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

Mineral Absorption Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05060367
• Other study ID #: 2021-527
• Status: Completed
• Phase: N/A
• Start date: September 16, 2021
• Est. completion date: November 23, 2021

Study information

• Verified date: August 2022
• Source: Texas Tech University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 23, 2021
• Est. primary completion date: November 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Mineral Absorption

Intervention

Dietary Supplement:
• Liposomal multivitamin/mineral
Two-capsule dose of liposomal multivitamin/mineral that is nutrient-matched to the standard multivitamin/mineral.
• Standard multivitamin/mineral
Two-capsule dose of standard multivitamin/mineral that is nutrient-matched to the liposomal multivitamin/mineral.

Locations

Country	Name	City	State
United States	Department of Kinesiology & Sport Management	Lubbock	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Texas Tech University	Nutraceutical Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.