Clinical Trial to Determine the Bioavailability of Three Different Zinc Preparations

NCT ID: NCT02292303

Last Updated: 2018-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-02-28

Brief Summary

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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

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Conditions

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Zinc Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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zinc-enriched yeast

zinc-enriched yeast capsules

Group Type EXPERIMENTAL

zinc-enriched yeast

Intervention Type DIETARY_SUPPLEMENT

zinc oxide

zinc oxide capsules

Group Type ACTIVE_COMPARATOR

Zinc references

Intervention Type DIETARY_SUPPLEMENT

zinc gluconate

zinc gluconate capsules

Group Type ACTIVE_COMPARATOR

Zinc references

Intervention Type DIETARY_SUPPLEMENT

Interventions

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zinc-enriched yeast

Intervention Type DIETARY_SUPPLEMENT

Zinc references

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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zinc oxide; zinc gluconate

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lesaffre International

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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BTS812/14

Identifier Type: -

Identifier Source: org_study_id

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