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

• Sponsor: Texas Tech University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05060367
• Collaborator: Nutraceutical Corporation (Other)
• Enrollment: 25
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.2
• Patients Per Site Per Month: 11.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mineral Absorption	Dietary Supplement: Liposomal multivitamin/mineral; Dietary Supplement: Standard multivitamin/mineral	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Pharmacokinetic Analysis of Nutrient Absorption From a Novel Liposomal Multivitamin/Mineral Formulation
• Actual Study Start Date: Sep 16, 2021
• Actual Primary Completion Date: Nov 23, 2021
• Actual Study Completion Date: Nov 23, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Iron [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 [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 [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Kinesiology & Sport Management	Lubbock	Texas	United States	79409

Sponsors and Collaborators

• Texas Tech University
• Nutraceutical Corporation

Investigators

• Principal Investigator: Grant M Tinsley, PhD, Texas Tech University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Texas Tech University
• ClinicalTrials.gov Identifier: NCT05060367
• Other Study ID Numbers: 2021-527
• First Posted: Sep 29, 2021
• Last Update Posted: Aug 10, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 10, 2022