Clinical Trial to Determine the Bioavailability of Three Different Zinc Preparations

Zinc Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02292303
• Other study ID #: BTS812/14
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: February 2015

Study information

• Verified date: November 2014
• Source: Lesaffre International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Zinc Deficiency

Intervention

Dietary Supplement:
• zinc-enriched yeast

• Zinc references

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lesaffre International

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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