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

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ClinicalTrials.gov Identifier: NCT01146470
Recruitment Status : Completed
First Posted : June 17, 2010
Last Update Posted : February 20, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Hypertension Dietary Supplement: RGC Dietary Supplement: Placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Single-Center, Double-blind, Random, Parallel Controlled Study
Study Start Date : July 2010
Primary Completion Date : January 2012
Study Completion Date : January 2012
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. To investigate the influence of RGC on blood pressure and vascular function. [ Time Frame: 3 months of treatment ]

Secondary Outcome Measures :
  1. The change in oxidative stress parameters [ Time Frame: 3 months of treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01146470     History of Changes
Other Study ID Numbers: TASMC-10-NV-0176-CTIL
RGC
First Posted: June 17, 2010    Key Record Dates
Last Update Posted: February 20, 2013
Last Verified: June 2010

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases