Insulin ResistanceNCT02777853
The Effect of Tea on Vascular Function and Insulin Sensitivity
A study testing Green tea in people with Insulin Resistance, run by Liverpool John Moores University at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Green tea
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-55 years
- Male
- Habitually active (>8,000 steps/day)
- Healthy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Research Institute for Sport and Exercise Sciences (RISES), Liverpool John Moores University
Liverpool, L3 3AF
About this study
Official title: 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.
Read the 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.
- Conditions
- Insulin Resistance
- Being tested
- Green tea, Placebo tea
- Keywords
- tea, cardiovascular, vascular, metabolism, microcirculation, physical inactivity, polyphenols, conduit artery, endothelial function, cerebrovascular, insulin sensitivity
- Medical subject headings
- Insulin Resistance, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green teaDietary supplement
Also called Camillia sinesis
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.
Placebo teaDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Active (green) tea | Experimental | Tea to be ingested 3 times per day for 7 days. Receives: Dietary Supplement: Green tea |
| Placebo tea | Placebo comparator | Tea to be ingested 3 times per day for 7 days. Receives: Dietary Supplement: Placebo tea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
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.
Measured: Post 7 day intervention
Secondary outcomes (1)
Vascular function
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.
Measured: Post 7 day intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Collaborators
- Unilever R&D
- Responsible party
- Principal investigator, Kirsty Woodward, Liverpool John Moores University
- Investigators
- Kirsty A Woodward, BSc, Principal investigator, Liverpool John Moores University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777853
- Sponsor's protocol ID
- Greenshield16
- Status last verified
- Aug 2017
- First submitted
- 17 May 2016
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Tea Prevent Impairments in Vascular Function and Insulin Sensitivity Induced by 7-days Physical Inactivity and Overfeeding in Healthy Men
- ClinicalTrials.gov ID
- NCT02777853
- Acronym / sponsor ID
- Greenshield16
- Conditions
- Insulin Resistance
- Keywords
- tea, cardiovascular, vascular, metabolism, microcirculation, physical inactivity, polyphenols, conduit artery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Collaborators
- Unilever R&D
- Study start
- May 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 19 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active (green) tea | Experimental | Dietary Supplement: Green teaTea to be ingested 3 times per day for 7 days. |
| Placebo tea | Placebo comparator | Dietary Supplement: Placebo teaTea to be ingested 3 times per day for 7 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 18-55 years
- Male
- Habitually active (>8,000 steps/day)
- Healthy
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Green teaAlso: Camillia sinesisThe 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. | Dietary supplement | Active (green) tea |
| Placebo teaA 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. | Dietary supplement | Placebo tea |
Primary outcome
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.
1 secondary outcome
Vascular function
Time frame: Post 7 day intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsty A Woodward, BSc principal investigator
Liverpool John Moores University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Green tea in people with Insulin Resistance, run by Liverpool John Moores University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: Post 7 day intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2017.