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

NCT ID: NCT01146470

Last Updated: 2013-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2012-01-31

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

RGC 200 mg

Group Type: EXPERIMENTAL

RGC

Intervention Type: DIETARY_SUPPLEMENT

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

RGC 400 mg

Group Type: EXPERIMENTAL

RGC

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

dosage of Placebo once a day, during 3 months

Interventions

RGC

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

dosage of Placebo once a day, during 3 months

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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.).

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fruitura Bioscience Ltd.

INDUSTRY

Sponsor Role: collaborator

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nachum Vaisman, Professor

Role: PRINCIPAL_INVESTIGATOR

Tel-Aviv Sourasky Medical Center, Israel

Locations

Tel Aviv Medical Center

Tel Aviv, , Israel

Countries

Israel

Other Identifiers

RGC

Identifier Type: -

Identifier Source: secondary_id

TASMC-10-NV-0176-CTIL

Identifier Type: -

Identifier Source: org_study_id