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Completed

NCT Number: NCT01146470

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tel Aviv Medical Center

Tel Aviv, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

RGC

Dietary Supplement

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

Placebo

Dietary Supplement

dosage of Placebo once a day, during 3 months

Primary outcomes

  1. To investigate the influence of RGC on blood pressure and vascular function.

    Time frame: 3 months of treatment

Secondary outcomes

  1. The change in oxidative stress parameters

    Time frame: 3 months of treatment

Sponsors and collaborators

Lead sponsor

Tel-Aviv Sourasky Medical Center

Other Gov

Collaborators

  • Fruitura Bioscience Ltd.

Registry information

Official study title

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

Acronym: RGC

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 17, 2010
Registry last updated
Feb 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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