Zinc Deficiency
Conditions
Keywords
Zinc
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTBiofortified wheat
Extrinsic label 67Zn (ZnSO4) 0.2mg 70Zn added to the IV dose
DIETARY_SUPPLEMENTFortified wheat
Extrinsic label 67Zn (ZnSO4) 0.2mg 70Zn added to the IV dose
DIETARY_SUPPLEMENTPlacebo
Sponsors
HarvestPlus
Swiss Federal Institute of Technology
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fractional zinc absorption from different wheat-based test meals | 3 months | Fractional zinc absorption (in %) will be assessed with stable isotopes of zinc using a double isotope technique. |
Secondary
| Measure | Time frame |
|---|---|
| Zn and C-reactive protein concentration in plasma | 3 months |
Other
| Measure | Time frame |
|---|---|
| Creatinin | 2 months |
Outcome results
None listed