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CompletedNCT02292303Updated Jun 12, 2018

Clinical Trial to Determine the Bioavailability of Three Different Zinc Preparations

An interventional study of zinc-enriched yeast and Zinc references in Zinc Deficiency, sponsored by Lesaffre International. Completed. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-12.

Sponsored by Lesaffre International · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Zinc Deficiency

Keywords

  • Zinc/pharmacokinetics
03

In context

Lead sponsor

Lesaffre International is the lead sponsor of 12 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    zinc-enriched yeast

    zinc-enriched yeast capsules

    Dietary Supplement: zinc-enriched yeast

  • Active comparator
    zinc oxide

    zinc oxide capsules

    Dietary Supplement: Zinc references

  • Active comparator
    zinc gluconate

    zinc gluconate capsules

    Dietary Supplement: Zinc references

Interventions

  • Dietary supplementzinc-enriched yeast
  • Dietary supplementZinc references

    Also known as: zinc oxide; zinc gluconate

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02292303
Lead sponsor
Lesaffre International
Responsible party
Sponsor
First posted
Nov 17, 2014
Start date
Oct 2014
Primary completion
Dec 2014
Completion
Feb 2015
Last update
Jun 12, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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