The Influence of Red Grape Cells on Blood Pressure Vascular Function in People With Hypertension
RGC
A Single-Center, Double-blind, Random, Parallel Controlled Study
2 other identifiers
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hypertension
Started Jul 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2010
CompletedFirst Posted
Study publicly available on registry
June 17, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedFebruary 20, 2013
June 1, 2010
1.5 years
June 16, 2010
February 17, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
To investigate the influence of RGC on blood pressure and vascular function.
3 months of treatment
Secondary Outcomes (1)
The change in oxidative stress parameters
3 months of treatment
Study Arms (3)
RGC 200 mg
EXPERIMENTALRGC 400 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Age 35-70
- BMI \< 40.0 kg/m2
- Blood pressure: SYS. ≤154 mmHg, DIA. ≤93 mmHg.
You may not qualify if:
- 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.).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tel-Aviv Sourasky Medical Centerlead
- Fruitura Bioscience Ltd.collaborator
Study Sites (1)
Tel Aviv Medical Center
Tel Aviv, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nachum Vaisman, Professor
Tel-Aviv Sourasky Medical Center, Israel
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2010
First Posted
June 17, 2010
Study Start
July 1, 2010
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
February 20, 2013
Record last verified: 2010-06