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N/A Completed N=30 Randomized Quadruple-blind Other

Efficacy of Brooke Bond Black Tea Extract on Flow Mediated Dilation in Indian Males

Healthy
Source: ClinicalTrials.gov NCT01561300 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: 'Acute-upon-chronic Effect' of Tea vs Control — 8.03; 9.03 percentage of change in diameter — p=0.09

Summary

This study examines the effect of 1800 mg/day standardized Brooke Bond black tea extract, equivalent to 400 mg flavonoids, on Flow Mediated Dilation in healthy Indian males.

Outcome Measures

OutcomeResultp-value
PRIMARY
'Acute-upon-chronic Effect' of Tea vs Control
8.03; 9.03 0.09
SECONDARY
Acute Effect of Tea vs Control
8.44; 8.82 0.70
SECONDARY
Chronic Effect of Tea vs Control
9.19; 9.39 0.66

Eligibility Criteria

Inclusion Criteria

  • Male volunteers aged between >\_30 \_ \_18 and \_ \_140 and >\_100 mmHg and diastolic blood pressure 70 mmHg
  • Subjects who consume \_ \_ 2 cups per day)
  • Apparently healthy, with no reported medical condition which might affect the assessment as judged by the study physician or/and PI
  • No prescribed medical treatment that may affect study parameters as judged by the Study Physician
  • Subject willing to abstain from alcohol on day before and on the day of assessment
  • Willing to sign the informed consent form

Exclusion Criteria

  • Smokers and/or tobacco chewers
  • Those who consume regular alcohol (> 160 ml of alcohol per week)
  • Reported intense sport activities > 10h/week
  • Participating in any other clinical study concurrently or if participated in any study during 2 months preceding the screening visit
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01561300). 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. Informational only — not medical advice.

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