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

This study has been completed.
Sponsor:
Collaborator:
Fruitura Bioscience Ltd.
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01146470
First received: June 16, 2010
Last updated: February 17, 2013
Last verified: June 2010
History of Changes
  Purpose

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.


Condition Intervention
Hypertension
 Dietary Supplement: RGC
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Single-Center, Double-blind, Random, Parallel Controlled Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • To investigate the influence of RGC on blood pressure and vascular function. [ Time Frame: 3 months of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The change in oxidative stress parameters [ Time Frame: 3 months of treatment ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: July 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: Placebo Dietary Supplement: Placebo
dosage of Placebo once a day, during 3 months

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01146470

Locations
Israel
Tel Aviv Medical Center
Tel Aviv, Israel
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Fruitura Bioscience Ltd.
Investigators
Principal Investigator: Nachum Vaisman, Professor Tel-Aviv Sourasky Medical Center, Israel
  More Information

No publications provided

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01146470     History of Changes
Other Study ID Numbers: TASMC-10-NV-0176-CTIL, RGC
Study First Received: June 16, 2010
Last Updated: February 17, 2013
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013