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.

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Key information

Conditions

Zinc Deficiency

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

zinc-enriched yeast

Dietary Supplement

Zinc references

Dietary Supplement

Other names: zinc oxide; zinc gluconate

Primary outcomes

Comparison of pharmacokinetics parameters (AUC, Cmax and Tmax) between zinc-enriched yeast and zinc oxide.

Time frame: Baseline (0 min); 30; 60; 90;120; 150; 180; 210; 240; 300 and 360 min

Secondary outcomes

Comparison of pharmacokinetics parameters (AUC, Cmax and Tmax) between zinc-enriched yeast and zinc gluconate.

Time frame: Baseline (0 min); 30; 60; 90;120; 150; 180; 210; 240; 300 and 360 min

Sponsors and collaborators

Lead sponsor

Lesaffre International

Industry

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2015
First posted: Nov 17, 2014
Registry last updated: Jun 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed