Hypertension
Conditions
Keywords
high blood pressure, dietary supplements, nutrition
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.
Interventions
DIETARY_SUPPLEMENTgrape seed extract
grape seed extract 150 mg twice a day (BID) in beverage or capsule form
DIETARY_SUPPLEMENTgrape seed extract placebo
grape seed extract 150 mg twice a day (BID) in beverage or capsule form
Sponsors
Polyphenolics, Inc.
Clinical Nutrition Research Center, Illinois Institute of Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure | 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
| Measure | Time frame | Description |
|---|---|---|
| Plasma Insulin Level Over 6 Weeks | 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. |
Countries
United States
Participant flow
Recruitment details
The study was performed at the Clinical Nutrition Research Center at the Illinois Institute of Technology (Chicago, IL, USA) from 2010 to 2014.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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 | 12 |
| 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 | 17 |
| Total | 29 |
Baseline characteristics
| Characteristic | Total | GSE Beverage Active | GSE Beverage Placebo |
|---|---|---|---|
| Age, Continuous | 43 years STANDARD_DEVIATION 10 | 44 years STANDARD_DEVIATION 10 | 42 years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 11 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 7 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 10 Participants | 4 Participants | 6 Participants |
| Region of Enrollment United States | 29 participants | 12 participants | 17 participants |
| Sex: Female, Male Female | 14 Participants | 6 Participants | 8 Participants |
| Sex: Female, Male Male | 15 Participants | 6 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 17 |
| other Total, other adverse events | 0 / 12 | 0 / 17 |
| serious Total, serious adverse events | 0 / 12 | 0 / 17 |
Outcome results
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.
Time frame: 6 weeks
Population: All completers
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GSE Beverage Active | Systolic Blood Pressure | 118 mmHg | Standard Error 2.3 |
| GSE Beverage Placebo | Systolic Blood Pressure | 127 mmHg | Standard Error 1.9 |
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.
Time frame: 6 weeks
Population: All completer
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GSE Beverage Active | Plasma Insulin Level Over 6 Weeks | 17.8 µIU/mL | Standard Error 1.5 |
| GSE Beverage Placebo | Plasma Insulin Level Over 6 Weeks | 20.9 µIU/mL | Standard Error 1.2 |