Clinical Trial to Determine the Bioavailability of Three Different Zinc Preparations

June 11, 2018 updated by: Lesaffre International

Randomized, Monocentric, Double-blind, 3-way-cross-over Clinical Trial to Determine the Bioavailability of Three Different Zinc Preparations

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: zinc-enriched yeast
zinc-enriched yeast capsules
Dietary supplement: zinc-enriched yeast
ACTIVE_COMPARATOR: zinc oxide
zinc oxide capsules
Dietary supplement: Zinc references
Other Names:
  • zinc oxide; zinc gluconate
ACTIVE_COMPARATOR: zinc gluconate
zinc gluconate capsules
Dietary supplement: Zinc references
Other Names:
  • zinc oxide; zinc gluconate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline (0 min); 30; 60; 90;120; 150; 180; 210; 240; 300 and 360 min

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Baseline (0 min); 30; 60; 90;120; 150; 180; 210; 240; 300 and 360 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lesaffre International

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

February 1, 2015

Study Registration Dates

First Submitted

November 7, 2014

First Submitted That Met QC Criteria

November 12, 2014

First Posted (ESTIMATE)

November 17, 2014

Study Record Updates

Last Update Posted (ACTUAL)

June 12, 2018

Last Update Submitted That Met QC Criteria

June 11, 2018

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTS812/14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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