Investigating the Effects of Green Tea on Blood Viscosity
NCT ID: NCT06740448
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
35 participants
INTERVENTIONAL
2025-01-31
2025-05-31
Brief Summary
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Detailed Description
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Before confirmation, a screening visit will be undertaken where checks for regular haematocrit, blood pressure, plasma triglycerides, blood glucose and inflammatory markers and BMI will be taken. This will involve a 4.5 ml blood sample. Additionally, the research nurse will assess the potential participant's veins, and participants who do not have 2 'good' veins for giving blood will be excluded from the trial.
Following recruitment, participants will be asked to follow a set of criteria for the 24 hours prior to participating in the study. This will include, following a low polyphenol diet and not consuming any over the counter medication, caffeine or alcohol for 24 hours prior to participating. Participants will also be asked to attend fasted for 12 hours. Participants will also be asked to not take part in any vigorous/aerobic exercise in the 24 hours leading up to the study.
Following recruitment, and on arrival, participants will be asked to confirm they have followed the requirements for the previous 24 hours and full informed consent will be obtained from the participant. Participants will complete a spot urine test to measure osmolality as a measure of hydration. Participants will be asked to sit in a rested position for 15 min prior to each blood sample. Blood pressure will then be measured followed by a blood sample (17.5ml). The blood sample will be passed through the viscometer to assess whole blood and plasma viscosity and part of the blood sample will be used to measure haematocrit, inflammatory markers and blood lipids. The participant will then be given 200 mL green tea. They will be asked to consume this within 15 minutes. The intervention will be provided in an opaque cup with a lid on and the participant will be asked not to remove the lid so that the contents is not revealed to them. This will be followed by a low flavonoid breakfast. The same blood sample and urine test will then be taken at 2 hours and 8 hours after the start of consuming the drink, and these will be processed in the same way. A low flavonoid meal will also be provided between the 2- and 8-hour blood sample. A second visit will involve the exact same protocol; however, the participants will be given hot water as a control condition.
On the first of two visits, the participant will be asked to fill out a food frequency questionnaire. The order of green tea/control visits will be randomised and counterbalanced. In the 12-hours leading up to the visit, participants will be asked to consume 500 mL of water (a bottle will be provided). Throughout the visit, participants will be provided with unlimited water to drink and the total volume that has been consumed between each blood sample throughout the study will be recorded. On the second visit, the participant will be asked to replicate this amount.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
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Green Tea
200 mL green tea on first visit
Green Tea
200 mL Green Tea
Control (Hot Water)
200 mL hot water
Hot Water
200 mL hot water on first visit
Green Tea
200 mL Green Tea
Control (Hot Water)
200 mL hot water
Interventions
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Green Tea
200 mL Green Tea
Control (Hot Water)
200 mL hot water
Eligibility Criteria
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Inclusion Criteria
* Non-smoker Participants with at least 2 'good' veins for giving blood
Exclusion Criteria
* Participants on prescription medication for CVD or regularly taking blood thinning drugs such as aspirin.
* Participants with a history of CVD or CVD in immediate family/ high resting blood pressure
* Participants with any food allergies/intolerances
* Participants with a history of metabolic diseases/ high resting blood glucose
* Participants with high resting levels of inflammatory markers (CRP)
* Participants on hormone replacement therapy
* Participants with abnormal red blood cell count or low haemoglobin stores
65 Years
ALL
Yes
Sponsors
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Biotechnology and Biological Sciences Research Council
OTHER
Royal Berkshire NHS Foundation Trust
OTHER_GOV
University of Reading
OTHER
Responsible Party
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Jeremy Paul Edward Spencer
Professor
Locations
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Hugh Sinclaire Unit of Human Nutrition, Departmeant of Food and Nutrition, University of Reading
Reading, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Jeremy P E Spencer, PhD
Role: primary
Jeremy P E Spencer, PhD
Role: backup
Other Identifiers
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UREC 24/22
Identifier Type: -
Identifier Source: org_study_id