Zinc Absorption in Flakes Derived from Sprouted or Hydrothermally Processed Wheat

Not Applicable

Completed

• Conditions: Zinc Absorption
• Interventions: Dietary Supplement: Processing of wheat

• Registration Number: NCT06236620
• Lead Sponsor: KU Leuven

Brief Summary

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

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 Timeline

• Study First Submitted: 2024-01-24
• Study First Submitted QC: 2024-01-24
• Study First Posted: 2024-02-01
• Study Start: 2024-02-19
• Primary Completion: 2024-07-02
• Study Completion: 2024-07-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control wheat flakes	Processing of wheat	Wheat flakes made of whole derived from unprocessed wheat
Flakes from sprouted wheat	Processing of wheat	Wheat flakes made of whole derived from sprouted wheat
Flakes from hydrothermally processed wheat	Processing of wheat	Wheat flakes made of whole derived from hydrothermally processed wheat

Primary Outcome Measures

Name	Time	Method
Zinc absorption	day 1 (before test meal) and day 5,6,7 and 8	Zinc isotope abundance in urine samples

Trial Locations

Locations (1)

KU Leuven/UZ Leuven; 🇧🇪 Leuven, Belgium