Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2009-03-31
2009-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TRIPLE
Study Groups
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Grape seed
Grape seed extract
Grape seed extract
Subjects will daily consume one capsule with grape seed extract for 8 weeks.
Placebo
Microcrystalline cellulose
Microcrystalline cellulose (placebo)
Subjects will daily consume one capsule with microcrystalline cellulose for 8 weeks.
Interventions
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Grape seed extract
Subjects will daily consume one capsule with grape seed extract for 8 weeks.
Microcrystalline cellulose (placebo)
Subjects will daily consume one capsule with microcrystalline cellulose for 8 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
35 Years
75 Years
ALL
No
Sponsors
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University of Edinburgh
OTHER
Unilever R&D
INDUSTRY
Responsible Party
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Unilever R&D Vlaardingen
Principal Investigators
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Rouyanne T Ras, Msc
Role: PRINCIPAL_INVESTIGATOR
Unilever R&D Vlaardingen
Locations
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Unilever R&D Vlaardingen
Vlaardingen, , Netherlands
Countries
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Other Identifiers
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08050V
Identifier Type: -
Identifier Source: org_study_id