HypertensionRGCNCT01146470
The Influence of Red Grape Cells on Blood Pressure Vascular Function in People With Hypertension
A study testing RGC in people with Hypertension, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- RGC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2010to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 35-70
- BMI < 40.0 kg/m2
- Blood pressure: SYS. ≤154 mmHg, DIA. ≤93 mmHg.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Double-blind, Random, Parallel Controlled Study
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
- Being tested
- RGC, Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RGCDietary supplement
dosage of Red Grape Cells once a day, during 3 months
PlaceboDietary supplement
dosage of Placebo once a day, during 3 months
| Study group | Role | What they receive |
|---|---|---|
| RGC 200 mg | Experimental | Not described Receives: Dietary Supplement: RGC |
| RGC 400 mg | Experimental | Not described Receives: Dietary Supplement: RGC |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the influence of RGC on blood pressure and vascular function.
Measured: 3 months of treatment
Secondary outcomes (1)
The change in oxidative stress parameters
Measured: 3 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Fruitura Bioscience Ltd.
- Responsible party
- Sponsor
- Investigators
- Nachum Vaisman, Professor, Principal investigator, Tel-Aviv Sourasky Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146470
- Sponsor's protocol ID
- TASMC-10-NV-0176-CTIL
- Other IDs
- RGC
- Acronym
- RGC
- Status last verified
- Jun 2010
- First submitted
- 16 Jun 2010
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Double-blind, Random, Parallel Controlled Study
- ClinicalTrials.gov ID
- NCT01146470
- Acronym / sponsor ID
- RGC / TASMC-10-NV-0176-CTIL
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Fruitura Bioscience Ltd.
- Study start
- Jul 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 17 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RGC 200 mg | Experimental | Dietary Supplement: RGC |
| RGC 400 mg | Experimental | Dietary Supplement: RGC |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 35-70
- BMI < 40.0 kg/m2
- Blood pressure: SYS. ≤154 mmHg, DIA. ≤93 mmHg.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RGCdosage of Red Grape Cells once a day, during 3 months | Dietary supplement | RGC 200 mg, RGC 400 mg |
| Placebodosage of Placebo once a day, during 3 months | Dietary supplement | Placebo |
Primary outcome
To investigate the influence of RGC on blood pressure and vascular function.
Time frame: 3 months of treatment
1 secondary outcome
The change in oxidative stress parameters
Time frame: 3 months of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nachum Vaisman, Professor principal investigator
Tel-Aviv Sourasky Medical Center, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RGC in people with Hypertension, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the influence of RGC on blood pressure and vascular function. (time frame: 3 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2013.