NCT00869193

Effect of Grape Seed Extract on Blood Pressure

Effect of Grape Seed Extract High in Polyphenols on Blood Pressure in Subjects With Elevated Blood Pressure Levels

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Unilever R&D · Industry
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

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 elevated daytime blood pressure values.

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 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.

Conditions

• Elevated Blood Pressure

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Grape seed extract	Subjects will daily consume one capsule with grape seed extract for 8 weeks.
DIETARY_SUPPLEMENT	Microcrystalline cellulose (placebo)	Subjects will daily consume one capsule with microcrystalline cellulose for 8 weeks.

Timeline

• Start date: 2009-03-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2009-03-25
• Last updated: 2009-08-28

Locations

1 site across 1 country: Netherlands