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Tea and Forearm Blood Flow

NCT ID: NCT02328339

Last Updated: 2015-08-31

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-08-31

Brief Summary

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The study will explore the benefit of tea for microcirculation. Subjects will consume tea ar a placebo matched for taste and appearance in a blinded cross over design.

Detailed Description

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Epidemiological studies indicate that regular consumption of black tea reduces the risk of cardiovascular diseases. Tea consumption can result in improvements in endothelial function of conduit arteries as measured by flow mediated dilation.

Less is known however about its effects in other vascular beds. The study will test the hypothesis that tea affects endothelial function in the muscle microcirculation. This will be done by assessment of forearm blood flow using venous occlusion plethysmography after consumption of black tea against or placebo in a randomised, full cross-over study in 20 healthy middle-aged to elderly subjects

Conditions

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Vascular Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Black tea

Approximately 400 mg total polyphenols in 240 ml hot water (loading dose; 2 hours before the start of measurements; t=0) and 130 mg total polyphenols in 120 ml hot water (maintenance dose just before start of the measurements; t=120 min)

Group Type EXPERIMENTAL

Tea

Intervention Type OTHER

Black tea infusion equivalent to approximately 530 mg total polyphenols expressed as gallic acid equivalents

Placebo

Caramel colour, maltodextrin and tea flavour in 240 ml hot water (2 hours before the start of measurements; t=0) and 120 ml hot water (maintenance dose just before start of the measurements; t=120 min)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo matched to tea with respect to taste and appearance

Interventions

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Tea

Black tea infusion equivalent to approximately 530 mg total polyphenols expressed as gallic acid equivalents

Intervention Type OTHER

Placebo

Placebo matched to tea with respect to taste and appearance

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Males and post menopausal (\> 1 years) females
* Aged ≥ 45 and ≤ 75 years
* Body mass index (BMI) of ≥ 18.0 and ≤ 35.0 kg/m2
* Judged to be in good health on the basis of medical history, physical examination and routine laboratory tests (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, glucose, highly sensitive C-reactive protein).
* Normal blood coagulation as assessed by routine lab tests

Exclusion Criteria

* Strenuous exercise \> 2 hours per week. Strenuous exercise is defined as exercise which induces sweating and causes sufficient breathlessness to limit conversation
* Current smoker or has stopped smoking less than 6 months before start of study
* Self reported alcohol intake of \> 21 units/week)
* Established cardiovascular disease or clinically significant arrhythmia
* Diabetes mellitus
* Blood pressure \> 160/100 mmHg
* Taking medication that might affect endothelial function (as judged by the PI)
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role collaborator

Unilever R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sean Roerink, Dr.

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

References

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Greyling A, Wolters TLC, de Bresser DM, Roerink SHPP, Riksen NP, Mulder TP, Rowson MJ, Hopman MT, Thijssen DHJ. The acute effect of black tea consumption on resistance artery endothelial function in healthy subjects. A randomized controlled trial. Clin Nutr ESPEN. 2018 Feb;23:41-47. doi: 10.1016/j.clnesp.2017.10.011. Epub 2017 Nov 8.

Reference Type DERIVED
PMID: 29460812 (View on PubMed)

Other Identifiers

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REF-BEV-1797

Identifier Type: -

Identifier Source: org_study_id