Cardiovascular DiseaseNCT00551746
The Purple Grape Juice Study
A study testing Purple Grape Juice in people with Cardiovascular Disease, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial summary
Coronary heart disease (CHD) is the largest contributor to morbidity and mortality in the Western world and is associated with high-calorie diet, high body mass, and a variety of other factors. CHD can lead to myocardial infarction (MI) and other embolic events. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Purple Grape Juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Dec 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anti-thrombotic Effects of Long Term Consumption of Purple Grape Juice in Healthy People
Coronary heart disease (CHD) is the largest contributor to morbidity and mortality in the Western world and is associated with high-calorie diet, high body mass, and a variety of other factors. CHD can lead to myocardial infarction (MI) and other embolic events. In some areas such as France, though, a paradox of high-cholesterol diets but low CHD and MI incidence have been found. This paradox has been traced to the consumption of red wine. Further research suggests that components of the grapes used in red wine may be the source of the cardio-protective factors that have resulted in the French paradox. These components are also present in purple grape juice (PGJ). PGJ has been shown to have a variety of potential cardio-protective effects, including inhibition of platelet aggregation. Since PGJ does not contain alcohol it may provide an additional benefit by avoiding the physical and social implications of alcohol abuse. Since most of the research of PGJ has been in vitro, though, and the few studies in vivo have been in cross-over studies and over very short durations of 7 to 14 days, additional research is required to determine whether the long-term consumption of PGJ is of additional and sustained benefit, similar to long-term use of red wine in France. The proposed study is a 2 arm randomized, controlled (double-blind) study of PGJ and a calorically-matching placebo drink in 100 healthy individuals.
Read the 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.
- Conditions
- Cardiovascular Disease
- Being tested
- Purple Grape Juice
- Keywords
- purple grape juice, antioxidants, platelet aggregation, anti-thrombotic
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Purple Grape JuiceDietary supplement
Grape Juice
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Grape Juice Receives: Dietary Supplement: Purple Grape Juice |
| 2 | Placebo comparator | Grape Juice Placebo Receives: Dietary Supplement: Purple Grape Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare Change in Platelet Aggregation as Measured by Adenosine Diphosphate (ADP) Between PGJ and Placebo
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.
Measured: 90-days
Secondary outcomes (2)
Compare Platelet Inhibitory Pathways of ADP,TRAP, PMA, Arachadonic Acid Between PGJ and Placebo.
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.
Measured: 90-days
The Impact of Polymorphism in Haemostatic Genes on Variation in Platelet Function Among Participants Based on Long-term PGJ Consumption.
Measured: 90-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2007 (estimated)
- Study startJul 2007
- Primary completionSep 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Deseret Foundation, Welch's, Inc., ThromboVision, Inc.
- Investigators
- Benjamin D Horne, PhD, MPH, Principal investigator, Intermountain Medical Center, Murray, UT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00551746
- Sponsor's protocol ID
- 128-126
- Status last verified
- Sep 2011
- First submitted
- 29 Oct 2007
- Last updated
- 16 Sep 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-thrombotic Effects of Long Term Consumption of Purple Grape Juice in Healthy People
- ClinicalTrials.gov ID
- NCT00551746
- Acronym / sponsor ID
- 128-126
- Conditions
- Cardiovascular Disease
- Keywords
- purple grape juice, antioxidants, platelet aggregation, anti-thrombotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- Deseret Foundation, Welch's, Inc., ThromboVision, Inc.
- Study start
- Jul 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 31 Oct 2007 (estimated)
- Results
- Posted 7 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Coronary heart disease (CHD) is the largest contributor to morbidity and mortality in the Western world and is associated with high-calorie diet, high body mass, and a variety of other factors. CHD can lead to myocardial infarction (MI) and other embolic events. In some areas such as France, though, a paradox of high-cholesterol diets but low CHD and MI incidence have been found. This paradox has been traced to the consumption of red wine. Further research suggests that components of the grapes used in red wine may be the source of the cardio-protective factors that have resulted in the French paradox. These components are also present in purple grape juice (PGJ). PGJ has been shown to have a variety of potential cardio-protective effects, including inhibition of platelet aggregation. Since PGJ does not contain alcohol it may provide an additional benefit by avoiding the physical and social implications of alcohol abuse. Since most of the research of PGJ has been in vitro, though, and the few studies in vivo have been in cross-over studies and over very short durations of 7 to 14 days, additional research is required to determine whether the long-term consumption of PGJ is of additional and sustained benefit, similar to long-term use of red wine in France. The proposed study is a 2 arm randomized, controlled (double-blind) study of PGJ and a calorically-matching placebo drink in 100 healthy individuals.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: Purple Grape JuiceGrape Juice |
| 2 | Placebo comparator | Dietary Supplement: Purple Grape JuiceGrape Juice Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| Purple Grape JuiceGrape Juice | Dietary supplement | 1, 2 |
Primary outcome
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.
2 secondary outcomes
Compare Platelet Inhibitory Pathways of ADP,TRAP, PMA, Arachadonic Acid Between PGJ and Placebo.
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Benjamin D Horne, PhD, MPH principal investigator
Intermountain Medical Center, Murray, UT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Purple Grape Juice in people with Cardiovascular Disease, run by Intermountain Health Care, Inc. at 1 site in United States.
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 4 inclusion and 15 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 16 Sep 2011. 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 United States. 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?
Yes. Results are posted in the registry (first posted 7 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Compare Change in Platelet Aggregation as Measured by Adenosine Diphosphate (ADP) Between PGJ and Placebo (time frame: 90-days). 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 16 Sep 2011.