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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Dietary supplement: RGC; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel
    • Tel Aviv Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; dosage of Placebo once a day, during 3 months
Experimental: RGC 200 mg	Dietary supplement: RGC; dosage of Red Grape Cells once a day, during 3 months
Experimental: RGC 400 mg	Dietary supplement: RGC; dosage of Red Grape Cells once a day, during 3 months

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Collaborators: Fruitura Bioscience Ltd.
• Investigators: Principal Investigator: Nachum Vaisman, Professor, Tel-Aviv Sourasky Medical Center, Israel

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: June 16, 2010
• First Submitted That Met QC Criteria: June 16, 2010
• First Posted (Estimate): June 17, 2010

Study Record Updates

• Last Update Posted (Estimate): February 20, 2013
• Last Update Submitted That Met QC Criteria: February 17, 2013
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: TASMC-10-NV-0176-CTIL; RGC