Clinical Trial to Determine the Bioavailability of Three Different Zinc Preparations

Study Overview
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Brief Summary
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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.

Official Title
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Randomized, Monocentric, Double-blind, 3-way-cross-over Clinical Trial to Determine the Bioavailability of Three Different Zinc Preparations

Conditions
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Zinc Deficiency

Intervention / Treatment
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* Dietary Supplement: zinc-enriched yeast
* Dietary Supplement: Zinc references


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: zinc-enriched yeast<br>zinc-enriched yeast capsules | Dietary Supplement: zinc-enriched yeast<br> <br> |
| Active Comparator: zinc oxide<br>zinc oxide capsules | Dietary Supplement: Zinc references<br> <br> * Other names: zinc oxide; zinc gluconate;|
| Active Comparator: zinc gluconate<br>zinc gluconate capsules | Dietary Supplement: Zinc references<br> <br> * Other names: zinc oxide; zinc gluconate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zinc/pharmacokinetics