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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: May 19, 2013
Last verified: May 2013
History of Changes
  Purpose

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).


Condition Intervention
Hypertension
 Dietary Supplement: grape seed extract
Dietary Supplement: grape seed extract placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institute for Food Safety and Health, United States:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Changes in markers of inflammation, oxidation and endothelial function in plasma. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: November 2009
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: GSE capsule active
Grape seed extract capsule 150 mg/BID
 Dietary Supplement: grape seed extract
grape seed extract 150 mg twice a day (BID) in beverage or capsule form
Placebo Comparator: GSE capsule placebo
placebo grape seed extract capsule 150 mg/BID
 Dietary Supplement: grape seed extract placebo
grape seed extract 150 mg twice a day (BID) in beverage or capsule form
Active Comparator: GSE beverage active
grape seed extract beverage 150 mg/BID
 Dietary Supplement: grape seed extract
grape seed extract 150 mg twice a day (BID) in beverage or capsule form
Placebo Comparator: GSE beverage placebo
grape seed extract placebo beverage 150 mg/BID
 Dietary Supplement: grape seed extract placebo
grape seed extract 150 mg twice a day (BID) in beverage or capsule form

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.
  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00979732

Locations
United States, Illinois
Clinical Nutrition Research Center
Chicago, Illinois, United States, 60616
Sponsors and Collaborators
Institute for Food Safety and Health, United States
Polyphenolics, Inc.
Investigators
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
  More Information

Publications:
Brahmesh S, Edirisinghe I, Randolph J, Steinberg F and Kappagoda T. Effect of a polyphenoics extracts of grape seeds (GSE) on blood pressure in patients with metabolic syndrome (MetS). FASEBJ. 2006;20:A305.

Responsible Party: Institute for Food Safety and Health, United States
ClinicalTrials.gov Identifier: NCT00979732     History of Changes
Other Study ID Numbers: GSE 2009-050
Study First Received: September 16, 2009
Last Updated: May 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Institute for Food Safety and Health, United States:
high blood pressure
dietary supplements
nutrition

Additional relevant MeSH terms:
Hypertension
Prehypertension
Vascular Diseases
Cardiovascular Diseases
Grape Seed Extract
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013