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

Not Applicable

Completed

• Conditions: Mineral Absorption
• Interventions: Dietary Supplement: Liposomal multivitamin/mineral; Dietary Supplement: Standard multivitamin/mineral

• Registration Number: NCT05060367
• Lead Sponsor: Texas Tech University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-10
• Study Start: 2021-09-16
• Study First Submitted QC: 2021-09-17
• Study First Posted: 2021-09-29
• Primary Completion: 2021-11-23
• Study Completion: 2021-11-23
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-08
• Last Update Posted: 2022-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Liposomal multivitamin/mineral condition	Liposomal multivitamin/mineral	Ingestion of novel, liposomal multivitamin/mineral.
Standard multivitamin/mineral condition	Standard multivitamin/mineral	Ingestion of standard multivitamin/mineral.

Primary Outcome Measures

Name	Time	Method
Iron	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
Magnesium	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

Trial Locations

Locations (1)

Department of Kinesiology & Sport Management; 🇺🇸 Lubbock, Texas, United States