Zinc AbsorptionWheatflakesNCT06236620
Zinc Absorption in Flakes Derived from Sprouted or Hydrothermally Processed Wheat
A study testing Processing of wheat in people with Zinc Absorption, run by KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Zinc Absorption
- What is being tested?
- Processing of wheat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Feb 2024to 10 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI range 18.5-25.0 kg/m²
- Regular diet with 3 meals a day (at least 5 times a week)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Zinc Absorption
- Being tested
- Processing of wheat
- Keywords
- zinc absorption, zinc bio-availability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Processing of wheatDietary supplement
Investigating if the consumption of sprouted or hydrothermally processed wheat affects the iron and zinc absorption in humans
| Study group | Role | What they receive |
|---|---|---|
| Control wheat flakes | Active comparator | Wheat flakes made of whole derived from unprocessed wheat Receives: Dietary Supplement: Processing of wheat |
| Flakes from sprouted wheat | Active comparator | Wheat flakes made of whole derived from sprouted wheat Receives: Dietary Supplement: Processing of wheat |
| Flakes from hydrothermally processed wheat | Active comparator | Wheat flakes made of whole derived from hydrothermally processed wheat Receives: Dietary Supplement: Processing of wheat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Zinc absorption
Zinc isotope abundance in urine samples
Measured: day 1 (before test meal) and day 5,6,7 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start19 Feb 2024
- Primary completion2 Jul 2024
- Study completion10 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Zinc AbsorptionStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Verbeke, KU Leuven
- Investigators
- Kristin Verbeke, Prof., Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236620
- Sponsor's protocol ID
- S64419
- Acronym
- Wheatflakes
- Status last verified
- Mar 2025
- First submitted
- 24 Jan 2024
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zinc Absorption in Flakes Derived from Sprouted or Hydrothermally Processed Wheat
- ClinicalTrials.gov ID
- NCT06236620
- Acronym / sponsor ID
- Wheatflakes / S64419
- Conditions
- Zinc Absorption
- Keywords
- zinc absorption, zinc bio-availability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 2 Jul 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control wheat flakes | Active comparator | Dietary Supplement: Processing of wheatWheat flakes made of whole derived from unprocessed wheat |
| Flakes from sprouted wheat | Active comparator | Dietary Supplement: Processing of wheatWheat flakes made of whole derived from sprouted wheat |
| Flakes from hydrothermally processed wheat | Active comparator | Dietary Supplement: Processing of wheatWheat flakes made of whole derived from hydrothermally processed wheat |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI range 18.5-25.0 kg/m²
- Regular diet with 3 meals a day (at least 5 times a week)
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Processing of wheatInvestigating if the consumption of sprouted or hydrothermally processed wheat affects the iron and zinc absorption in humans | Dietary supplement | Control wheat flakes, Flakes from hydrothermally processed wheat, Flakes from sprouted wheat |
Primary outcome
Zinc absorption
Time frame: day 1 (before test meal) and day 5,6,7 and 8
Zinc isotope abundance in urine samples
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Zinc Absorption
Recruiting
Zinc and Iron Absorption From Common Beans in Young Adult Women
Zinc Absorption, Iron Absorption
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin Verbeke, Prof. principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Processing of wheat in people with Zinc Absorption, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Zinc absorption (time frame: day 1 (before test meal) and day 5,6,7 and 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.