Clinical Trial to Determine the Bioavailability of Three Different Zinc Preparations

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

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.

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