Evaluation of Human Zinc Absorption From Wheat-based Meals

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.

Study Overview

• Status: Completed
• Conditions: Zinc Deficiency
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Biofortified wheat; Dietary supplement: Fortified wheat

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
Creatinin	2 months

Collaborators and Investigators

• Sponsor: Swiss Federal Institute of Technology
• Collaborators: HarvestPlus
• Investigators: Principal Investigator: Diego Moretti, PhD, Swiss Federal Institute of Technology

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: January 22, 2013
• First Submitted That Met QC Criteria: January 23, 2013
• First Posted (Estimate): January 24, 2013

Study Record Updates

• Last Update Posted (Estimate): April 14, 2016
• Last Update Submitted That Met QC Criteria: April 13, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Zinc
• Other Study ID Numbers: HNL/CTC_Zn_wheat; KEK-ZH-2012-0483 (Other Identifier: KEK-Zurich)