The Effect of Grape Seed Extract on Blood Pressure in People With Pre-Hypertension

Study Overview
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Brief Summary
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In this research study, the investigators are interested in learning how extracts from grape seeds can help those individuals with high blood pressure. The investigators also hope to learn how grape seed extract effects your blood and cell functions. The grape seed extract the investigators will use in the study will be provided either in a beverage or a capsule form and is currently available on the market. This study is also using a placebo; therefore the treatment subjects receive may or may not contain the grape seed extract. The purpose of this study is to determine if the grape seed extract (GSE) will lower blood pressure in people with slightly high blood pressure (Pre-Hypertension).

Detailed Description
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Elevated blood pressure, or hypertension, is a major risk factor for heart disease and stroke. Systolic and diastolic blood pressures meeting criteria for pre-hypertension double the absolute risk of stroke and ischemic heart disease over an extended age range from the 4th to the 8th decade of life. Lifestyle, particularly the diet, is critical in the prevention and management of hypertension. Polyphenolic compounds from various plant foods can promote blood pressure regulation and vascular health through protection of the endothelium from oxidant and or inflammatory stress and or stimulation of smooth muscle relaxation. We will use a purified grape seed extract (GSE) in the proposed trial. This extract has been granted Generally Recognized as Safe (GRAS) status by Food and drug administration (GRAS Notice # GRN 000125, dated 08/18/2003, FDA, USA). Furthermore, GSE for use in the present trial has been used in previous human clinical trails and shown potent vasodilator properties in vitro and blood pressure lowering in metabolic syndrome patients. The proposed trial aims to verify the blood pressure lowering effect of GSE in an 'at risk' population for hypertension and to explore the extent to which other pathways of chronic disease may be modulated by GSE consumption. Given this, the objectives of this study are as follows: The primary objective of the proposed study is to demonstrate the effectiveness of GSE to lower blood pressure in pre-hypertensive individuals. Secondary objectives will investigate the role of GSE to improve inflammatory- and oxidative stress- status, as well as its effect on endothelium function.

Official Title
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Randomized, Double-blind, Placebo-controlled Trial to Investigate the Effect of Grape Seed Extract Delivered in a Beverage on Blood Pressure in Individuals With Pre-hypertension.

Conditions
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Hypertension

Intervention / Treatment
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* Dietary Supplement: grape seed extract
* Dietary Supplement: grape seed extract placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male and female pre-hypertensive systolic blood pressure (mmHg) 120 - 139 or diastolic blood pressure (mmHg) 80 -89 no clinical evidence of cardiovascular, respiratory, renal, gastrointestinal or hepatic disease Exclusion Criteria: pregnant and or lactating taking over the counter antioxidant supplements taking prescription medications that may interfere with study procedures or endpoints unusual dietary habits actively trying to lose or gain weight addicted to drugs and/or alcohol medically documented psychiatric or neurological disturbances smoker (past smoker may be allowed if cessation is > 2 years)

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GSE beverage active<br>grape seed extract beverage 150 mg/BID | Dietary Supplement: grape seed extract<br>* grape seed extract 150 mg twice a day (BID) in beverage or capsule form<br>|
| Placebo Comparator: GSE beverage placebo<br>grape seed extract placebo beverage 150 mg/BID | Dietary Supplement: grape seed extract placebo<br>* grape seed extract 150 mg twice a day (BID) in beverage or capsule form<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Blood Pressure | BP was monitored using ambulatory BP monitors (Ambulo2400; Tiba Medical, Inc.) that were programmed to take BP measurements automatically at 1-h intervals for a period of 24 h. BP measurements were scheduled at week 0 and 6 of the intervention (for efficacy assessment). Day-time BP and night-time BP were divided based on the subject's sleeping hours and hours awake. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Insulin Level Over 6 Weeks | After 10-12 h of overnight fasting, fasting blood samples were collected at week 0 (baseline) and week 3 and 6 of the intervention. plasma insulin were evaluated. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high blood pressure, dietary supplements, nutrition