Clinical Trial to Determine the Bioavailability of Three Different Zinc Preparations

Not Applicable

Completed

• Conditions: Zinc Deficiency
• Interventions: Dietary Supplement: Zinc references; Dietary Supplement: zinc-enriched yeast

• Registration Number: NCT02292303
• Lead Sponsor: Lesaffre International

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Status Verified: 2014-11
• Study First Submitted: 2014-11-07
• Study First Submitted QC: 2014-11-12
• Study First Posted: 2014-11-17
• Primary Completion: 2014-12
• Study Completion: 2015-02
• Last Update Submitted: 2018-06-11
• Last Update Posted: 2018-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
zinc gluconate	Zinc references	zinc gluconate capsules
zinc oxide	Zinc references	zinc oxide capsules
zinc-enriched yeast	zinc-enriched yeast	zinc-enriched yeast capsules

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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