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| Name | Class |
|---|---|
| Polyphenolics, Inc. | INDUSTRY |
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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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSE beverage active | Active Comparator | grape seed extract beverage 150 mg/BID |
|
| GSE beverage placebo | Placebo Comparator | grape seed extract placebo beverage 150 mg/BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| grape seed extract | Dietary Supplement | grape seed extract 150 mg twice a day (BID) in beverage or capsule form |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Insulin Level Over 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. | 6 weeks |
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Inclusion Criteria:
male and female
pre-hypertensive
no clinical evidence of cardiovascular, respiratory, renal, gastrointestinal or hepatic disease
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Nutrition Research Center | Chicago | Illinois | 60616 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17927567 | Background | 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. | |
| 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. | ||
| 19608210 |
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Eligible subjects started with a 2-week run-in period drinking the Placebo beverage twice per day. After the 2-week run-in period, subjects were randomised to one of the two groups (Placebo or GSE beverage), equally allocated to each treatment (1:1 randomisation ratio).
The study was performed at the Clinical Nutrition Research Center at the Illinois Institute of Technology (Chicago, IL, USA) from 2010 to 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | GSE Beverage Active | grape seed extract beverage 150 mg/BID grape seed extract: grape seed extract 150 mg twice a day (BID) in beverage or capsule form |
| FG001 | GSE Beverage Placebo | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline data were collected at the screening
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| ID | Title | Description |
|---|---|---|
| BG000 | GSE Beverage Active | grape seed extract beverage 150 mg/BID grape seed extract: grape seed extract 150 mg twice a day (BID) in beverage or capsule form |
| BG001 | GSE Beverage Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All completers | Posted | Mean | Standard Error | mmHg | 6 weeks |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GSE Beverage Active | grape seed extract beverage 150 mg/BID grape seed extract: grape seed extract 150 mg twice a day (BID) in beverage or capsule form |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Britt Burton-Freeman | Illinois Institute of Techology | 708-341-0178 | bburton@iit.edu |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D056604 | Grape Seed Extract |
| ID | Term |
|---|---|
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| grape seed extract placebo | Dietary Supplement | grape seed extract 150 mg twice a day (BID) in beverage or capsule form |
|
| 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. |
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
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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
|
|
| Secondary | Plasma Insulin Level Over 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. | All completer | Posted | Mean | Standard Error | µIU/mL | 6 weeks |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | GSE Beverage Placebo | 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 | 0 | 17 | 0 | 17 | 0 | 17 |
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| D004364 |
| Pharmaceutical Preparations |