Status:
COMPLETED
Effect of Grape Seed Extract on Blood Pressure
Lead Sponsor:
Unilever R&D
Collaborating Sponsors:
University of Edinburgh
Conditions:
Elevated Blood Pressure
Eligibility:
All Genders
35-75 years
Phase:
NA
Brief Summary
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 eleva...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00869193
Start Date
March 1 2009
End Date
July 1 2009
Last Update
August 28 2009
Active Locations (1)
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1
Unilever R&D Vlaardingen
Vlaardingen, Netherlands, 3133 AT