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| Name | Class |
|---|---|
| Nutraceutical Corporation | UNKNOWN |
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This project is a randomized crossover trial examining the pharmacokinetic profiles of standard and liposomal multivitamin/mineral (MVM) formulations in healthy adults. Each participant will complete two research visits, which will be identical except for which MVM product is consumed. At each visit, participants will report to the laboratory after an overnight fast. After a baseline blood sample is collected, the MVM product will be consumed alongside a standardized breakfast. At 2-, 4-, and 6-hours post-ingestion, additional blood samples will be collected. Concentrations of representative minerals will be analyzed to determine whether differential nutrient absorption is observed with the liposomal MVM as compared to the standard MVM product. The results of this study will provide information about a novel liposomal MVM formulation and will inform future research and commercial applications of this technology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal multivitamin/mineral condition | Experimental | Ingestion of novel, liposomal multivitamin/mineral. |
|
| Standard multivitamin/mineral condition | Active Comparator | Ingestion of standard multivitamin/mineral. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal multivitamin/mineral | Dietary Supplement | Two-capsule dose of liposomal multivitamin/mineral that is nutrient-matched to the standard multivitamin/mineral. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Iron | Area under the concentration vs. time curve (AUC) for iron in serum | The AUC value will be calculated using data from four time points: immediately prior to multivitamin/mineral ingestion and 2, 4, and 6 hours after ingestion of multivitamin/mineral. |
| Iron | Maximal concentration (Cmax) of iron in serum | The Cmax value will be determined as the highest concentration observed from four time points: immediately prior to multivitamin/mineral ingestion and 2, 4, and 6 hours after ingestion of multivitamin/mineral. |
| Magnesium | Area under the concentration vs. time curve (AUC) for magnesium in serum | The AUC value will be calculated using data from four time points: immediately prior to multivitamin/mineral ingestion and 2, 4, and 6 hours after ingestion of multivitamin/mineral. |
| Magnesium | Maximal concentration (Cmax) of magnesium in serum | The Cmax value will be determined as the highest concentration observed from four time points: immediately prior to multivitamin/mineral ingestion and 2, 4, and 6 hours after ingestion of multivitamin/mineral. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grant M Tinsley, PhD | Texas Tech University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Kinesiology & Sport Management | Lubbock | Texas | 79409 | United States |
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| ID | Term |
|---|---|
| D008903 | Minerals |
| ID | Term |
|---|---|
| D007287 | Inorganic Chemicals |
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| Standard multivitamin/mineral | Dietary Supplement | Two-capsule dose of standard multivitamin/mineral that is nutrient-matched to the liposomal multivitamin/mineral. |
|