The Purple Grape Juice Study

Completed · Not applicable

Conditions studied: Cardiovascular Disease

In brief

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.

Key facts

Study ID

NCT00551746

Run by

Intermountain Health Care, Inc.

People needed

70

Starts

2007-07-01

Expected to finish

2009-12-01

Last updated by the study team

2011-09-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Intermountain Medical Center — Murray, Utah, United States

Full record on ClinicalTrials.gov

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