Effect of black tea consumption on flow mediated dilatation: A randomized, placebo controlled, double blind, crossover trial.

Not Applicable

• Conditions: Healthy volunteers

• Registration Number: JPRN-UMIN000011889
• Lead Sponsor: Shizuoka Industrial Foundation

Brief Summary

According to the protocol, all 15 subjects were conducted the present study. The data of 14 subjects except one subject who infringed of the exclusion criterion were analyzed. FMD, as primary end point, was significantly high level in test drink group compared with placebo group 240 min after ingestion. After calculation of the 95 percent confidence limit using before treatment value of the al subject, the data of 10 subject whose FMD was within the 95 percent confidence limit before treatment were analyzed, FMD was significantly elevated 120 min after ingestion of test drink compared with before treatment. Nitrate and nitrite or catecholamine levels in blood, as secondary end points, were not observed any difference between experimental groups. Systolic and diastolic blood pressure were significantly increased 120 and 240 min after ingestion of test drink compared with before treatment.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

1) Subjects who is currently taking medication for hypertension 2) Subjects who take any supplement, functional food, tea or chocolate during the test period. 3) Subjects who drink more than 25 g/day of alcohol 4) Subjects who has sports habit. 5) Subjects with diabetes, renal disease, or hepatic disease 6) Subjects with a diagnosis of familial hypertension 7) Subjects with any history for alimentary allergy 8) Subjects who is pregnant, plan to get pregnant between trial period, is during lactation. 9) Subjects who, in the opinion of the investigator, are not likely to participate in the study for any reason

Study & Design

• Study Type: Interventional
• Study Design: Not specified