Iron and Zinc Absorption in Flakes Derived From Sprouted or Hydrothermally Processed Wheat

Iron Absorption Clinical Trial

— Wheatflakes  

Official title:

Iron and Zinc Absorption in Flakes Derived From Sprouted or Hydrothermally Processed Wheat

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06236620
• Other study ID #: S64419
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 19, 2024
• Est. completion date: October 1, 2024

Study information

• Verified date: January 2024
• Source: KU Leuven
• Contact: Kristin Verbeke, Prof.
• Phone: +3216330150
• Email: kristin.verbeke[@]kuleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

The study is divided into the iron and zinc study. The iron study is a randomised double-blind crossover design. 26 participants will consume the three test meal types (control wheat flakes, flakes derived from sprouted wheat and flakes derived from hydrothermally processed wheat) spiked with a specific iron isotope at three consecutive days as breakfast. The length of the study will be 17 days. The iron isotope composition in the blood of the participants will be measured on day 1 and day 17 of the 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: October 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Iron Absorption

Intervention

Dietary Supplement:
• Processing of wheat
Investigating if the consumption of sprouted or hydrothermally processed wheat affects the iron and zinc absorption in humans

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
KU Leuven

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Iron absorption	Iron isotope abundance in blood samples	day 1 (before test meal) and day 17
Primary	Zinc absorption	Zinc isotope abundance in urine samples	day 1 (before test meal) and day 5,6,7 and 8