NCT02273323

Brief Summary

Research indicate that people who regularly drink tea have a reduced risk of stroke or heart disease. In a number of studies in which people that normally do not drink showed that their blood vessels function improved when the drunk tea. The current study tests whether a specific black tea improves vessel function in non-tea drinking hypertensive subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

February 15, 2017

Completed
Last Updated

February 15, 2017

Status Verified

December 1, 2016

Enrollment Period

1 year

First QC Date

October 21, 2014

Results QC Date

October 11, 2016

Last Update Submit

December 21, 2016

Conditions

Vascular Function

Keywords

Flow mediated dilationteablood pressure

Outcome Measures

Primary Outcomes (1)

  • Flow Mediated Dilation

    Flow mediated dilation (FMD) of the brachial artery was measured using vascular ultra sound and automated edge detection software: * 1 minute baseline scan to measure the baseline diameter of artery * 5 minutes of forearm occlusion at 250±30 mmHg, below the elbow (2-5 cm from antecubital crease) * 4 minutes FMD scan, which started immediately after release of occlusion Percentage FMD was calculated as the maximum increase in diameter after cuff release relative to the baseline diameter

    Before and 2 hours after test product intake

Secondary Outcomes (5)

  • Endothelium-independent Vasodilation

    2.5 hours after test product intake

  • Systolic Blood Pressure Supine

    Before and 110 minutes after test product intake

  • Diastolic Blood Pressure Supine

    Before and 110 minutes after test product intake

  • Systolic Blood Pressure Sitting

    Before and 90 minutes after test product intake

  • Diastolic Blood Pressure Sitting

    Before and 90 minutes after test product intake

Study Arms (2)

Tea

EXPERIMENTAL

Black tea

Other: Tea

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

TeaOTHER

Single dose of black tea infusion containing approximately 400 mg flavonoids (expressed as gallic acid equivalents) with added sugar.

Tea
PlaceboOTHER

Placebo: tea flavour, colouring and sugar

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and post menopausal (\> 1 year) females, not on hormone replacement therapy
  • Aged \>18 and \< 65 years
  • Body mass index (BMI) of \>=18.0 and =\<35.0 kg/m2
  • Hypertension as previously diagnosed by primary care or hospital physician.
  • If untreated, office BP between 140/90 mmHg and 160/100 mmHg on screening
  • If treated, a controlled blood pressure (\<160/100) on stable medication for at least 4 weeks

You may not qualify if:

  • Tea drinkers: having typically consumed \> 1 cup of black tea per week.
  • 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 other than hypertension
  • Clinically significant arrhythmia
  • Diabetes mellitus
  • Chronic Kidney Disease \> stage 2
  • year cardiovascular risk equivalent to 20% or greater using the QRisk2 calculator
  • Abnormality of laboratory blood tests considered clinically significant
  • Any other significant intercurrent condition/disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept Clinical Pharmacology/CRF, St Thomas Hospital

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Interventions

Tea

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Results Point of Contact

Title
Theo Mulder
Organization
Unilever R&D Vlaardingen
theo.mulder@unilever.com
+31 10 460 8315

Study Officials

  • Phillip Chowienczyk, Professor

    Dept Clinical Pharmacology/CRF, St Thomas Hospital, London UK

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

October 21, 2014

First Posted

October 23, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

February 15, 2017

Results First Posted

February 15, 2017

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)