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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Polyphenolics, Inc.
Information provided by (Responsible Party):
Institute for Food Safety and Health, United States
ClinicalTrials.gov Identifier:
NCT00979732
First received: September 16, 2009
Last updated: November 21, 2013
Last verified: November 2013

September 16, 2009
November 21, 2013
November 2009
March 2014   (final data collection date for primary outcome measure)
Demonstrate the effectiveness of grape seed extract (GSE) in the lowering of systolic and diastolic blood pressure [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00979732 on ClinicalTrials.gov Archive Site
Changes in markers of inflammation, oxidation and endothelial function in plasma. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effect of Grape Seed Extract on Blood Pressure in People With Pre-Hypertension
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.

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).

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypertension
  • Dietary Supplement: grape seed extract
    grape seed extract 150 mg twice a day (BID) in beverage or capsule form
  • Dietary Supplement: grape seed extract placebo
    grape seed extract 150 mg twice a day (BID) in beverage or capsule form
  • Active Comparator: GSE capsule active
    Grape seed extract capsule 150 mg/BID
    Intervention: Dietary Supplement: grape seed extract
  • Placebo Comparator: GSE capsule placebo
    placebo grape seed extract capsule 150 mg/BID
    Intervention: Dietary Supplement: grape seed extract placebo
  • Active Comparator: GSE beverage active
    grape seed extract beverage 150 mg/BID
    Intervention: Dietary Supplement: grape seed extract
  • Placebo Comparator: GSE beverage placebo
    grape seed extract placebo beverage 150 mg/BID
    Intervention: Dietary Supplement: grape seed extract placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
72
March 2014
March 2014   (final data collection date for primary outcome measure)

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)
Both
25 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00979732
GSE 2009-050
No
Institute for Food Safety and Health, United States
Institute for Food Safety and Health, United States
Polyphenolics, Inc.
Principal Investigator: Britt Burton-Freeman, PhD Institute for Food Safety and Health, United States
Principal Investigator: Indika Edirisinghe, PhD Institute for Food Safety and Health, United States
Institute for Food Safety and Health, United States
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP