Evaluation of Human Zinc Absorption From Wheat-based Meals

Not Applicable

Completed

• Conditions: Zinc Deficiency
• Interventions: Dietary Supplement: Biofortified wheat; Dietary Supplement: Placebo; Dietary Supplement: Fortified wheat

• Registration Number: NCT01775319
• Lead Sponsor: Swiss Federal Institute of Technology

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.

Study Timeline

• Study First Submitted: 2013-01-22
• Study First Submitted QC: 2013-01-23
• Study First Posted: 2013-01-24
• Study Start: 2013-02
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-13
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Biofortified wheat	Biofortified wheat	Biofortified wheat
Control wheat	Placebo	Control wheat with low level of Zn
Fortified wheat	Fortified wheat	Wheat fortified before consumption

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Zn and C-reactive protein concentration in plasma	3 months