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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-01525 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This trial studies how well a group of compounds found in blueberries called anthocyanins are absorbed into the body from 2 different types of blueberry confections (blueberry extract and whole blueberry powder). Blueberries contain several compounds which may be beneficial for human health and prevention of disease. These compounds can be consumed as part of a complex matrix in the whole fruit or also in a simplified matrix in the form of a fruit extract. Studying the absorption and metabolism of these compounds may help researchers understand how they influence health and disease, as well as determining the role of the food matrix on absorption of berry phytochemical.
PRIMARY OBJECTIVES:
I. Compare urinary flavonoids composition, compliance and sensory acceptability of 2 blueberry-based amorphous functional confections one containing blueberry extract and the other of a whole blueberry powder) formulated to deliver the 320 mg of anthocyanins.
II. Assess the effect of blueberry source (extract versus [vs] whole fruit powder) on urinary metabolomics profile.
OUTLINE: Participants are randomized to of 2 groups.
GROUP I: Participants undergo a washout on days -7 to -1 and then consume blueberry extract confection on day 0. Participants undergo a second washout on days 1-7 and then consume blueberry powder confection on day 8.
GROUP II. Participants undergo a washout on days -7 to -1 and then consume blueberry powder confection on day 0. Participants undergo a second washout on days 1-7 and then consume blueberry extract confection on day 8.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (blueberry extract, blueberry powder) | Experimental | Participants undergo a washout on days -7 to -1 and then consume blueberry extract confection on day 0. Participants undergo a second washout on days 1-7 and then consume blueberry powder confection on day 8. |
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| Group II (blueberry powder, blueberry extract) | Experimental | Participants undergo a washout on days -7 to -1 and then consume blueberry powder confection on day 0. Participants undergo a second washout on days 1-7 and then consume blueberry extract confection on day 8. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blueberry Powder Food Product | Other | Consume blueberry powder confection |
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| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | Means +/- SD (standard deviation) will be used to express the results from acceptability tests, and differences in acceptability of the two confections will be determined using paired t tests using the SPSS statistical software package. | Day 0 of each arm |
| Acceptability | Means +/- SD (standard deviation) will be used to express the results from acceptability tests, and differences in acceptability of the two confections will be determined using paired t tests using the SPSS statistical software package. | Day 8 of each arm |
| Bioavailability of the various berry interventions | Will measure bioavailability of the various berry interventions using high performance liquid chromatography (HPLC) analysis of blueberry phytochemicals and metabolites in urine at the day 1 timepoint, after consumption of the test product. Baseline comparisons for anthocyanins found in urine between trials will be performed a paired t-test. Total anthocyanins in 24-hour urine after consumption of one blueberry treatment will be compared to each participant's baseline urine and to total anthocyanins after consumption of the blueberry treatment in a paired t-test. | Day 1 of each arm |
| Bioavailability of the various berry interventions | Will measure bioavailability of the various berry interventions using high performance liquid chromatography (HPLC) analysis of blueberry phytochemicals and metabolites in urine at the day 8 timepoints. Baseline comparisons for anthocyanins found in urine between trials will be performed a paired t-test. Total anthocyanins in 24-hour urine after consumption of one blueberry treatment will be compared to each participant's baseline urine and to total anthocyanins after consumption of the blueberry treatment in a paired t-test. | Day 8 of each arm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yael Vodovotz | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| Dietary Intervention | Other | Consume blueberry extract confection |
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| Questionnaire Administration | Other | Ancillary studies |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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