N/A
N=30
Flow Mediated Dilation in Response to Black Tea
Vascular Function
Bottom Line
View on ClinicalTrials.gov: NCT02273323 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: Flow Mediated Dilation — 5.24; 5.02; 6.05; 5.74 percentage of change in diameter — p=0.43
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tea (Other); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Unilever R&D
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Flow Mediated Dilation |
5.24; 5.02; 6.05; 5.74 | 0.43 |
| SECONDARY Endothelium-independent Vasodilation |
12.1; 11.4 | 0.20 |
| SECONDARY Systolic Blood Pressure Supine |
135.5; 138.1; 145.0; 147.2 | — |
| SECONDARY Diastolic Blood Pressure Supine |
85.1; 85.7; 88.9; 89.5 | — |
| SECONDARY Systolic Blood Pressure Sitting |
134.7; 137.2; 146.4; 148.5 | — |
| SECONDARY Diastolic Blood Pressure Sitting |
86.1; 87.7; 90.7; 89.4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Males and post menopausal (> 1 year) females, not on hormone replacement therapy
- Aged >18 and =18.0 and = 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
- 10-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
Data sourced from ClinicalTrials.gov (NCT02273323). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.