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The Effect of Tea on Vascular Function and Insulin Sensitivity

Primary Purpose

Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Green tea
Placebo tea
Sponsored by
Liverpool John Moores University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Insulin Resistance focused on measuring tea, cardiovascular, vascular, metabolism, microcirculation, physical inactivity, polyphenols, conduit artery, endothelial function, cerebrovascular, insulin sensitivity

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Research Institute for Sport and Exercise Sciences (RISES), Liverpool John Moores University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active (green) tea

Placebo tea

Arm Description

Tea to be ingested 3 times per day for 7 days.

Tea to be ingested 3 times per day for 7 days.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 17, 2016
Last Updated
August 23, 2017
Sponsor
Liverpool John Moores University
Collaborators
Unilever R&D
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1. Study Identification

Unique Protocol Identification Number
NCT02777853
Brief Title
The Effect of Tea on Vascular Function and Insulin Sensitivity
Official Title
Can Tea Prevent Impairments in Vascular Function and Insulin Sensitivity Induced by 7-days Physical Inactivity and Overfeeding in Healthy Men
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Liverpool John Moores University
Collaborators
Unilever R&D

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
Keywords
tea, cardiovascular, vascular, metabolism, microcirculation, physical inactivity, polyphenols, conduit artery, endothelial function, cerebrovascular, insulin sensitivity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active (green) tea
Arm Type
Experimental
Arm Description
Tea to be ingested 3 times per day for 7 days.
Arm Title
Placebo tea
Arm Type
Placebo Comparator
Arm Description
Tea to be ingested 3 times per day for 7 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Green tea
Other Intervention Name(s)
Camillia sinesis
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo tea
Intervention Description
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.
Primary Outcome Measure Information:
Title
Insulin sensitivity
Description
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.
Time Frame
Post 7 day intervention
Secondary Outcome Measure Information:
Title
Vascular function
Description
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.
Time Frame
Post 7 day intervention

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsty A Woodward, BSc
Organizational Affiliation
Liverpool John Moores University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Institute for Sport and Exercise Sciences (RISES), Liverpool John Moores University
City
Liverpool
ZIP/Postal Code
L3 3AF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Tea on Vascular Function and Insulin Sensitivity

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