NCT05060367

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

September 16, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 29, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2021

Completed
Last Updated

August 10, 2022

Status Verified

August 1, 2022

Enrollment Period

2 months

First QC Date

September 10, 2021

Last Update Submit

August 8, 2022

Conditions

Mineral Absorption

Outcome Measures

Primary Outcomes (4)

  • 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.

Study Arms (2)

Liposomal multivitamin/mineral condition

EXPERIMENTAL

Ingestion of novel, liposomal multivitamin/mineral.

Dietary Supplement: Liposomal multivitamin/mineral

Standard multivitamin/mineral condition

ACTIVE COMPARATOR

Ingestion of standard multivitamin/mineral.

Dietary Supplement: Standard multivitamin/mineral

Interventions

Liposomal multivitamin/mineralDIETARY_SUPPLEMENT

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

Liposomal multivitamin/mineral condition
Standard multivitamin/mineralDIETARY_SUPPLEMENT

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

Standard multivitamin/mineral condition

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Kinesiology & Sport Management

Lubbock, Texas, 79409, United States

Location

MeSH Terms

Interventions

Minerals

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Officials

  • Grant M Tinsley, PhD

    Texas Tech University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2021

First Posted

September 29, 2021

Study Start

September 16, 2021

Primary Completion

November 23, 2021

Study Completion

November 23, 2021

Last Updated

August 10, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)