- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02777853
The Effect of Tea on Vascular Function and Insulin Sensitivity
August 23, 2017 updated by: Kirsty Woodward, Liverpool John Moores University
Can Tea Prevent Impairments in Vascular Function and Insulin Sensitivity Induced by 7-days Physical Inactivity and Overfeeding in Healthy Men
The aim of this research is to explore changes in peripheral/cerebrovascular function and insulin sensitivity after a 7-day combination of physical activity reduction (-50% steps per day) and overfeeding (+50% kcal per day, comprising 65% fat) in healthy male volunteers, and examine whether daily intake of tea can prevent such changes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The aim of this study is to explore the impact of a 7-day 'unhealthy' lifestyle that combines physical activity reduction (-50% steps per day) and overfeeding (+50% kcal per day, comprising 65% fat) on peripheral (conduit artery and skin microvessels) and cerebrovascular function and insulin sensitivity in healthy male participants.
Moreover, the investigators will explore whether the detrimental impact of this lifestyle can be mitigated by daily tea consumption (equivalent to 6 cups/day).
To explore this hypothesis, the investigators will perform measurements of these parameters before and after 7-days of reduced physical activity and overfeeding, with and without the combination of daily tea ingestion.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Liverpool, United Kingdom, L3 3AF
- Research Institute for Sport and Exercise Sciences (RISES), Liverpool John Moores University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Aged 18-55 years
- Male
- Habitually active (>8,000 steps/day)
- Healthy
Exclusion Criteria:
- Smokers
- Medical history of cardiovascular/metabolic disease
- Family history of cardiovascular disease (first degree relatives)
- On medication known to influence the cardiovascular system
- BMI of <18 or >30 kg/m2
- Known food allergies or special dietary requirements
- Vaccination (<1 week) due to induced systemic inflammatory reaction
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active (green) tea
Tea to be ingested 3 times per day for 7 days.
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The intervention product is regular green tea brewed with hot water in a large quantity.
The tea obtained is dried and the powder, with added sugar, is distributed over sealed aluminium sachets (1 gram of powder per sachet).
The product has been cleared for consumption by Unilever's Microbiology Department and the independent Safety and Environmental Assurance Centre of Unilever.
Other Names:
|
Placebo Comparator: Placebo tea
Tea to be ingested 3 times per day for 7 days.
|
A product of similar colour and taste, but not the presumed actives of tea (polyphenols), is used as placebo.
The product has been cleared for consumption by Unilever's Microbiology Department and the independent Safety and Environmental Assurance Centre of Unilever.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insulin sensitivity
Time Frame: Post 7 day intervention
|
This will be measured following a carbohydrate-rich meal tolerance test (MTT) after an overnight fast, combined with regular venous blood sampling of insulin and glucose.
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Post 7 day intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vascular function
Time Frame: Post 7 day intervention
|
Peripheral vascular function will be measured via endothelial-dependent flow-mediated dilation (FMD) of the brachial and femoral arteries, with microcirculatory function being assessed using local thermal hyperaemia and laser Doppler flowmetry (LDF), in addition to full-field laser perfusion imaging (FLPI).
Cerebrovascular function will be examined via transcranial Doppler.
|
Post 7 day intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kirsty A Woodward, BSc, Liverpool John Moores University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2016
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
July 1, 2017
Study Registration Dates
First Submitted
May 17, 2016
First Submitted That Met QC Criteria
May 18, 2016
First Posted (Estimate)
May 19, 2016
Study Record Updates
Last Update Posted (Actual)
August 24, 2017
Last Update Submitted That Met QC Criteria
August 23, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Greenshield16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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