfusion of tea versus water [ Time Frame: 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


Secondary Outcome Measures :
  1. Difference in cerebrovascular auto-regulation gain of tea versus water [ Time Frame: 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).


  2. Difference in cerebrovascular auto-regulation phase of tea versus water [ Time Frame: 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).


  3. Difference in cerebrovascular auto-regulation coherence of tea versus water [ Time Frame: 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).



Other Outcome Measures:
  1. Difference in PANAS of tea versus water [ Time Frame: 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).

  2. Difference in Bond-Lader of tea versus water [ Time Frame: 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.

  3. Difference in affect of tea versus water [ Time Frame: 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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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953391


Locations
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United Kingdom
John Moores University
Liverpool, United Kingdom
Sponsors and Collaborators
Unilever R&D
Liverpool John Moores University
Investigators
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Principal Investigator: Dick Thijssen, prof Liverpool John Moores University

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Responsible Party: Unilever R&D
ClinicalTrials.gov Identifier: NCT03953391     History of Changes
Other Study ID Numbers: REF-BEV-3235
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No