Effect of Black Tea on Vascular Function

NCT01945970 | Completed Results

• 1 other identifier: REF-BEV-1134
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Epidemiological studies indicate that regular consumption of three cups of black tea per day reduces the risk of stroke or myocardial infarction. In a number of previous nutrition intervention studies tea has been shown to improve vascular function as assessed by Flow Mediated Dilation (FMD).

Conditions

Vascular Function

Keywords

Vascular function; Flow mediated dilation; Tea

Outcome Measures

Primary Outcomes (1)

• Flow Mediated Dilation, Acute-upon-chronic, Black Tea

  Flow mediated dilation (FMD) measurement included the following steps: * 1 minute base scan to measure the baseline diameter of artery (Resting stage) * 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease) * 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage) * When the artery had returned to baseline a second 1 minute scan was taken * 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject * 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation).

  From before consumption on day 1 to 2 hours post consumption on day 8.

Secondary Outcomes (5)

• Flow Mediated Dilation, Acute, Black Tea

  From before consumption on day 1 to 2 hours post consumption on day 1

• Flow Mediated Dilation, Chronic, Black Tea

  From before consumption day 1 to before consumption day 8.

• Flow Mediated Dilation, Acute-upon-chronic, Positive Control

  From before consumption on day 1 to 2 hours post consumption on day 8

• Flow Mediated Dilation, Acute, Positive Control

  From before consumption on day 1 to 2 hours post consumption on day 1

• Flow Mediated Dilation, Chronic, Positive Control

  From before consumption on day 1 to before consumption day 8

Other Outcomes (10)

• Systolic Blood Pressure, Black Tea

  From before consumption on day 1 to before consumption on day 8

• Diastolic Blood Pressure Black Tea

  From before consumption on day 1 to before consumption day 8

• Systolic Blood Pressure, Positive Control

  From before consumption (baseline) day 1 to before consumption day 8

Study Arms (3)

Black tea extract

EXPERIMENTAL

Spray dried aqueous extract of a representative batch of black tea

Other: Black tea extract

Positive control

ACTIVE COMPARATOR

Spray dried aqueous extract of a batch of tea extract that has shown to improve FMD previously

Other: Positive control

Placebo

PLACEBO COMPARATOR

Food grade colouring, artificial tea flavour and an amount of caffeine matched to the caffeine in the Black tea extract

Other: Placebo

Interventions

Black tea extract OTHER

Black tea extract

Black tea extract

Positive control OTHER

Positive control

Positive control

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Apparently healthy male volunteers with no history of cardiovascular disease
• Having body mass index (BMI) of between 18.0 and 30.0 kg/m2 (inclusive)
• Non-smokers (\> 2 years)
• Non-tea drinkers (less or equal 1 cup/week)
• Limited alcohol intake (less or equal 21 units/week)
• Systolic blood pressure less or equal 160 mmHg and/or diastolic blood pressure less or equal 100 mmHg at screening
• Brachial artery can be imaged using ultrasound and at screening FMD value is within the expected range as judged by the PI
• 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).

Sponsors & Collaborators

• Unilever R&D: lead
• Sprim Advanced Life Sciences: collaborator

Study Sites (1)

Azienda Ospedaliero-Universitaria Pisana, Centro di Farmacologia Clinicaper la Sperimentazione dei Farmaci

Pisa, Italy

Location

MeSH Terms

Interventions

Tea

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr Theo Mulder
• Organization: Unilever R&D Research Vlaardingen

theo.mulder@gmail.com

+31 10 460 8315

Study Officials

• Lorenzo Ghiadoni, MD

  University of Pisa, Internal medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: September 8, 2013
• First Posted: September 19, 2013
• Study Start: September 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 22, 2017
• Results First Posted: February 17, 2017

Record last verified: 2017-02

Locations

IT (1)