Pharmacokinetic Analysis of Nutrient Absorption From a Novel Liposomal Multivitamin/Mineral Formulation

Texas Tech University25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Mineral Absorption

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Iron

Area under the concentration vs. time curve (AUC) for iron in serum

Time frame: 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

Time frame: 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