Clinical Trial to Determine the Bioavailability of Three Different Zinc Preparations

Lesaffre

Status: Completed

Conditions: Zinc Deficiency

Treatments: Dietary Supplement: zinc-enriched yeast; Dietary Supplement: Zinc references

Study type: Interventional

Funder types: Industry

Identifiers

NCT02292303

BTS812/14

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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25 participants in 3 patient groups

zinc-enriched yeast

Experimental group

Description:

zinc-enriched yeast capsules

Treatment:

Dietary Supplement: zinc-enriched yeast

zinc oxide

Active Comparator group

Description:

zinc oxide capsules

Treatment:

Dietary Supplement: Zinc references

zinc gluconate

Active Comparator group

Description:

zinc gluconate capsules

Treatment:

Dietary Supplement: Zinc references