NCT05060367|Completed
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Sponsor study identifier
interventional
25
1 country
1
Study Start
September 16, 2021
Actual (reported)Primary Completion
November 23, 2021
Actual (reported)Study Completion
November 23, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 23, 2021
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 10, 2021
Actual (reported)September 16, 2021
Actual (reported)September 29, 2021
Actual (reported)November 23, 2021
Actual (reported)November 23, 2021
Actual (reported)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.
Ingestion of novel, liposomal multivitamin/mineral.
Ingestion of standard multivitamin/mineral.
Two-capsule dose of liposomal multivitamin/mineral that is nutrient-matched to the standard multivitamin/mineral.
Two-capsule dose of standard multivitamin/mineral that is nutrient-matched to the liposomal multivitamin/mineral.
Department of Kinesiology & Sport Management
Lubbock, Texas, 79409, United States
Grant M Tinsley, PhD
Texas Tech University
25 participants (actual enrollment reported by the registry).
First Submitted
September 10, 2021
First Posted
September 29, 2021
Study Start
September 16, 2021
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
November 23, 2021
Actual (reported)Study Completion
November 23, 2021
Actual (reported)Last Updated
August 10, 2022
Record last verified: 2022-08
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Source: ClinicalTrials.gov.
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