The Influence of Red Grape Cells on Blood Pressure Vascular Function in People With Hypertension

Study Overview
=================
Brief Summary
-----------------
The study hypothesis is that 3 Months Daily Supplementation of RGC will effect blood pressure and vascular function. This will be a single-center, double-blind, random, parallel controlled Study. Study population will include 60 subjects, who will be divided randomly into three groups. The first group will get RGC 200mg, the second group will get RGC 400mg, and the third group will get 200mg placebo.

Official Title
-----------------
A Single-Center, Double-blind, Random, Parallel Controlled Study

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Dietary Supplement: RGC
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 35-70 BMI < 40.0 kg/m2 Blood pressure: SYS. ≤154 mmHg, DIA. ≤93 mmHg. Exclusion Criteria: Breastfeeding or pregnancy. Milk allergy - the substance may contain traces of milk protein (casein). Taking anti-hypertensive medications. Taking antioxidant food supplements, excluding probiotic agents and fibers (taken for less than two weeks before beginning the study). Subjects suffering from any of the following conditions: cardiovascular disorders, renal disorders, intestinal disorders, hepatic disease, malignant or autoimmune diseases or other metabolic diseases. A subject whose baseline blood tests indicate abnormalities in hepatic or renal function, thyroid function or blood count. Unusual eating habits. The subject is in the process of active weight loss / gain. Addiction to drugs / alcohol. Medically documented psychiatric problems or neurological disorders. Smokers. (Subjects who quit smoking more than two years ago may be included in the study). Systolic blood pressure above 154 mmHg. Diastolic blood pressure above 93 mmHg. Taking phosphodiesterase 5 inhibitors for the treatment of erectile dysfunction (Viagra, Cialis, etc.).

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RGC 200 mg<br> | Dietary Supplement: RGC<br>* dosage of Red Grape Cells once a day, during 3 months<br>|
| Experimental: RGC 400 mg<br> | Dietary Supplement: RGC<br>* dosage of Red Grape Cells once a day, during 3 months<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* dosage of Placebo once a day, during 3 months<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the influence of RGC on blood pressure and vascular function. |  | 3 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in oxidative stress parameters |  | 3 months of treatment |