N/A
N=30
Effect of Black Tea on Vascular Function
Vascular Function
Bottom Line
View on ClinicalTrials.gov: NCT01945970 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: Flow Mediated Dilation, Acute-upon-chronic, Black Tea — 4.24; 4.48; 4.49; 4.87 percentage of flow mediated dilation — p=0.36
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Black tea extract (Other); Positive control (Other); Placebo (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Male
- Sponsor
- Unilever R&D
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Flow Mediated Dilation, Acute-upon-chronic, Black Tea |
4.24; 4.48; 4.49; 4.87 | 0.36 |
| SECONDARY Flow Mediated Dilation, Acute, Black Tea |
4.24; 4.48; 4.50; 4.13 | 0.18 |
| SECONDARY Flow Mediated Dilation, Chronic, Black Tea |
4.24; 4.48; 3.90; 4.84 | 0.014 sig |
| SECONDARY Flow Mediated Dilation, Acute-upon-chronic, Positive Control |
3.28; 4.48; 4.21; 4.87 | 0.22 |
| SECONDARY Flow Mediated Dilation, Acute, Positive Control |
3.28; 4.48; 4.06; 4.13 | 0.09 |
| SECONDARY Flow Mediated Dilation, Chronic, Positive Control |
3.28; 4.48; 4.20; 4.84 | 0.32 |
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).
Eligibility Criteria
Inclusion Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT01945970). 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.