Evaluation of Human Zinc Absorption From Wheat-based Meals
NCT ID: NCT01775319
Last Updated: 2016-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
54 participants
INTERVENTIONAL
2013-02-28
2014-03-31
Brief Summary
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Study part 3 Assessment of Zn absorption from intrinsically and extrinsically labeled wheat: stable isotope absorption studies in women of childbearing age, or men, consuming test meals prepared from either intrinsically labeled Zn biofortified wheat, regular wheat or post-harvest fortified wheat extrinsically labeled immediately before consumption.
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Detailed Description
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The goal of study part 3 is to investigate the difference of absorption measurements between intrinsically and extrinsically labeled biofortified wheat. The label of the test meals will have the same nature as the fortificant itself (extrinsic vs intrinsic), for a total of 3 test meals.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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Biofortified wheat
Biofortified wheat
Biofortified wheat
Extrinsic label 67Zn (ZnSO4) 0.2mg 70Zn added to the IV dose
Control wheat
Control wheat with low level of Zn
Placebo
Fortified wheat
Wheat fortified before consumption
Fortified wheat
Extrinsic label 67Zn (ZnSO4) 0.2mg 70Zn added to the IV dose
Interventions
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Biofortified wheat
Extrinsic label 67Zn (ZnSO4) 0.2mg 70Zn added to the IV dose
Fortified wheat
Extrinsic label 67Zn (ZnSO4) 0.2mg 70Zn added to the IV dose
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body Mass Index in the range of 18.5 to 25 kg/m2
* Signed informed consent
Exclusion Criteria
* Gluten intolerance, celiac disease
* Continuous/long-term use of medication during the whole study (except for contraceptives)
* Vegans
* Consumption of mineral and vitamin supplements within 2 weeks prior to 1st test meal administration
* Smoking
* Pregnancy (Urine pregnancy test shall be performed before each test meal administration)
* Lactating
* Earlier participation in a study using Zn stable isotopes or participation in any other clinical study within the last 30 days
18 Years
45 Years
ALL
Yes
Sponsors
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HarvestPlus
OTHER
Swiss Federal Institute of Technology
OTHER
Responsible Party
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Prof. Michael B. Zimmermann
Prof. Dr.
Principal Investigators
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Diego Moretti, PhD
Role: PRINCIPAL_INVESTIGATOR
Swiss Federal Institute of Technology
References
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Signorell C, Zimmermann MB, Cakmak I, Wegmuller R, Zeder C, Hurrell R, Aciksoz SB, Boy E, Tay F, Frossard E, Moretti D. Zinc Absorption From Agronomically Biofortified Wheat Is Similar to Post-Harvest Fortified Wheat and Is a Substantial Source of Bioavailable Zinc in Humans. J Nutr. 2019 May 1;149(5):840-846. doi: 10.1093/jn/nxy328.
Other Identifiers
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KEK-ZH-2012-0483
Identifier Type: OTHER
Identifier Source: secondary_id
HNL/CTC_Zn_wheat
Identifier Type: -
Identifier Source: org_study_id
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