Effect of Grape Seed Extract on Blood Pressure
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|ClinicalTrials.gov Identifier: NCT00869193|
Recruitment Status : Completed
First Posted : March 25, 2009
Last Update Posted : August 28, 2009
|Condition or disease||Intervention/treatment||Phase|
|Elevated Blood Pressure||Dietary Supplement: Grape seed extract Dietary Supplement: Microcrystalline cellulose (placebo)||Not Applicable|
Background: High blood pressure is a major risk factor for morbidity and mortality from stroke, heart disease, and end-stage renal disease. Several studies have shown that dietary polyphenols derived from fruits and vegetables (including those from grape products) can lower blood pressure in both normotensive and hypertensive subjects.
Study objectives: Primary objective: To study, in subjects with elevated blood pressure levels, the effects of grape seed extract high in polyphenols, on daytime ambulatory systolic and diastolic blood pressure (SBP and DBP, respectively). Secondary objective: To explore mechanistic pathways responsible for the blood pressure lowering efficacy in case a blood pressure lowering effect is shown.
Study population: Each treatment group will consist of 35 men and postmenopausal women (35-75 years of age) with daytime SBP between 120 and 159 mmHg. The total number of subjects will be 70.
Study design: This study will have a randomized, double-blind, placebo-controlled parallel design with 2 treatments, a 1-week run-in period, and an 8-week intervention period. The 2 treatments will consist of placebo capsules and capsules with grape seed extract.
Study outcomes: Daytime ambulatory blood pressure (ABP) will be measured every 20 minutes for 2 x 12 hours at baseline and 2 x 12 hours at the end of intervention. Furthermore, before and after the intervention period, 24-hour urine will be collected and 2 blood samples will be taken in order to investigate mechanistic pathways and platelet function.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Grape Seed Extract High in Polyphenols on Blood Pressure in Subjects With Elevated Blood Pressure Levels|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
Active Comparator: Grape seed
Grape seed extract
Dietary Supplement: Grape seed extract
Subjects will daily consume one capsule with grape seed extract for 8 weeks.
Other Name: Polyphenol
Placebo Comparator: Placebo
Dietary Supplement: Microcrystalline cellulose (placebo)
Subjects will daily consume one capsule with microcrystalline cellulose for 8 weeks.
- Difference between treatment and placebo in changes from baseline of ambulatory systolic and diastolic blood pressure [ Time Frame: 8 weeks of intervention ]
- Difference between treatment and placebo in changes from baseline of mechanistic markers in plasma and/or urine (vasoactive factors and markers of polyphenol metabolism) and platelet function (only measured in case of a relevant BP-lowering effect) [ Time Frame: 8 weeks of intervention ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00869193
|Unilever R&D Vlaardingen|
|Vlaardingen, Netherlands, 3133 AT|
|Principal Investigator:||Rouyanne T Ras, Msc||Unilever R&D Vlaardingen|