The Effect of Tea Breaks on Cerebrovascular Perfusion During Desk Work

NCT03953391 | Completed

• 1 other identifier: REF-BEV-3235
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Circulation; Affect

Outcome Measures

Primary Outcomes (1)

• Difference in cerebrovascular perfusion of tea versus water

  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.

Secondary Outcomes (3)

• Difference in cerebrovascular auto-regulation gain of tea versus water

  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

  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

  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 (3)

• Difference in PANAS of tea versus water

  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

  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

  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.

Study Arms (2)

Tea-water

EXPERIMENTAL

Tea before water

Other: Tea; Other: Water

Water-tea

EXPERIMENTAL

Water before tea

Other: Tea; Other: Water

Interventions

Tea OTHER

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.

Tea-water; Water-tea

Water OTHER

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

Tea-water; Water-tea

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unilever R&D: lead
• Liverpool John Moores University: collaborator

Study Sites (1)

John Moores University

Liverpool, United Kingdom

Location

MeSH Terms

Interventions

Tea; Water

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Dick Thijssen, prof

  Liverpool John Moores University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Person doing the statistical analyses will blinded to the treatments
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomised, full cross-over study

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: May 16, 2019
• Study Start: April 30, 2019
• Primary Completion: June 24, 2019
• Study Completion: July 15, 2019
• Last Updated: August 7, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)