- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00551746
The Purple Grape Juice Study
Anti-thrombotic Effects of Long Term Consumption of Purple Grape Juice in Healthy People
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study treatment period will be 90 days (13 weeks, or 3 months) and the treatment dose will be 7 mL/kg/day. The treatment dose is a standard dose previously worked out in other research and was used in a variety of other clinical research (27, 32). Study randomization will be performed in a double-blind fashion with study investigators and participants unaware of group assignment. Randomization order will be created using a randomized blocked design. After volunteer consent is provided, the clinical study coordinator will open a sequentially-numbered envelope containing the study group assignment and provide a 4 week supply of study beverage.
Participants will be seen for follow-up study visits at approximately 4 week intervals after the baseline enrollment visit. Compliance with study treatment (PGJ or placebo) will be assessed by interview at visits 2, 3, and 4. At the conclusion of visits 2 and 3, a supply of study beverage will be provided to the participant for consumption during the ensuing 4 weeks. Study beverage supplies remaining at the end of the 90-day study period will be donated to each participant.
Platelet Aggregation testing will be performed by ThromboVision (Salt Lake City, UT) using multiple platelet agonists, including ADP, collagen/epinephrine, PMA, and TRAP. Each of these aggregation inducers target a separate platelet activation pathway.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Utah
-
Murray, Utah, United States, 84157
- Intermountain Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The volunteer (male or non-pregnant female, any ethnicity) must be > 18 years of age.
- The volunteer has no history of a physician diagnosis of atherosclerosis such as carotid, peripheral, or coronary artery disease (CAD).
- The volunteer has no history of a physician diagnosis of pulmonary embolism (PE), MI, or stroke.
- The volunteer must sign a written informed consent, prior to the procedure, using a form that is approved by the local Institutional Review Board.
Exclusion Criteria:
- A diagnosis if diabetes mellitus.
- The limitations for specific medications, supplements and food items are exceeded as follows:
More than 1 normal dose of the following medications and/or supplements once a week during the 3 months prior to enrollment:
- aspirin • ibuprofen • fish-oil extracts
- antioxidants • vitamins
More than 1 normal serving per week in the 3 months prior to enrollment:
- other grape juices • tea • wine
- beer • alcoholic drinks • grapes
More than 5 servings per day in any combination in the 7 days (1 weeks prior to enrollment:
- non-grape juices • garlic • broccoli
- apples • any type of berries • onions Volunteer is pregnant or lactating at the time of enrollment.
Secondary Exclusions:
- Use of any of the above listed items during the 12 week course of study treatment will be documented and excess use 3 times or more will result in an administrative withdrawal of the volunteer from the study prior to the measurement of the next monthly platelet aggregation laboratory values (although those values will be measured for exploratory evaluation and the participant will remain under treatment until the end of the 12 week period).
- Routine consumption of fruit juices, or of >5 servings per day of referenced fruits or vegetables, will result in administrative withdrawal of the participant from the study's primary aim.
- Although it is unlikely the use of PGJ or look alike/ taste alike (placebo) beverage will harm the pregnant or lactating woman, the dietary restrictions placed on the participant for the duration of the study may conflict with dietary recommendations for pregnant or lactating women. Women of child bearing potential, therefore, will meet a secondary exclusion if they become pregnant.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Grape Juice
|
Grape Juice
|
Placebo Comparator: 2
Grape Juice Placebo
|
Grape Juice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare Change in Platelet Aggregation as Measured by Adenosine Diphosphate (ADP) Between PGJ and Placebo
Time Frame: 90-days
|
Platelet aggregation was measured using the agonist ADP (10 microM) in a light transmission aggregometer and compared between PGJ and placebo via the intent-to-treat paradigm.
|
90-days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare Platelet Inhibitory Pathways of ADP,TRAP, PMA, Arachadonic Acid Between PGJ and Placebo.
Time Frame: 90-days
|
The platelet inhibitory pathway in which PGJ functions by performing platelet aggregation tests using agonists for the 4 major platelet activation pathways: ADP,thrombin receptor-activator peptide (TRAP), phorbol 12-myristate 13-acetate (PMA), arachadonic acid(10 microM) in a light transmission aggregometer and compared between PGJ and placebo via the intent-to-treat paradigm.
|
90-days
|
The Impact of Polymorphism in Haemostatic Genes on Variation in Platelet Function Among Participants Based on Long-term PGJ Consumption.
Time Frame: 90-days
|
90-days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Benjamin D Horne, PhD, MPH, Intermountain Medical Center, Murray, UT
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 128-126
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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