Ignite Creation Date:
2024-05-05 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00551746
Status:
COMPLETED
Last Update Posted:
2011-09-16
First Post:
2007-10-29
Brief Title:
The Purple Grape Juice Study
Sponsor:
Intermountain Health Care Inc
Organization:
Intermountain Health Care Inc
Study Overview
Official Title:
Anti-thrombotic Effects of Long Term Consumption of Purple Grape Juice in Healthy People
Status:
COMPLETED
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
The study treatment period will be 90 days 13 weeks or 3 months and the treatment dose will be 7 mLkgday 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 collagenepinephrine PMA and TRAP Each of these aggregation inducers target a separate platelet activation pathway
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 collagenepinephrine PMA and TRAP Each of these aggregation inducers target a separate platelet activation pathway
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None