Affect Clinical Trial
Official title:
The Effect of Tea Breaks on Cerebrovascular Perfusion During Desk Work
Verified date | August 2019 |
Source | Unilever R&D |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | July 15, 2019 |
Est. primary completion date | June 24, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | John Moores University | Liverpool |
Lead Sponsor | Collaborator |
---|---|
Unilever R&D | Liverpool John Moores University |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Difference in PANAS of tea versus water | 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. | |
Other | Difference in Bond-Lader of tea versus water | 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. | |
Other | Difference in affect 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. | |
Primary | 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 | Difference in cerebrovascular auto-regulation gain of tea versus water | 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. | |
Secondary | Difference in cerebrovascular auto-regulation phase of tea versus water | 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. | |
Secondary | Difference in cerebrovascular auto-regulation coherence of tea versus water | 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. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04053686 -
An Intervention to Reduce Prolonged Sitting in Police Staff
|
N/A | |
Completed |
NCT04013451 -
The Kiss of Kindness Study II
|
N/A | |
Completed |
NCT03221985 -
ESM Pilot: Mobile Phones and Psychology
|
N/A | |
Completed |
NCT02560792 -
Tailored Activity Goals - an Exercise Prescription Study
|
N/A | |
Completed |
NCT04558411 -
Brief, Scaleable Intervention for Coronavirus (COVID-19) Mental Health Sequelae in College Students
|
N/A | |
Completed |
NCT03190135 -
Evaluation of the BOKS Before-school Physical Activity Program
|
N/A | |
Completed |
NCT01825681 -
Life Enhancing Activities for Family Caregivers
|
N/A | |
Completed |
NCT01965795 -
Whole Coffee Fruit Concentrate Pilot Study 1
|
N/A | |
Completed |
NCT04884438 -
Intervention for the Promotion of Gratitude
|
N/A | |
Active, not recruiting |
NCT05889078 -
The Effects of Walking in Nature (vs. an Urban Setting) on the Wellbeing of Postsecondary Students.
|
N/A | |
Completed |
NCT04935099 -
The Effects of a Single Dose of Wild Blueberries on Mood and Cognition in Healthy Young Adults
|
N/A | |
Completed |
NCT02853760 -
Affective Responses in Mountain Hiking
|
N/A | |
Completed |
NCT01997008 -
Optimizing Resilience and Coping in HIV Via Internet Delivery
|
N/A | |
Active, not recruiting |
NCT03779269 -
Effect of Preksha Meditation on Cognitive Abilities and Pulmonary Function in Students
|
N/A | |
Completed |
NCT05462977 -
Rhythmically Entrained Exercise in Community-Dwelling Older Adults
|
N/A | |
Completed |
NCT04287374 -
The Effects of Online Single-Session Interventions on College Student Well-being
|
N/A | |
Completed |
NCT04728958 -
Reflective Tasks With Healthcare Workers During COVID-19
|
N/A | |
Completed |
NCT05619419 -
Study of Affect Induction for Lab Induced Pain in Healthy Undergraduates
|
N/A | |
Completed |
NCT03475836 -
Cognitive Effects of Mint Essential Oil
|
N/A | |
Recruiting |
NCT04469790 -
Effects of Multi-day Interruptions in Sitting on Type 2 Diabetes-relevant Outcomes in Children
|
N/A |