The Effect of Grape Seed Extract on Blood Pressure in People With Pre-Hypertension
Condition: Hypertension
MeSH terms: Hypertension; Prehypertension
Study type: Interventional

Summary: 
      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: 
      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:

        1. The primary objective of the proposed study is to demonstrate the effectiveness of GSE
           to lower blood pressure in pre-hypertensive individuals.

        2. Secondary objectives will investigate the role of GSE to improve inflammatory- and
           oxidative stress- status, as well as its effect on endothelium function.
    

Intervention name(s): grape seed extract; grape seed extract placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): grape seed extract 150 mg twice a day (BID) in beverage or capsule form; grape seed extract 150 mg twice a day (BID) in beverage or capsule form
Intervention MeSH terms: Grape Seed Extract
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: high blood pressure; dietary supplements; nutrition