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- Title
The efficacy of resveratrol in controlling hypertension: study protocol for a randomized, crossover, double-blinded, placebo-controlled trial.
- Authors
Movahed, Ali; Ostovar, Afshin; Iranpour, Daryoush; Thandapilly, Sijo Joseph; Raj, Pema; Lieben Louis, Xavier; Smoliga, James Michael; Netticadan, Thomas; Louis, Xavier Lieben
- Abstract
<bold>Background: </bold>Hypertension is a global health concern for which novel treatment strategies are necessary. The aim of this study is to evaluate the efficacy of resveratrol (trans-3, 5, 4'-trihydroxystilbene, a polyphenol present in grapes) in controlling blood pressure in participants diagnosed with prehypertension and stage 1 hypertension.<bold>Methods/design: </bold>In a randomized, crossover, double-blinded, placebo-controlled study, 50 participants with prehypertension (diastolic blood pressure and systolic blood pressure, 80-89 mmHg and 120-139 mmHg, respectively) and 50 participants with stage 1 hypertension (diastolic and systolic, 90-99 mmHg and 140-159 mmHg, respectively) will be assigned to receive resveratrol (99 % pure, from Biotivia Longevity Bioceuticals LLC Company, USA, in 500 mg capsules, twice daily for 4 weeks, orally) or placebo (500 mg neutral microcellulose capsules, twice daily for 4 weeks) in a 2 × 2 crossover design (4 weeks treatment-4 weeks washout-4 weeks treatment). The blood pressure of each participant will be recorded (a mean of two times within a 15-minute interval) every week during the study. The participants in the prehypertensive group will not receive any medication, while those in the stage 1 hypertensive group will continue to receive their routine medications during the study. Blood samples will be taken from all groups and examined for various biochemical parameters.<bold>Discussion: </bold>This trial will help to establish whether resveratrol is an effective antihypertensive agent in prehypertensive and stage 1-hypertensive patients. The trial outcome will provide novel insight into the clinical efficacy of resveratrol and provide valuable information for conducting future clinical studies with resveratrol.<bold>Trial Registration: </bold>Iranian Registry of Clinical Trials, IRCT201407078129N7. Registered on 15 August 2014.
- Subjects
RESVERATROL; CARDIOVASCULAR disease diagnosis; HYPERTENSION; BLOOD pressure measurement; POLYPHENOLS; RANDOMIZED controlled trials; COMPARATIVE studies; CROSSOVER trials; RESEARCH methodology; MEDICAL cooperation; RESEARCH protocols; HEALTH outcome assessment; RESEARCH; SAMPLE size (Statistics); STILBENE; EVALUATION research; BLIND experiment; THERAPEUTICS
- Publication
Trials, 2016, Vol 17, p1
- ISSN
1745-6215
- Publication type
journal article
- DOI
10.1186/s13063-016-1426-x