Zinc Absorption in Flakes Derived from Sprouted or Hydrothermally Processed Wheat

NCT06236620 | Completed

• 1 other identifier: S64419
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Zinc Absorption

Keywords

zinc absorption; zinc bio-availability

Outcome Measures

Primary Outcomes (1)

• Zinc absorption

  Zinc isotope abundance in urine samples

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

Study Arms (3)

Control wheat flakes

ACTIVE COMPARATOR

Wheat flakes made of whole derived from unprocessed wheat

Dietary Supplement: Processing of wheat

Flakes from sprouted wheat

ACTIVE COMPARATOR

Wheat flakes made of whole derived from sprouted wheat

Dietary Supplement: Processing of wheat

Flakes from hydrothermally processed wheat

ACTIVE COMPARATOR

Wheat flakes made of whole derived from hydrothermally processed wheat

Dietary Supplement: Processing of wheat

Interventions

Processing of wheat DIETARY_SUPPLEMENT

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

Control wheat flakes; Flakes from hydrothermally processed wheat; Flakes from sprouted wheat

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

KU Leuven/UZ Leuven

Leuven, 3000, Belgium

Location

Study Officials

• Kristin Verbeke, Prof.

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 1, 2024
• Study Start: February 19, 2024
• Primary Completion: July 2, 2024
• Study Completion: July 10, 2024
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)