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

NCT ID: NCT00979732

Last Updated: 2021-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-15
• Study Completion Date: 2014-10-15

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).

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

GSE beverage active

grape seed extract beverage 150 mg/BID

Group Type: ACTIVE_COMPARATOR

grape seed extract

Intervention Type: DIETARY_SUPPLEMENT

grape seed extract 150 mg twice a day (BID) in beverage or capsule form

GSE beverage placebo

grape seed extract placebo beverage 150 mg/BID

Group Type: PLACEBO_COMPARATOR

grape seed extract placebo

Intervention Type: DIETARY_SUPPLEMENT

grape seed extract 150 mg twice a day (BID) in beverage or capsule form

Interventions

grape seed extract

grape seed extract 150 mg twice a day (BID) in beverage or capsule form

Intervention Type: DIETARY_SUPPLEMENT

grape seed extract placebo

grape seed extract 150 mg twice a day (BID) in beverage or capsule form

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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)

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Polyphenolics, Inc.

INDUSTRY

Sponsor Role: collaborator

Clinical Nutrition Research Center, Illinois Institute of Technology

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Britt Burton-Freeman, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Nutrition Research Center, Illinois Institute of Technology

Indika Edirisinghe, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Nutrition Research Center, Illinois Institute of Technology

Locations

Clinical Nutrition Research Center

Chicago, Illinois, United States

Countries

United States

References

Edirisinghe I, Burton-Freeman B, Tissa Kappagoda C. Mechanism of the endothelium-dependent relaxation evoked by a grape seed extract. Clin Sci (Lond). 2008 Feb;114(4):331-7. doi: 10.1042/CS20070264.

Reference Type: BACKGROUND

PMID: 17927567 (View on PubMed)

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.

Reference Type: BACKGROUND

Sivaprakasapillai B, Edirisinghe I, Randolph J, Steinberg F, Kappagoda T. Effect of grape seed extract on blood pressure in subjects with the metabolic syndrome. Metabolism. 2009 Dec;58(12):1743-6. doi: 10.1016/j.metabol.2009.05.030. Epub 2009 Jul 15.

Reference Type: BACKGROUND

PMID: 19608210 (View on PubMed)

Other Identifiers

GSE 2009-050

Identifier Type: -

Identifier Source: org_study_id