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Anthocyanins are phytonutrients that provide blue, purple and red colors to fruits and vegetables. The purpose of the study is to determine whether absorption of anthocyanins occurs in the acid pH of the stomach and to determine whether altering stomach pH by use of an over-the-counter medicine, Prilosec TM, alters absorption of anthocyanins from strawberries and blackberries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | Placebo with berries (blackberries + strawberries) |
|
| omeprazole | Experimental | Prilosec (omeprazole) 20.6 mg tablet with berries (blackberries + strawberries) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| omeprazole | Drug | omeprazole 20.6 mg tablet with berries (blackberries + strawberries) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric pH | 1 hour prior to gastric emptying on Day 7 of the given intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beverly Clevidence, Ph. D. | USDA Beltsville Human Nutrition Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USDA's Beltsville Human Nutrition Research Center | Beltsville | Maryland | 20705 | United States |
Discrepancy between actual enrollment and number of participants in participant flow module is due to enrolled participants no longer meeting exclusion criteria (i.e., inability to swallow capsule).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo First, Then Omeprazole | Placebo with berries (blackberries + strawberries), followed by Omeprazole with berries (blackberries + strawberries) |
| FG001 | Omeprazole First, Then Placebo | Prilosec (omeprazole) 20.6 mg tablet with berries (blackberries + strawberries), followed by placebo with berries (blackberries + strawberries) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (7 Days) |
| |||||||||||||
| Washout (7-14 Days) |
| |||||||||||||
| Second Intervention (7 Days) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All participants received both interventions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Gastric pH | Posted | Mean | Standard Deviation | pH | 1 hour prior to gastric emptying on Day 7 of the given intervention |
|
|
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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 | Experimental |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Beverly Clevidence | USDA | 301-504-8367 | beverly.clevidence@ars.usda.gov |
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| ID | Term |
|---|---|
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| placebo |
| Drug |
Placebo with berries (blackberries + strawberries) |
|
| NOT COMPLETED |
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| NOT COMPLETED |
|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Placebo | 0 | 11 | 0 | 11 |
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| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |