Overview

This trial is active, not recruiting.

Condition zinc deficiency
Treatments zinc-enriched yeast, zinc references
Sponsor Lesaffre International
Start date October 2014
End date December 2014
Trial size 26 participants
Trial identifier NCT02292303, BTS812/14

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-availability study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
zinc-enriched yeast capsules
zinc-enriched yeast
(Active Comparator)
zinc oxide capsules
zinc references zinc oxide; zinc gluconate
(Active Comparator)
zinc gluconate capsules
zinc references zinc oxide; zinc gluconate

Primary Outcomes

Measure
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

Measure
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

Eligibility Criteria

Male or female participants from 20 years up to 50 years old.

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

Additional Information

Official title Randomized, Monocentric, Double-blind, 3-way-cross-over Clinical Trial to Determine the Bioavailability of Three Different Zinc Preparations
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Lesaffre International.