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| Name | Class |
|---|---|
| Ocean Spray Cranberries, Inc. | INDUSTRY |
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The purpose of this study is to determine the effects of a single dose of cranberry beverage in healthy adults on the kinetic uptake of polyphenol compounds and polyphenol metabolites, and antioxidative and anti-inflammatory activity.
Participants will be randomized based on age, sex and BMI, and will consume a low-polyphenol diet 2 days prior to the intervention. On the day of the study, baseline blood and urine samples will be collected after an overnight fast. Participants will consume the assigned beverage within 15 minutes and blood collected at 2, 4, 8, and 24 h (10 mL/blood draw; total blood volume per period = 50 mL). Urine will be collected for polyphenol analysis during the following periods: 0-3, 3-6, 6-9, 9-12, 12-24 hours. After a one-week washout period, participants will receive their second and then the third beverage in a cross-over design; blood and urine sampling will be repeated at each of the 3 intervention periods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Calorie Cranberry Juice Cocktail | Active Comparator | Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes |
|
| Cranberry Extract Beverage | Active Comparator | Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes |
|
| Non-Cranberry Beverage | Placebo Comparator | Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Calorie Cranberry Juice Cocktail | Other | Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduced Glutathione (GSH) Concentrations in Red Blood Cells | 0, 2, 4, 8, 24 h | |
| Superoxide Dismutase (SOD) Activity in Red Blood Cells | 0, 2, 4, 8, 24 h | |
| Glutathione Peroxidase (GPx) Activity in Red Blood Cells | 0, 2, 4, 8, 24 h | |
| Oxidative Damage to DNA Assessed by Plasma 8-hydroxy-2'-Deoxyguanosine (8-OHdG) | 0, 2, 4, 8, 24 h | |
| C-Reactive Protein (CRP) Concentrations in Plamsa | 0, 2, 4, 8, 24 h | |
| Nitric Oxide (NO) Concentrations in Plamsa | 0, 2, 4, 8, 24 h | |
| Interleukin-1alpha (IL-1a) Concentrations in Plasma | 0, 2, 4, 8, 24 h | |
| Interleukin-1beta (IL-1b) Concentrations in Plasma | 0, 2, 4, 8, 24 h | |
| Interleukin-2 (IL-2) Concentrations in Plasma | 0, 2, 4, 8, 24 h | |
| Interleukin-4 (IL-4) Concentrations in Plasma | 0, 2, 4, 8, 24 h | |
| Interleukin-6 (IL-6) Concentrations in Plasma |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boon P Chew, PhD | Washington State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WSU Bioactives Research Lab | Pullman | Washington | 99164 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | LCJC First, Then CLEB, Then Placebo | First Intervention (1 day) - Low Calorie Cranberry Juice Cocktail (LCJC): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Second Intervention (1 day) - Cranberry Leaf Extract Beverage (CLEB): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Third Intervention (1 day) - Placebo: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes |
| FG001 | LCJC First, Then Placebo, Then CLEB | First Intervention (1 day) - Low Calorie Cranberry Juice Cocktail (LCJC): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Second Intervention (1 day) - Placebo: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Third Intervention (1 day) - Cranberry Leaf Extract Beverage (CLEB): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes |
| FG002 | CLEB First, Then LCJC, Then Placebo | First Intervention (1 day) - Cranberry Leaf Extract Beverage (CLEB): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Second Intervention (1 day) - Low Calorie Cranberry Juice Cocktail (LCJC): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Third Intervention (1 day) - Placebo: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes |
| FG003 | CLEB First, Then Placebo, Then LCJC | First Intervention (1 day) - Cranberry Leaf Extract Beverage (CLEB): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Second Intervention (1 day) - Placebo: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Third Intervention (1 day) - Low Calorie Cranberry Juice Cocktail (LCJC): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes |
| FG004 | Placebo First, Then LCJC, Then CLEB | First Intervention (1 day) - Placebo: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Second Intervention (1 day) - Low Calorie Cranberry Juice Cocktail (LCJC): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Third Intervention (1 day) - Cranberry Leaf Extract Beverage (CLEB): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes |
| FG005 | Placebo First, Then CLEB, Then LCJC | First Intervention (1 day) - Placebo: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Second Intervention (1 day) - Cranberry Leaf Extract Beverage (CLEB): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Third Intervention (1 day) - Low Calorie Cranberry Juice Cocktail (LCJC): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1 Day) |
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| Washout (7 Days) |
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| Second Intervention (1 Day) |
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| Washout (7 Days) |
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| Third Intervention (1 Day) |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All study participants: all participants received all interventions |
| 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 | Reduced Glutathione (GSH) Concentrations in Red Blood Cells | Posted | Mean | Standard Error | mmol/L | 0, 2, 4, 8, 24 h |
|
