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
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.
1. The volunteer (male or non-pregnant female, any ethnicity) must be > 18 years of age.
2. The volunteer has no history of a physician diagnosis of atherosclerosis such as
carotid, peripheral, or coronary artery disease (CAD).
3. The volunteer has no history of a physician diagnosis of pulmonary embolism (PE), MI,
4. The volunteer must sign a written informed consent, prior to the procedure, using a
form that is approved by the local Institutional Review Board.
1. A diagnosis if diabetes mellitus.
2. The limitations for specific medications, supplements and food items are exceeded as
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
- non-grape juices • garlic • broccoli
- apples • any type of berries • onions Volunteer is pregnant or lactating at the time
1. 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).
2. 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.
3. 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.
Benjamin D Horne, PhD, MPH
Intermountain Medical Center, Murray, UT