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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01146470
Acronym
RGC
Enrollment
50
Registered
2010-06-17
Start date
2010-07-31
Completion date
2012-01-31
Last updated
2013-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

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.

Interventions

DIETARY_SUPPLEMENTRGC

dosage of Red Grape Cells once a day, during 3 months

DIETARY_SUPPLEMENTPlacebo

dosage of Placebo once a day, during 3 months

Sponsors

Fruitura Bioscience Ltd.
CollaboratorINDUSTRY
Tel-Aviv Sourasky Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No

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.).

Design outcomes

Primary

MeasureTime frame
To investigate the influence of RGC on blood pressure and vascular function.3 months of treatment

Secondary

MeasureTime frame
The change in oxidative stress parameters3 months of treatment

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026