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Trial record 28 of 228 for:    yeast

Clinical Trial to Determine the Bioavailability of Three Different Zinc Preparations

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ClinicalTrials.gov Identifier: NCT02292303
Recruitment Status : Completed
First Posted : November 17, 2014
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Lesaffre International

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.

Condition or disease Intervention/treatment Phase
Zinc Deficiency Dietary Supplement: zinc-enriched yeast Dietary Supplement: Zinc references Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Monocentric, Double-blind, 3-way-cross-over Clinical Trial to Determine the Bioavailability of Three Different Zinc Preparations
Study Start Date : October 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


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 Name: zinc oxide; zinc gluconate

Active Comparator: zinc gluconate
zinc gluconate capsules
Dietary Supplement: Zinc references
Other Name: zinc oxide; zinc gluconate




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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Responsible Party: Lesaffre International
ClinicalTrials.gov Identifier: NCT02292303     History of Changes
Other Study ID Numbers: BTS812/14
First Posted: November 17, 2014    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: November 2014
Keywords provided by Lesaffre International:
Zinc/pharmacokinetics
Additional relevant MeSH terms:
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Zinc
Zinc Oxide
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Dermatologic Agents
Sunscreening Agents
Radiation-Protective Agents
Protective Agents