Zinc Absorption in Flakes Derived from Sprouted or Hydrothermally Processed Wheat (Wheatflakes)

March 4, 2025 updated by: Kristin Verbeke, KU Leuven
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • KU Leuven/UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control wheat flakes
Wheat flakes made of whole derived from unprocessed wheat
Dietary supplement: Processing of wheat
Investigating if the consumption of sprouted or hydrothermally processed wheat affects the iron and zinc absorption in humans
Active Comparator: Flakes from sprouted wheat
Wheat flakes made of whole derived from sprouted wheat
Dietary supplement: Processing of wheat
Investigating if the consumption of sprouted or hydrothermally processed wheat affects the iron and zinc absorption in humans
Active Comparator: Flakes from hydrothermally processed wheat
Wheat flakes made of whole derived from hydrothermally processed wheat
Dietary supplement: Processing of wheat
Investigating if the consumption of sprouted or hydrothermally processed wheat affects the iron and zinc absorption in humans

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Zinc absorption
Time Frame: day 1 (before test meal) and day 5,6,7 and 8
Zinc isotope abundance in urine samples
day 1 (before test meal) and day 5,6,7 and 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Investigators

  • Principal Investigator: Kristin Verbeke, Prof., KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2024

Primary Completion (Actual)

July 2, 2024

Study Completion (Actual)

July 10, 2024

Study Registration Dates

First Submitted

January 24, 2024

First Submitted That Met QC Criteria

January 24, 2024

First Posted (Actual)

February 1, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 4, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • S64419

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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