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OpenTrials
Completed

NCT Number: NCT02328339

Tea and Forearm Blood Flow

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.

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Key information

Conditions

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tea

Other

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

Placebo

Other

Placebo matched to tea with respect to taste and appearance

Primary outcomes

  1. Forearm blood flow response to acetylcholine

    Time frame: During acetylcholine infusion 120-140 min after first tea/placebo intake

    Does tea ingestion change mean forearm blood flow response to acetylcholine when compared to placebo

Secondary outcomes

  1. Forearm blood flow response to sodium nitropusside

    Time frame: During sodium nitropusside infusion 170-190 min after first tea/placebo intake

    Does tea ingestion change mean forearm blood flow response to sodium nitropusside when compared to placebo

  2. Forearm blood flow response to L-NMMA

    Time frame: During L-NMMA infusion 220-240 min after first tea/placebo intake

    Does tea ingestion change mean forearm blood flow response to L-NG-monomethyl Arginine (L-NMMA) when compared to placebo

Sponsors and collaborators

Lead sponsor

Unilever R&D

Industry

Collaborators

  • Radboud University Medical Center

Registry information

Official study title

Forearm Blood Flow Response to Acute Consumption of Black Tea

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 31, 2014
Registry last updated
Aug 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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