Evaluation of Human Zinc Absorption From Wheat-based Meals

Federal Institute of Technology (ETH) Zurich

Status: Completed

Conditions: Zinc Deficiency

Treatments: Dietary Supplement: Fortified wheat; Dietary Supplement: Biofortified wheat; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01775319

KEK-ZH-2012-0483 (Other Identifier)

HNL/CTC_Zn_wheat

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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54 participants in 3 patient groups, including a placebo group

Biofortified wheat

Active Comparator group

Description:

Biofortified wheat

Treatment:

Dietary Supplement: Biofortified wheat

Control wheat

Placebo Comparator group

Description:

Control wheat with low level of Zn

Treatment:

Dietary Supplement: Placebo

Fortified wheat

Active Comparator group

Description:

Wheat fortified before consumption

Treatment:

Dietary Supplement: Fortified wheat