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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02292303

Enrollment

Registered

2014-11-17

Start date

2014-10-31

Completion date

2015-02-28

Last updated

2018-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Zinc Deficiency

Keywords

Zinc/pharmacokinetics

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.

Interventions

DIETARY_SUPPLEMENTzinc-enriched yeast

DIETARY_SUPPLEMENTZinc references

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 50 Years

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

Design outcomes

Primary

Measure	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

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026