Zinc Absorption in Flakes Derived from Sprouted or Hydrothermally Processed Wheat

NCT ID: NCT06236620

Last Updated: 2025-03-07

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

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-19

Study Completion Date

2024-07-10

Brief Summary

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The aim of this project is to investigate whether the increased zinc bio-accessibility values in sprouted or hydrothermally processed wheat is reflected in an increased zinc absorption in human subjects after consuming breakfast flakes derived from such processed wheats.

Detailed Description

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The zinc study is a randomised crossover design with two different meals (control wheat flakes and flakes derived from sprouted wheat or flakes derived from hydrothermally processed wheat) spiked with a specific zinc isotope. The study contains two test groups (I and II) of 26 and 10 participants, respectively. Both test groups will consume the control wheat flakes, whereas test group I will consume the flakes from sprouted wheat and group II the flakes from hydrothermally processed wheat randomised over two test days. An intravenous dose of Zn will be given on day 1 of the study and the zinc isotope composition in the urine of the participants will be measured on day 1,5,6,7 and 8 of the study.

Conditions

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Zinc Absorption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control wheat flakes

Wheat flakes made of whole derived from unprocessed wheat

Group Type ACTIVE_COMPARATOR

Processing of wheat

Intervention Type DIETARY_SUPPLEMENT

Investigating if the consumption of sprouted or hydrothermally processed wheat affects the iron and zinc absorption in humans

Flakes from sprouted wheat

Wheat flakes made of whole derived from sprouted wheat

Group Type ACTIVE_COMPARATOR

Processing of wheat

Intervention Type DIETARY_SUPPLEMENT

Investigating if the consumption of sprouted or hydrothermally processed wheat affects the iron and zinc absorption in humans

Flakes from hydrothermally processed wheat

Wheat flakes made of whole derived from hydrothermally processed wheat

Group Type ACTIVE_COMPARATOR

Processing of wheat

Intervention Type DIETARY_SUPPLEMENT

Investigating if the consumption of sprouted or hydrothermally processed wheat affects the iron and zinc absorption in humans

Interventions

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Processing of wheat

Investigating if the consumption of sprouted or hydrothermally processed wheat affects the iron and zinc absorption in humans

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* BMI range 18.5-25.0 kg/m²
* Regular diet with 3 meals a day (at least 5 times a week)

Exclusion Criteria

* Intake of vitamin and/or mineral supplements during and 2 weeks before the stud
* Intake of antibiotics 3 months prior to the study
* Intake of medicines that have an impact on the gastrointestinal tract during and 2 weeks before the study
* Previous or current gastrointestinal (e.g. Crohn's disease), endocrine or eating disorders or other gastrointestinal history
* Previous or current substance/alcohol dependence or abuse (\> 2 units per day/14 units per week)
* Currently smoking (have smoked in the last 28 days) or willingness to smoke during the study period
* Pregnant or lactating or wishing to become pregnant in the period of the study
* Allergy or intolerance to wheat (coeliac disease, gluten sensitivity) or citric acid
* Adherence to vegan or vegetarian diets or special diets (weight loss, gluten-free etc…)
* Blood donation in the 6 months prior to the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Kristin Verbeke

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristin Verbeke, Prof.

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

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KU Leuven/UZ Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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S64419

Identifier Type: -

Identifier Source: org_study_id

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