Trial Outcomes & Findings for The Purple Grape Juice Study (NCT NCT00551746)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

70 participants

Primary outcome timeframe

90-days

Results posted on

2011-09-16

Participant Flow

Recruitment period: August, 2007 to June, 2009

Participant milestones

Participant milestones
Measure	Grape Juice 100% Grape Juice	Grape Juice Placebo Taste, color, and calorically matched grape juice placebo
Overall Study STARTED	36	34
Overall Study COMPLETED	25	26
Overall Study NOT COMPLETED	11	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Purple Grape Juice Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Grape Juice n=36 Participants 100% Grape Juice	Grape Juice Placebo n=34 Participants Taste, color, and calorically matched grape juice placebo	Total n=70 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants	34 Participants n=7 Participants	68 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age Continuous	40.8 years STANDARD_DEVIATION 14.1 • n=5 Participants	42.3 years STANDARD_DEVIATION 11.4 • n=7 Participants	41.6 years STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	17 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	17 Participants n=7 Participants	40 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants	34 participants n=7 Participants	70 participants n=5 Participants

PRIMARY outcome

Timeframe: 90-days

Population: The number of participants evaluated were those who had both a baseline and visit 4 platelet aggregation and platelet-dependant inflammatory marker values

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.

Outcome measures

Outcome measures
Measure	Purple Grape Juice n=23 Participants 100% grape juice	Placebo n=25 Participants Taste, color, and colorically matched grape juice placebo
Compare Change in Platelet Aggregation as Measured by Adenosine Diphosphate (ADP) Between PGJ and Placebo	1.59 percent Standard Deviation 16.2	-12.3 percent Standard Deviation 17.8

SECONDARY outcome

Timeframe: 90-days

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 90-days

Outcome measures

Outcome data not reported

Adverse Events

Grape Juice Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Grape Juice

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Benjamin D Horne, PhD, MPH

Intermountain Healthcare

Phone: 801-507-4708

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place