This trial is active, not recruiting.

Condition hypertension
Treatments grape seed extract, grape seed extract placebo
Sponsor Institute for Food Safety and Health, United States
Collaborator Polyphenolics, Inc.
Start date November 2009
End date October 2017
Trial size 72 participants
Trial identifier NCT00979732, GSE 2009-050


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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
(Active Comparator)
Grape seed extract capsule 150 mg/BID
grape seed extract
grape seed extract 150 mg twice a day (BID) in beverage or capsule form
(Placebo Comparator)
placebo grape seed extract capsule 150 mg/BID
grape seed extract placebo
grape seed extract 150 mg twice a day (BID) in beverage or capsule form
(Active Comparator)
grape seed extract beverage 150 mg/BID
grape seed extract
grape seed extract 150 mg twice a day (BID) in beverage or capsule form
(Placebo Comparator)
grape seed extract placebo beverage 150 mg/BID
grape seed extract placebo
grape seed extract 150 mg twice a day (BID) in beverage or capsule form

Primary Outcomes

Demonstrate the effectiveness of grape seed extract (GSE) in the lowering of systolic and diastolic blood pressure
time frame: 10 weeks

Secondary Outcomes

Changes in markers of inflammation, oxidation and endothelial function in plasma.
time frame: 10 weeks

Eligibility Criteria

Male or female participants from 25 years up to 65 years old.

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)

Additional Information

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.
Principal investigator Britt Burton-Freeman, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Institute for Food Safety and Health, United States.