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.

Study Overview

• Status: Completed
• Conditions: Mineral Absorption
• Intervention / Treatment: Dietary supplement: Liposomal multivitamin/mineral; Dietary supplement: Standard multivitamin/mineral

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Lubbock, Texas, United States, 79409
      • Department of Kinesiology & Sport Management

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Liposomal multivitamin/mineral condition; Ingestion of novel, liposomal multivitamin/mineral.	Dietary supplement: Liposomal multivitamin/mineral; Two-capsule dose of liposomal multivitamin/mineral that is nutrient-matched to the standard multivitamin/mineral.
ACTIVE_COMPARATOR: Standard multivitamin/mineral condition; Ingestion of standard multivitamin/mineral.	Dietary supplement: Standard multivitamin/mineral; Two-capsule dose of standard multivitamin/mineral that is nutrient-matched to the liposomal multivitamin/mineral.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Iron	Area under the concentration vs. time curve (AUC) for iron in serum	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	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	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.
Magnesium	Maximal concentration (Cmax) of magnesium in serum	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.

Collaborators and Investigators

• Sponsor: Texas Tech University
• Collaborators: Nutraceutical Corporation

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 16, 2021
• Primary Completion (ACTUAL): November 23, 2021
• Study Completion (ACTUAL): November 23, 2021

Study Registration Dates

• First Submitted: September 10, 2021
• First Submitted That Met QC Criteria: September 17, 2021
• First Posted (ACTUAL): September 29, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 10, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2021-527

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No