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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 | Low Calorie Cranberry Juice Cocktail | Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boon P. Chew | Washington State Unviversity | 5093351427 | boonchew@wsu.edu |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Cranberry Extract Beverage | Other | Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes |
|
| Non-Cranberry Beverage | Other | Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes |
|
| 0, 2, 4, 8, 24 h |
| Interleukin-8 (IL-8) Concentrations in Plasma | 0, 2, 4, 8, 24 h |
| Interleukin-10 (IL-10) Concentrations in Plasma | 0, 2, 4, 8, 24 h |
| Interferon-gamma (IFN-y) Concentrations in Plasma | 0, 2, 4, 8, 24 h |
| Tumor Necrosis Factor-alpha (TNF-a) Concentrations in Plasma | 0, 2, 4, 8, 24 h |
| Urinary Anti-bacteria Adhesion Activity | 0, 3, 6, 9, 12, 24 h |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
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| NOT COMPLETED |
|
| COMPLETED |
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| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Non-Cranberry Beverage |
Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes |
|
|
| Primary | Superoxide Dismutase (SOD) Activity in Red Blood Cells | Posted | Mean | Standard Error | mU/mg HgB | 0, 2, 4, 8, 24 h |
|
|
|
| Primary | Glutathione Peroxidase (GPx) Activity in Red Blood Cells | Posted | Mean | Standard Error | mU/mg HgB | 0, 2, 4, 8, 24 h |
|
|
|
| Primary | Oxidative Damage to DNA Assessed by Plasma 8-hydroxy-2'-Deoxyguanosine (8-OHdG) | Posted | Mean | Standard Error | ng/mL | 0, 2, 4, 8, 24 h |
|
|
|
| Primary | C-Reactive Protein (CRP) Concentrations in Plamsa | Posted | Mean | Standard Error | ug/mL | 0, 2, 4, 8, 24 h |
|
|
|
| Primary | Nitric Oxide (NO) Concentrations in Plamsa | Posted | Mean | Standard Error | umol/L | 0, 2, 4, 8, 24 h |
|
|
|
| Primary | Interleukin-1alpha (IL-1a) Concentrations in Plasma | Posted | Mean | Standard Error | pg/mL | 0, 2, 4, 8, 24 h |
|
|
|
| Primary | Interleukin-1beta (IL-1b) Concentrations in Plasma | Posted | Mean | Standard Error | pg/mL | 0, 2, 4, 8, 24 h |
|
|
|
| Primary | Interleukin-2 (IL-2) Concentrations in Plasma | Posted | Mean | Standard Error | pg/mL | 0, 2, 4, 8, 24 h |
|
|
|
| Primary | Interleukin-4 (IL-4) Concentrations in Plasma | Posted | Mean | Standard Error | pg/mL | 0, 2, 4, 8, 24 h |
|
|
|
| Primary | Interleukin-6 (IL-6) Concentrations in Plasma | Posted | Mean | Standard Error | pg/mL | 0, 2, 4, 8, 24 h |
|
|
|
| Primary | Interleukin-8 (IL-8) Concentrations in Plasma | Posted | Mean | Standard Error | pg/mL | 0, 2, 4, 8, 24 h |
|
|
|
| Primary | Interleukin-10 (IL-10) Concentrations in Plasma | Posted | Mean | Standard Error | pg/mL | 0, 2, 4, 8, 24 h |
|
|
|
| Primary | Interferon-gamma (IFN-y) Concentrations in Plasma | Posted | Mean | Standard Error | pg/mL | 0, 2, 4, 8, 24 h |
|
|
|
| Primary | Tumor Necrosis Factor-alpha (TNF-a) Concentrations in Plasma | Posted | Mean | Standard Error | pg/mL | 0, 2, 4, 8, 24 h |
|
|
|
| Primary | Urinary Anti-bacteria Adhesion Activity | Posted | Mean | Standard Error | mg PAC/mg creatinine | 0, 3, 6, 9, 12, 24 h |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Cranberry Leaf Extract Beverage | Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes | 0 | 0 | 0 | 0 |
| EG002 | Non-Cranberry Beverage | Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes | 0 | 0 | 0 | 0 |
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|
| SOD at 4h |
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| SOD at 8h |
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| SOD at 24h |
|
|
| GPx at 4h |
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| GPx at 8h |
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| GPx at 24h |
|
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| 8OHdG at 4h |
|
| 8OHdG at 8h |
|
| 8OHdG at 24h |
|
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| CRP at 4h |
|
| CRP at 8h |
|
| CRP at 24h |
|
|
| NO at 4h |
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| NO at 8h |
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| NO at 24h |
|
|
| IL-1a at 4h |
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| IL-1a at 8h |
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| IL-1a at 24h |
|
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| IL-1b at 4h |
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| IL-1b at 8h |
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| IL-1b at 24h |
|
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| IL-2 at 4h |
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| IL-2 at 8h |
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| IL-2 at 24h |
|
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| IL-4 at 4h |
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| IL-4 at 8h |
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| IL-4 at 24h |
|
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| IL-6 at 4h |
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| IL-6 at 8h |
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| IL-6 at 24h |
|
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| IL-8 at 4h |
|
| IL-8 at 8h |
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| IL-8 at 24h |
|
|
| IL-10 at 4h |
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| IL-10 at 8h |
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| IL-10 at 24h |
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| IFN-y at 4h |
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| IFN-y at 8h |
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| IFN-y at 24h |
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| TNF-a at 4h |
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| TNF-a at 8h |
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| TNF-a at 24h |
|
|
| 6h |
|
| 9h |
|
| 12h |
|
| 24h |
|