Skip to main content
OpenTrials
Completed

NCT Number: NCT06236620

Zinc Absorption in Flakes Derived from Sprouted or Hydrothermally Processed Wheat

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KU Leuven/UZ Leuven

Leuven, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Processing of wheat

Dietary Supplement

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

Primary outcomes

  1. Zinc absorption

    Time frame: day 1 (before test meal) and day 5,6,7 and 8

    Zinc isotope abundance in urine samples

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Acronym: Wheatflakes

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 1, 2024
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.