CompletedNCT00551746Updated Sep 16, 2011Results posted

The Purple Grape Juice Study

An interventional study of Purple Grape Juice in Cardiovascular Disease, sponsored by Intermountain Health Care, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-09-16.

Sponsored by Intermountain Health Care, Inc. · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 70
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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. 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 studied

Cardiovascular Disease

Browse trials for

Cardiovascular Diseases 4,904

Keywords

purple grape juice
antioxidants
platelet aggregation
anti-thrombotic

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 70 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Intermountain Health Care, Inc. is the lead sponsor of 118 studies on the registry; 15 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 3 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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 design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single group
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 70 participants (actual)

Study arms

Active comparator
1
Grape Juice
Dietary Supplement: Purple Grape Juice
Placebo comparator
2
Grape Juice Placebo
Dietary Supplement: Purple Grape Juice

Interventions

Dietary supplementPurple Grape Juice
Grape Juice

What researchers measure

Primary outcomes

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.
Time frame: 90-days

Secondary outcomes

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.
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

Posted Sep 7, 2011

Participant flow

Recruitment period: August, 2007 to June, 2009

Participant flow — Overall Study
Milestone	Grape Juice	Grape Juice Placebo
Started	36	34
Completed	25	26
Not completed	11	8

Outcome measures

PrimaryCompare 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.

Time frame:: 90-days
Reported as:: Mean · percent

Compare Change in Platelet Aggregation as Measured by Adenosine Diphosphate (ADP) Between PGJ and Placebo
percent	Purple Grape Juice	Placebo
Compare Change in Platelet Aggregation as Measured by Adenosine Diphosphate (ADP) Between PGJ and Placebo	1.59 ± 16.2	-12.3 ± 17.8

SecondaryCompare 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.

Time frame:: 90-days
Reported as:: percent

Results for this outcome have not been posted.

SecondaryThe Impact of Polymorphism in Haemostatic Genes on Variation in Platelet Function Among Participants Based on Long-term PGJ Consumption.

Time frame:: 90-days
Reported as:: Mean · participants

Results for this outcome have not been posted.

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Grape Juice	—	0/36 (0%)	0/36 (0%)
Grape Juice Placebo	—	0/34 (0%)	0/34 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Grape Juice	Grape Juice Placebo	Total
<=18 years	0	0	0
Between 18 and 65 years	34	34	68
>=65 years	2	0	2

Age Continuous
Age Continuous(years)	Grape Juice	Grape Juice Placebo	Total
Mean	40.8 ± 14.1	42.3 ± 11.4	41.6 ± 12.8

Sex: Female, Male
Sex: Female, Male(Participants)	Grape Juice	Grape Juice Placebo	Total
Female	13	17	30
Male	23	17	40

Region of Enrollment
Region of Enrollment(participants)	Grape Juice	Grape Juice Placebo	Total
United States	36	34	70

Study locations

1 site

Intermountain Medical Center
Murray, Utah 84157, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 16, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00551746
Lead sponsor: Intermountain Health Care, Inc.
Collaborators: Deseret Foundation, Welch's, Inc., ThromboVision, Inc.
First posted: Oct 31, 2007
Start date: Jul 2007
Primary completion: Sep 2009
Completion: Dec 2009
Results posted: Sep 7, 2011
Last update: Sep 16, 2011

Study contacts

Benjamin D Horne, PhD, MPH

principal investigator · Intermountain Medical Center, Murray, UT

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

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