Skip to main content
OpenTrials
Completed

NCT Number: NCT05060367

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mineral Absorption

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Kinesiology & Sport Management

Lubbock, Texas, 79409, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 18 to 65 at time of consent
  • ability to comply with study procedures
  • availability to complete study based on durations of individual visits and scheduling requirements
  • body mass of at least 110 pounds

Exclusion criteria

  • failure to meet any of the aforementioned inclusion criteria
  • presence of a disease or medical condition that could reasonably influence study outcomes or make participation inadvisable
  • use of medication that could reasonably influence study outcomes or make participation inadvisable
  • inability to abstain from medication, supplement, or substance use during the overnight fast and duration of the study visit
  • anticipated inability to provide blood samples (e.g., known difficulty providing blood samples)
  • currently pregnant or breastfeeding, based on self-report
  • allergy that would prevent safe consumption of standardized breakfast or multivitamin product

Treatment and study plan

Liposomal multivitamin/mineral

Dietary Supplement

Two-capsule dose of liposomal multivitamin/mineral that is nutrient-matched to the standard multivitamin/mineral.

Standard multivitamin/mineral

Dietary Supplement

Two-capsule dose of standard multivitamin/mineral that is nutrient-matched to the liposomal multivitamin/mineral.

Primary outcomes

  1. Iron

    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.

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

  2. Iron

    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.

    Maximal concentration (Cmax) of iron in serum

  3. Magnesium

    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.

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

  4. Magnesium

    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.

    Maximal concentration (Cmax) of magnesium in serum

Sponsors and collaborators

Lead sponsor

Texas Tech University

Other

Collaborators

  • Nutraceutical Corporation

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 29, 2021
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.