Elevated Blood Pressure Clinical Trial
Official title:
Effect of Grape Seed Extract High in Polyphenols on Blood Pressure in Subjects With Elevated Blood Pressure Levels
The purpose of this study is to determine whether an 8-week intervention with grape seed extract is effective in reducing daytime ambulatory blood pressure in male and postmenopausal female with elevated daytime blood pressure values.
Status | Completed |
Enrollment | 70 |
Est. completion date | July 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 35 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Male and postmenopausal female subjects in the age = 35 and = 75 at start of the study - BMI = 18.5 and = 30.0 kg/m2 - Apparently healthy: no reported diseases that may affect study results and pre-selected blood parameters within normal range - Informed consent signed - Willing to refrain from supplements, food products, diets and drugs that may interfere with the outcomes of the study Exclusion Criteria: - Mean of 6-hour ambulatory SBP < 120 mmHg, > 159 mmHg and/or DBP > 99 mmHg - 10-year risk mortality risk on CVD > 10% according to NHG standard M84. For subjects > 65 years of age and SBP = 140 mmHg the study physician will assess eligibility - Irregular pulse or pulse < 50 or > 100 bpm - Intense exercise >10 h/w - Reported weight loss/gain > 10% of body weight in the 6 month preceding pre-study examination - The habit of smoking during the past year |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
Netherlands | Unilever R&D Vlaardingen | Vlaardingen |
Lead Sponsor | Collaborator |
---|---|
Unilever R&D | University of Edinburgh |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference between treatment and placebo in changes from baseline of ambulatory systolic and diastolic blood pressure | 8 weeks of intervention | No | |
Secondary | 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) | 8 weeks of intervention | No |
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