Mineral Absorption
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTLiposomal multivitamin/mineral
Two-capsule dose of liposomal multivitamin/mineral that is nutrient-matched to the standard multivitamin/mineral.
DIETARY_SUPPLEMENTStandard multivitamin/mineral
Two-capsule dose of standard multivitamin/mineral that is nutrient-matched to the liposomal multivitamin/mineral.
Sponsors
Nutraceutical Corporation
Texas Tech University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. age 18 to 65 at time of consent 2. ability to comply with study procedures 3. availability to complete study based on durations of individual visits and scheduling requirements 4. body mass of at least 110 pounds
Exclusion criteria
1. failure to meet any of the aforementioned inclusion criteria 2. presence of a disease or medical condition that could reasonably influence study outcomes or make participation inadvisable 3. use of medication that could reasonably influence study outcomes or make participation inadvisable 4. inability to abstain from medication, supplement, or substance use during the overnight fast and duration of the study visit 5. anticipated inability to provide blood samples (e.g., known difficulty providing blood samples) 6. currently pregnant or breastfeeding, based on self-report 7. allergy that would prevent safe consumption of standardized breakfast or multivitamin product
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Iron | 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. | Area under the concentration vs. time curve (AUC) for iron in serum |
| Magnesium | 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. | Area under the concentration vs. time curve (AUC) for magnesium in serum |
Countries
United States
Outcome results
None listed