Clinical trial NCT05060367: Pharmacokinetic Analysis of Nutrient Absorption From a Novel Liposomal Multivitamin/Mineral Formulation
Official title: Pharmacokinetic Analysis of Nutrient Absorption From a Novel Liposomal Multivitamin/Mineral Formulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mineral Absorption
Lead sponsor: Texas Tech University
Sponsor class: OTHER
Collaborators: name: Nutraceutical Corporation
First posted: 2021-09-29
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Iron
timeFrame: 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.
measure: Iron
timeFrame: 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.
measure: Magnesium
timeFrame: 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.
measure: Magnesium
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Department of Kinesiology & Sport Management
state: Texas
Study officials:
affiliation: Texas Tech University
name: Grant M Tinsley, PhD
role: PRINCIPAL_INVESTIGATOR
References: