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Clinical Trial to Determine the Bioavailability of Three Different Zinc Preparations

Sponsor
Lesaffre International (Industry)
Overall Status
Completed
CT.gov ID
NCT02292303
Collaborator
(none)
25
Enrollment
3
Arms
4
Duration (Months)

Study Details

Study Description

Brief Summary

The main objective of this clinical is to get information on pharmacokinetics of zinc-enriched yeast.The bioavailability of the yeast enriched with zinc will be compared to two selected zinc salts used in food supplements that are zinc oxide and zinc gluconate.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: zinc-enriched yeast
  • Dietary Supplement: Zinc references
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Randomized, Monocentric, Double-blind, 3-way-cross-over Clinical Trial to Determine the Bioavailability of Three Different Zinc Preparations
Study Start Date :
Oct 1, 2014
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Feb 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: zinc-enriched yeast

zinc-enriched yeast capsules

Dietary Supplement: zinc-enriched yeast
Active Comparator: zinc oxide

zinc oxide capsules

Dietary Supplement: Zinc references
Other Names:
  • zinc oxide; zinc gluconate

    		•
    Active Comparator: zinc gluconate

    zinc gluconate capsules

    Dietary Supplement: Zinc references
    Other Names:
  • zinc oxide; zinc gluconate

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Comparison of pharmacokinetics parameters (AUC, Cmax and Tmax) between zinc-enriched yeast and zinc oxide. [Baseline (0 min); 30; 60; 90;120; 150; 180; 210; 240; 300 and 360 min]

    Secondary Outcome Measures

    1. Comparison of pharmacokinetics parameters (AUC, Cmax and Tmax) between zinc-enriched yeast and zinc gluconate. [Baseline (0 min); 30; 60; 90;120; 150; 180; 210; 240; 300 and 360 min]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Subject is able and willing to sign the Informed Consent Form prior to screening evaluations

    • Sex: female (premenopausal), male

    • Age: 20 - 50 years

    • BMI ≥19 or ≤30 kg/m²

    • Non-smoker

    • Subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry, hematology

    Exclusion Criteria:

    • Relevant history or presence of any medical disorder, potentially interfering with this trial

    • For this trial clinically relevant abnormal laboratory, ECG, vital signs or physical findings at screening

    • Migraine or regular headache, intense premenstrual symptoms

    • Coffee consumption >3 cups / day

    • Blood donation within 2 months prior to trial start or during trial

    • Regular intake of mineral supplements within 4 weeks prior to trial start or during trial

    • Chronic intake of substances affecting the intestinal absorption of zinc

    • Vegetarians / vegans

    • Drug-, alcohol- and medication abuses

    • Known HIV-infection

    • Known acute or chronic hepatitis B and C infection

    • Relevant allergy or known hypersensitivity against compounds of the study preparations, for example lactose intolerance

    • Known pregnancy, breast feeding or intention to become pregnant during the study

    • Participation in another clinical trial within the last 4 weeks and concurrent participation in another clinical trial

    • Not anticipating any planned changes in lifestyle for the duration of the study

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Lesaffre International

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lesaffre International
    ClinicalTrials.gov Identifier:
    NCT02292303
    Other Study ID Numbers:
    • BTS812/14
    First Posted:
    Nov 17, 2014
    Last Update Posted:
    Jun 12, 2018
    Last Verified:
    Nov 1, 2014
    Keywords provided by Lesaffre International
    Zinc/pharmacokinetics
    Additional relevant MeSH terms:
    Zinc
    Zinc Oxide

    Study Results

    No Results Posted as of Jun 12, 2018