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

Hypertension Clinical Trial

— RGC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01146470
• Other study ID #: TASMC-10-NV-0176-CTIL
• Secondary ID: RGC
• Status: Completed
• Phase: N/A
• First received: June 16, 2010
• Last updated: February 17, 2013
• Start date: July 2010
• Est. completion date: January 2012

Study information

• Verified date: June 2010
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Dietary Supplement:
• RGC
dosage of Red Grape Cells once a day, during 3 months
• Placebo
dosage of Placebo once a day, during 3 months

Locations

Country	Name	City	State
Israel	Tel Aviv Medical Center	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center	Fruitura Bioscience Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate the influence of RGC on blood pressure and vascular function.		3 months of treatment	Yes
Secondary	The change in oxidative stress parameters		3 months of treatment	No