Clinical Trials Logo
  1. Home
  2. Iron Absorption
  3. NCT06236620
  4. Details
NCT06236620 Clinical Trial

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
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
See also
  Status Clinical Trial Phase
Completed NCT03310203 - The Relation Between Adiposity, Inflammation, Glycaemia and Iron Absorption N/A
Completed NCT01493297 - Effects of Vitamin A and Carotenoids on Iron Absorption N/A
Active, not recruiting NCT02979132 - Iron Long-Term Labelling Study Switzerland N/A
Completed NCT03586245 - Iron Absorption From Iron Enriched Aspergillus Oryzae in Females Using Stable Isotope Methodology N/A
Completed NCT04774016 - Iron Absorption From an Iron-fortified Follow-up Formula With Added Synbiotic or Human Milk Oligosaccharides N/A
Active, not recruiting NCT02977806 - Iron Long-Term Labelling Study Malawi
Completed NCT02197624 - Genetic Variants and Iron Absorption N/A
Active, not recruiting NCT02979080 - Iron Long-Term Labelling Study Benin N/A
Recruiting NCT05973552 - Iron Absorption and Requirements in Pregnancy and Lactation
Completed NCT03894358 - Iron Absorption From a Wheat-based Instant Cereal:Gut and Stable Isotope Studies in Kenyan Infants N/A
Completed NCT01489007 - Iron Absorption in Vegetarian Children
Completed NCT05266703 - Defining the Serum Ferritin Concentration in Kenyan Women at Which the Body Senses Iron Depletion and Begins to Upregulate Iron Absorption N/A
Completed NCT02228902 - Iron Absorption Trial Phase 4
Completed NCT01483092 - Effect of Inulin on Iron Absorption in Humans N/A
Completed NCT01423162 - Iron Bioavailability of Fortified Oat Drink Phase 4
Completed NCT03453918 - Effects of Polyphenols on Iron Absorption in Iron Overload Disorders. N/A
Not yet recruiting NCT06327529 - Zinc and Iron Absorption From Common Beans in Young Adult Women N/A