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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00979732
Recruitment Status : Completed
First Posted : September 18, 2009
Results First Posted : February 11, 2021
Last Update Posted : February 11, 2021
Sponsor:
Collaborator:
Polyphenolics, Inc.
Information provided by (Responsible Party):
Clinical Nutrition Research Center, Illinois Institute of Technology

Study Description
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Brief 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).


Condition or disease Intervention/treatment Phase
Hypertension Dietary Supplement: grape seed extract Dietary Supplement: grape seed extract placebo Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Actual Study Start Date : November 15, 2009
Actual Primary Completion Date : October 15, 2014
Actual Study Completion Date : October 15, 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Systolic Blood Pressure [ Time Frame: 6 weeks ]
    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.


Secondary Outcome Measures :
  1. Plasma Insulin Level Over 6 Weeks [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00979732


Locations
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United States, Illinois
Clinical Nutrition Research Center
Chicago, Illinois, United States, 60616
Sponsors and Collaborators
Clinical Nutrition Research Center, Illinois Institute of Technology
Polyphenolics, Inc.
Investigators
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Principal Investigator: Britt Burton-Freeman, PhD Clinical Nutrition Research Center, Illinois Institute of Technology
Principal Investigator: Indika Edirisinghe, PhD Clinical Nutrition Research Center, Illinois Institute of Technology
More Information
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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.

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Responsible Party: Clinical Nutrition Research Center, Illinois Institute of Technology
ClinicalTrials.gov Identifier: NCT00979732    
Other Study ID Numbers: GSE 2009-050
First Posted: September 18, 2009    Key Record Dates
Results First Posted: February 11, 2021
Last Update Posted: February 11, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Clinical Nutrition Research Center, Illinois Institute of Technology:
high blood pressure
dietary supplements
nutrition
Additional relevant MeSH terms:
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Grape Seed Extract
Hypertension
Prehypertension
Vascular Diseases
Cardiovascular Diseases
Antineoplastic Agents, Phytogenic
 Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs