Tea and Forearm Blood Flow

NCT02328339 | Completed

• 1 other identifier: REF-BEV-1797
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Vascular Function

Outcome Measures

Primary Outcomes (1)

• Forearm blood flow response to acetylcholine

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

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

Secondary Outcomes (2)

• Forearm blood flow response to sodium nitropusside

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

• Forearm blood flow response to L-NMMA

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

Study Arms (2)

Black tea

EXPERIMENTAL

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)

Other: Tea

Placebo

PLACEBO COMPARATOR

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)

Other: Placebo

Interventions

Tea OTHER

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

Black tea

Placebo OTHER

Placebo matched to tea with respect to taste and appearance

Placebo

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Unilever R&D: lead
• Radboud University Medical Center: collaborator

Related Publications (1)

• 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.

  PMID: 29460812 DERIVED

MeSH Terms

Interventions

Tea

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Sean Roerink, Dr.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2014
• First Posted: December 31, 2014
• Study Start: January 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 31, 2015

Record last verified: 2015-08