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

June 16, 2010
February 17, 2013
July 2010
January 2012   (final data collection date for primary outcome measure)
To investigate the influence of RGC on blood pressure and vascular function. [ Time Frame: 3 months of treatment ] [ Designated as safety issue: Yes ]
To investigate the influence of RGC on blood pressure and vascular function.
Complete list of historical versions of study NCT01146470 on ClinicalTrials.gov Archive Site
The change in oxidative stress parameters [ Time Frame: 3 months of treatment ] [ Designated as safety issue: No ]
The change in oxidative stress parameters
Not Provided
Not Provided
 
The Influence of Red Grape Cells on Blood Pressure Vascular Function in People With Hypertension
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypertension
  • Dietary Supplement: RGC
    dosage of Red Grape Cells once a day, during 3 months
  • Dietary Supplement: Placebo
    dosage of Placebo once a day, during 3 months
  • Experimental: RGC 200 mg
    Intervention: Dietary Supplement: RGC
  • Experimental: RGC 400 mg
    Intervention: Dietary Supplement: RGC
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
January 2012
January 2012   (final data collection date for primary outcome measure)

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.).
Both
35 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01146470
TASMC-10-NV-0176-CTIL, RGC
No
Tel-Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
Fruitura Bioscience Ltd.
Principal Investigator: Nachum Vaisman, Professor Tel-Aviv Sourasky Medical Center, Israel
Tel-Aviv Sourasky Medical Center
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP