Trial | NCT01146470  Report issue

Title

The Influence of Red Grape Cells on Blood Pressure Vascular Function in People With Hypertension
A Single-Center, Double-blind, Random, Parallel Controlled Study

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    50
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.
Study Started
Jul 31
2010
Primary Completion
Jan 31
2012
Study Completion
Jan 31
2012
Last Update
Feb 20
2013
Estimate

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

RGC 200 mg Experimental

  • Dietary Supplement RGC

RGC 400 mg Experimental

  • Dietary Supplement RGC

Placebo Placebo Comparator

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.).
No Results Posted