The Influence of Red Grape Cells on Blood Pressure Vascul... | NCT01146470

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

NCT01146470

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Completed

Last Update Posted

Feb 20, 2013Estimated

Enrollment

50Actual

Phase

Not Applicable

Conditions

Hypertension

Interventions

RGC
Placebo

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
RGC

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Jan 2012Actual

Completion Date

Jan 2012Actual

First Submitted Date

Jun 16, 2010

First Submission Date that Met QC Criteria

Jun 16, 2010

First Posted Date

Jun 17, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2013

Last Update Posted Date

Feb 20, 2013Estimated

Name	Class
Fruitura Bioscience Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
RGC 200 mg	Experimental	Dietary Supplement: RGC
RGC 400 mg	Experimental	Dietary Supplement: RGC
Placebo	Placebo Comparator	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RGC	Dietary Supplement	dosage of Red Grape Cells once a day, during 3 months	RGC 200 mg RGC 400 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To investigate the influence of RGC on blood pressure and vascular function.		3 months of treatment

Secondary Outcomes

Measure	Description	Time Frame
The change in oxidative stress parameters		3 months of treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases