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Vitamin Gum Pharmacokinetics

NCT03230396 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-08-08

No results posted yet for this study

Summary

The present study will investigate the oral release and systemic pharmacokinetics of a panel water- and fat-soluble vitamins from two commercially-produced chewing gum formulations. Vitaball, Inc. (Ft. Thomas, KY) markets a line of vitamin-fortified gums. These products include Vitamingum Sport and Vitamingum Fresh, which are marketed to different consumer populations. There is currently no available data on the release of vitamins from these products in the oral cavity or the impact of chewing these products on plasma levels of the component vitamins following acute administration. The investigators hypothesize that these chewing gum products will increase both salivary and plasma levels of the component vitamins. The present study has two major objectives:

1. To determine the extent to which a subset of water-soluble and fat-soluble vitamins in two different Vitamingum products are released from the gum matrix and into the saliva as healthy human subjects chew the gum.
2. To determine the extent to which chewing Vitamingum can acutely influence plasma levels of a subset of water-soluble and fat-soluble vitamins in a population of healthy human subjects.

The test articles are commercially-marketed products and are currently available to participants outside the study (http://chewvitamingum.com). The present study is not intended to develop a treatment for a particular disease, but rather to determine if the vitamin components of these commercially-produced chewing gum products are bioaccessible or bioavailable. Vitamin supplements administered as tablets, capsules, caplets, or gummies might be regarded as the "standard of care".

Conditions

  • Nutrient Pharmacokinetics

Interventions

DIETARY_SUPPLEMENT

Vitamingum Sport

Vitamin -supplemented chewing gum

DIETARY_SUPPLEMENT

Vitamingum Immunity

Vitamin -supplemented chewing gum

DIETARY_SUPPLEMENT

Placebo

Control chewing gum. No vitamin content.

Sponsors & Collaborators

  • Vitaball, Inc.

    collaborator UNKNOWN

  • Penn State University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-13
Primary Completion
2015-07-01
Completion
2015-07-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03230396 on ClinicalTrials.gov