Evaluation of Human Zinc Absorption From Wheat-based Meals

Study Overview
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Brief Summary
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Study part 1 and 2 Assessment of Zn absorption from regular and biofortified wheat: stable isotope absorption studies in women of childbearing age consuming test meals prepared from either the biofortified Zn wheat, regular wheat or post-harvest fortified wheat at two different extraction rates. 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.

Detailed Description
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The overall goal of study part 1 and 2 is to evaluate and compare the fractional and absolute Zn absorption from biofortified wheat cultivar (60 ppm Zn) to regular wheat (28 ppm Zn) and to post harvest fortified wheat (60 ppm Zn) for a total of 3 test meals per study. The studies will be conducted with products based on wheat with high extraction rate (study part 1) and medium extraction rate (study part 2) in two separate groups of women of childbearing age. 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.

Official Title
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Evaluation of Human Zinc Absorption From Wheat-based Meals

Conditions
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Zinc Deficiency

Intervention / Treatment
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* Dietary Supplement: Biofortified wheat
* Dietary Supplement: Fortified wheat
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female, 18 to 45 years old (Study part 1 and 2). Female or male, 18 to 45 years old (Study part 3) Body Mass Index in the range of 18.5 to 25 kg/m2 Signed informed consent Exclusion Criteria: Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, anemia, hepatitis, hypertension, cancer or cardiovascular diseases (according to the subjects own statement) 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Biofortified wheat<br>Biofortified wheat | Dietary Supplement: Biofortified wheat<br>* Extrinsic label 67Zn (ZnSO4) 0.2mg 70Zn added to the IV dose<br>* Other names: Esperia;|
| Placebo Comparator: Control wheat<br>Control wheat with low level of Zn | Dietary Supplement: Placebo<br> <br> |
| Active Comparator: Fortified wheat<br>Wheat fortified before consumption | Dietary Supplement: Fortified wheat<br>* Extrinsic label 67Zn (ZnSO4) 0.2mg 70Zn added to the IV dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fractional zinc absorption from different wheat-based test meals | Fractional zinc absorption (in %) will be assessed with stable isotopes of zinc using a double isotope technique. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Zn and C-reactive protein concentration in plasma |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zinc