Clinical Trial to Determine the Bioavailability of Three Different Zinc Preparations

NCT02292303 | Completed

• 1 other identifier: BTS812/14
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Zinc Deficiency

Keywords

Zinc/pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Comparison of pharmacokinetics parameters (AUC, Cmax and Tmax) between zinc-enriched yeast and zinc oxide.

  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.

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

Study Arms (3)

zinc-enriched yeast

EXPERIMENTAL

zinc-enriched yeast capsules

Dietary Supplement: zinc-enriched yeast

zinc oxide

ACTIVE COMPARATOR

zinc oxide capsules

Dietary Supplement: Zinc references

zinc gluconate

ACTIVE COMPARATOR

zinc gluconate capsules

Dietary Supplement: Zinc references

Interventions

zinc-enriched yeast DIETARY_SUPPLEMENT

zinc-enriched yeast

Zinc references DIETARY_SUPPLEMENT

Also known as: zinc oxide; zinc gluconate

zinc gluconate; zinc oxide

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lesaffre International: lead

MeSH Terms

Interventions

Zinc Oxide; gluconic acid

Intervention Hierarchy (Ancestors)

Oxides; Oxygen Compounds; Inorganic Chemicals; Zinc Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2014
• First Posted: November 17, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: February 1, 2015
• Last Updated: June 12, 2018

Record last verified: 2014-11