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

NCT00979732 | Completed Results

• 1 other identifier: GSE 2009-050
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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).

Conditions

Hypertension

Keywords

high blood pressure; dietary supplements; nutrition

Outcome Measures

Primary Outcomes (1)

• Systolic Blood Pressure

  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.

  6 weeks

Secondary Outcomes (1)

• Plasma Insulin Level Over 6 Weeks

  6 weeks

Study Arms (2)

GSE beverage active

ACTIVE COMPARATOR

grape seed extract beverage 150 mg/BID

Dietary Supplement: grape seed extract

GSE beverage placebo

PLACEBO COMPARATOR

grape seed extract placebo beverage 150 mg/BID

Dietary Supplement: grape seed extract placebo

Interventions

grape seed extract DIETARY_SUPPLEMENT

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

GSE beverage active

grape seed extract placebo DIETARY_SUPPLEMENT

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

GSE beverage placebo

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Clinical Nutrition Research Center, Illinois Institute of Technology: lead
• Polyphenolics, Inc.: collaborator

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

Related Publications (3)

• 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.

  PMID: 17927567 BACKGROUND

• 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.

  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.

  PMID: 19608210 BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

Grape Seed Extract

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures; Pharmaceutical Preparations

Limitations and Caveats

The study was not sufficiently powered to detect significant differences on the secondary end points. We observed large inter-individual variability in plasma phenolic concentrations, requiring a greater sample size.

Results Point of Contact

• Title: Britt Burton-Freeman
• Organization: Illinois Institute of Techology

bburton@iit.edu

708-341-0178

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2009
• First Posted: September 18, 2009
• Study Start: November 15, 2009
• Primary Completion: October 15, 2014
• Study Completion: October 15, 2014
• Last Updated: February 11, 2021
• Results First Posted: February 11, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)