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This is a prospective, 2-group crossover, randomized, double-blind study to evaluate nutrient absorption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1A - High Vitamin D, Experimental Oil | Experimental | High dose Vitamin D mixed with Experimental Oil |
|
| Group 1B - High Vitamin D, Control Oil | Active Comparator | High Dose Vitamin D mixed with Control Oil |
|
| Group 2A - Low Vitamin D, Experimental Oil | Experimental | Low dose Vitamin D mixed with Experimental Oil |
|
| Group 2B - Low Vitamin D, Control Oil | Active Comparator | Low Dose Vitamin D mixed with Control Oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Oil with Phospholipids | Other | Consumed on white bread |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vitamin D Absorption | Change in area under the curve (AUC) of serum vitamin D for low dose in experimental versus control oil | Time 0 to 24 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Vitamin D Absorption - Peak | Change in Peak serum for vitamin D in experimental versus control oil | Time 0 to 48 Hours |
| Vitamin D Absorption - AUC | Change in AUC for vitamin D in experimental versus control oil |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index | As calculated from height in cm and weight in kg | Visit 1, Baseline Collection |
| Adverse Events | Participant reported adverse events during study duration |
Inclusion Criteria:
Exclusion Criteria:
Use of vitamin D or calcium supplements within 3 weeks prior to the Screening Visit.
Use of a tanning booth/lamp within 3 weeks prior to the Screening Visit.
Travel to sunny location within 3 weeks prior to the Screening Visit.
Consumption of more than 3 alcoholic drinks per day starting 48 hours before the Screening Visit.
Has an allergy or intolerance to any ingredient in the study product.
Participating in another study that has not been approved as a concomitant study by Abbott Nutrition.
Use of the following medications that may have interactions with vitamin D absorption or metabolism:
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| Name | Affiliation | Role |
|---|---|---|
| Steve Hertzler | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walsh University | North Canton | Ohio | 44720 | United States |
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| ID | Term |
|---|---|
| D010743 | Phospholipids |
| ID | Term |
|---|---|
| D008563 | Membrane Lipids |
| D008055 | Lipids |
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| Control Polyunsaturated Oil Blend | Other | Consumed on white bread |
|
| Time 0 to 48 Hours |
| Study Day 1 to Study Day 7 up to 20 Days |