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

Texas Tech University

Status: Completed

Conditions: Mineral Absorption

Treatments: Dietary Supplement: Standard multivitamin/mineral; Dietary Supplement: Liposomal multivitamin/mineral

Study type: Interventional

Funder types: Other

Identifiers

NCT05060367

2021-527

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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25 participants in 2 patient groups

Liposomal multivitamin/mineral condition

Experimental group

Description:

Ingestion of novel, liposomal multivitamin/mineral.

Treatment:

Dietary Supplement: Liposomal multivitamin/mineral

Standard multivitamin/mineral condition

Active Comparator group

Description:

Ingestion of standard multivitamin/mineral.

Treatment:

Dietary Supplement: Standard multivitamin/mineral