Clinical trial NCT01775319: Evaluation of Human Zinc Absorption From Wheat-based Meals
Official title: Evaluation of Human Zinc Absorption From Wheat-based Meals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Zinc Deficiency
Keywords: Zinc
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: HarvestPlus
First posted: 2013-01-24
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fractional zinc absorption from different wheat-based test meals
timeFrame: 3 months
Secondary outcomes:
measure: Zn and C-reactive protein concentration in plasma
timeFrame: 3 months
Other outcomes:
measure: Creatinin
timeFrame: 2 months
Locations:
Study officials:
affiliation: Swiss Federal Institute of Technology
name: Diego Moretti, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.