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

Tel Aviv Sourasky Medical Center

Status: Completed

Conditions: Hypertension

Treatments: Dietary Supplement: Placebo; Dietary Supplement: RGC

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01146470

TASMC-10-NV-0176-CTIL

RGC

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

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.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 3 patient groups, including a placebo group

RGC 200 mg

Experimental group

Treatment:

Dietary Supplement: RGC

RGC 400 mg

Experimental group

Treatment:

Dietary Supplement: RGC

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo