Evaluation of Human Zinc Absorption From Wheat-based Meals

NCT ID: NCT01775319

Last Updated: 2016-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-03-31

Brief Summary

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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

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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.

Conditions

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Zinc Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Biofortified wheat

Biofortified wheat

Group Type ACTIVE_COMPARATOR

Biofortified wheat

Intervention Type DIETARY_SUPPLEMENT

Extrinsic label 67Zn (ZnSO4) 0.2mg 70Zn added to the IV dose

Control wheat

Control wheat with low level of Zn

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Fortified wheat

Wheat fortified before consumption

Group Type ACTIVE_COMPARATOR

Fortified wheat

Intervention Type DIETARY_SUPPLEMENT

Extrinsic label 67Zn (ZnSO4) 0.2mg 70Zn added to the IV dose

Interventions

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Biofortified wheat

Extrinsic label 67Zn (ZnSO4) 0.2mg 70Zn added to the IV dose

Intervention Type DIETARY_SUPPLEMENT

Fortified wheat

Extrinsic label 67Zn (ZnSO4) 0.2mg 70Zn added to the IV dose

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Esperia

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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HarvestPlus

OTHER

Sponsor Role collaborator

Swiss Federal Institute of Technology

OTHER

Sponsor Role lead

Responsible Party

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Prof. Michael B. Zimmermann

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Diego Moretti, PhD

Role: PRINCIPAL_INVESTIGATOR

Swiss Federal Institute of Technology

References

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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.

Reference Type DERIVED
PMID: 31004128 (View on PubMed)

Other Identifiers

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KEK-ZH-2012-0483

Identifier Type: OTHER

Identifier Source: secondary_id

HNL/CTC_Zn_wheat

Identifier Type: -

Identifier Source: org_study_id

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