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Researchers at the University of Prince Edward Island want to learn about the health effects of wild blueberry juice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wild blueberry juice | Experimental | 240 ml wild blueberry juice |
|
| Placebo wild blueberry juice | Placebo Comparator | 240 ml placebo wild blueberry juice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wild blueberry juice | Other |
| ||
| Placebo wild blueberry juice |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | Systolic blood pressure | Up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose | Plasma blood glucose concentrations | Up to 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Gottschall-Pass, PhD, RD | University of Prince Edward Island | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Prince Edward Island, Health Sciences | Charlottetown | Prince Edward Island | C1A 4P3 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32153825 | Derived | Stote KS, Sweeney MI, Kean T, Baer DJ, Novotny JA, Shakerley NL, Chandrasekaran A, Carrico PM, Melendez JA, Gottschall-Pass KT. The effects of 100% wild blueberry (Vaccinium angustifolium) juice consumption on cardiometablic biomarkers: a randomized, placebo-controlled, crossover trial in adults with increased risk for type 2 diabetes. BMC Nutr. 2017 May 25;3:45. doi: 10.1186/s40795-017-0164-0. eCollection 2017. |
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20 of the 74 participants were randomized. Of those not randomized, 49 did not meet the inclusion criteria and 5 declined to participate.
74 individuals were screened for eligibility from the greater Charlottetown, Prince Edward Island, Canada area from March 2014 to May 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Wild Blueberry Juice First, Then Placebo | 240 ml Wild Blueberry Juice daily first in intervention period and 240 ml Placebo beverage daily in second intervention period (after washout period) |
| FG001 | Placebo First, Then Wild Blueberry Juice | 240 ml Placebo beverage daily in first intervention period and 240 ml Wild Blueberry Juice daily in second intervention period (after washout period). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (7 Days) |
| |||||||||||||
| Washout Period (8 Days) |
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| Second Intervention (7 Days) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes groups randomized to receive Wild Blueberry Juice first and Placebo first |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Blood Pressure | Systolic blood pressure | Posted | Mean | Standard Error | mm Hg | Up to 4 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Wild Blueberry Juice | 240 ml Wild Blueberry Juice daily in either first intervention period or second intervention period |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kim S. Stote PhD, MPH, RD | University of Prince Edward Island | 518-587-2100 | 2873 | Kim.Stote@esc.edu |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Other |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | 1 participant was randomized but did not start the study | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Glucose | Plasma blood glucose concentrations | Posted | Mean | Standard Error | mmol/L | Up to 4 weeks |
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| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Placebo | 240 ml Placebo beverage daily in either the first intervention period or second intervention period | 0 | 19 | 0 | 19 |
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