The Purple Grape Juice Study

NCT00551746 | Completed Results

• 1 other identifier: 128-126
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Disease

Keywords

purple grape juice; antioxidants; platelet aggregation; anti-thrombotic

Outcome Measures

Primary Outcomes (1)

• 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.

  90-days

Secondary Outcomes (2)

• Compare Platelet Inhibitory Pathways of ADP,TRAP, PMA, Arachadonic Acid Between PGJ and Placebo.

  90-days

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

  90-days

Study Arms (2)

1

ACTIVE COMPARATOR

Grape Juice

Dietary Supplement: Purple Grape Juice

2

PLACEBO COMPARATOR

Grape Juice Placebo

Dietary Supplement: Purple Grape Juice

Interventions

Purple Grape Juice DIETARY_SUPPLEMENT

Grape Juice

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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.

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead
• Deseret Foundation: collaborator
• Welch's, Inc.: collaborator
• ThromboVision, Inc.: collaborator

Study Sites (1)

Intermountain Medical Center

Murray, Utah, 84157, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Results Point of Contact

• Title: Benjamin D Horne, PhD, MPH
• Organization: Intermountain Healthcare

Benjamin.Horne@imail.org

801-507-4708

Study Officials

• Benjamin D Horne, PhD, MPH

  Intermountain Medical Center, Murray, UT

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 29, 2007
• First Posted: October 31, 2007
• Study Start: July 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: December 1, 2009
• Last Updated: September 16, 2011
• Results First Posted: September 7, 2011

Record last verified: 2011-09

Locations

US (1)