HealthyNCT05536947
Micronutrient Bioavailability From Wheat
A study testing Bread product (standard milled), Bread Product (micro-milled) and Bread Product (standard aleurone) in people with Healthy, run by King's College London at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine if physical disruption of wheat aleurone cell walls (micro-milling) increases micronutrient availability. Read more about this study
- Who is it for?
- Ages 19 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Bread product (standard milled), Bread Product (micro-milled) and Bread Product (standard aleurone)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Nov 2021to Dec 2022
- 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 19 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy pre-menopausal women
- Serum ferritin below 30 μg/L
- Plasma zinc below 13.8 μmol/L.
Who cannot join
- Allergic to gluten or wheat
- Pregnant
- Post-menopausal women
- History of alcohol or substance abuse
- History of Cardiovascular Disease, diabetes, cancer, kidney, liver or intestinal disease, gastrointestinal disorder or use of drugs likely to alter gastrointestinal function.
- Donated blood recently (within 3 months prior to screening visit)
- Volunteers planning to take any mineral or vitamin supplements during the course of the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College London
London
Mohamad Farshard C Aslam, PhD, 02078484331, micronutrient@kcl.ac.uk
Paul A Sharp, PhD
About this study
The purpose of this study is to determine if physical disruption of wheat aleurone cell walls (micro-milling) increases micronutrient availability.
Read the detailed description
This research project is a short-term dietary intervention study to investigate the bio-availability of iron and zinc from wheat. Approximately 50% of iron and 30% of zinc in the United Kingdom diet is provided by cereals and cereal products (e.g. bread and breakfast cereals). The localisation of both iron and zinc metals in wheat is largely confined to the aleurone layer, a single layer of cells located between the centre (endosperm) and outer layers (testa and pericarp). The aleurone layer is removed during the production of white flour. For this reason, since 1953 it has been mandatory to add iron to flours at the mill to restore iron to levels present in wholegrain flour (The Bread and Flour Regulations, 1998).
The investigators have shown that aleurone cells are resistant to physical disruption and digestion as they pass along the gastrointestinal tract and are excreted intact in faeces. The investigators believe that disruption of wheat aleurone cell walls prior to food manufacturing would therefore increase iron and zinc availability. Using wholegrain flour and purified wheat aleurone flour the investigators have shown that micro-milling, a process which reduces particle size of flour from approximately 100μm to 10μm, ruptures the aleurone cell walls, and increases iron availability, i.e. the amount absorbed by intestinal cells, compared with flour produced using standard milling techniques (which does not break down the aleurone layer).
Based on these initial findings, the current study therefore has 2 main aims:
(i) to determine whether physical disruption of the aleurone (by micro-milling) in wholegrain flour increases iron and zinc availability from wholegrain bread.
(ii) to determine whether addition of micro-milled aleurone flour to white flour increases iron availability from white bread.
- Conditions
- Healthy
- Being tested
- Bread product (standard milled), Bread Product (micro-milled), Bread Product (standard aleurone), Bread product (micro-milled aleurone)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bread product (standard milled)Other
Bread rolls made from standard milled flour.
Bread Product (micro-milled)Other
Bread rolls made from micro-milled whole grain flour.
Bread Product (standard aleurone)Other
Bread rolls made from white flour/standard milled aleurone mix
Bread product (micro-milled aleurone)Other
Bread rolls made from white flour/micro-milled aleurone mix.
| Study group | Role | What they receive |
|---|---|---|
| Standard-milled Wholegrain | Active comparator | Bread rolls prepared using standard-milled Wholegrain (75 g per bread roll, containing stable isotopes of Fe and Zn), with butter and strawberry jam. Receives: Other: Bread product (standard milled) |
| Micro-milled Wholegrain | Experimental | Bread rolls prepared using Micro-milled Wholegrain (75 g per bread roll, containing stable isotopes of Fe and Zn), with butter and strawberry jam. Receives: Other: Bread Product (micro-milled) |
| White flour fortified with standard milled Aleurone | Active comparator | Bread rolls prepared using a white flour and standard-milled aleurone mix (75 g per bread roll, containing stable isotope of Fe), with butter and strawberry jam. Receives: Other: Bread Product (standard aleurone) |
| White flour fortified with micro-milled Aleurone | Experimental | Bread rolls prepared using a white flour and micro-milled aleurone mix (75 g per bread roll, containing stable isotope of Fe), with butter and strawberry jam. Receives: Other: Bread product (micro-milled aleurone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of 57-Fe incorporation into erythrocytes
Determines Fe incorporation from test meal into Red Blood Cells
Measured: Through study completion, an average of 1 year
Urinary excretion of Zinc
Determine excretion of Zinc in urine samples to assess Zinc bioavailability
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Analysis of iron status biomarkers from blood samples
Determine Hepcidin concentration from sample
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start26 Nov 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul A Sharp, PhD, Principal investigator, King's College London, Department of Nutritional Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536947
- Sponsor's protocol ID
- HR-18/19-5718
- Status last verified
- Nov 2021
- First submitted
- 14 Dec 2021
- Last updated
- 13 Sep 2022
- 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 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micronutrient Bioavailability From Wheat
- ClinicalTrials.gov ID
- NCT05536947
- Acronym / sponsor ID
- HR-18/19-5718
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 26 Nov 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 13 Sep 2022 (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 purpose of this study is to determine if physical disruption of wheat aleurone cell walls (micro-milling) increases micronutrient availability.
Detailed description
This research project is a short-term dietary intervention study to investigate the bio-availability of iron and zinc from wheat. Approximately 50% of iron and 30% of zinc in the United Kingdom diet is provided by cereals and cereal products (e.g. bread and breakfast cereals). The localisation of both iron and zinc metals in wheat is largely confined to the aleurone layer, a single layer of cells located between the centre (endosperm) and outer layers (testa and pericarp). The aleurone layer is removed during the production of white flour. For this reason, since 1953 it has been mandatory to add iron to flours at the mill to restore iron to levels present in wholegrain flour (The Bread and Flour Regulations, 1998).
The investigators have shown that aleurone cells are resistant to physical disruption and digestion as they pass along the gastrointestinal tract and are excreted intact in faeces. The investigators believe that disruption of wheat aleurone cell walls prior to food manufacturing would therefore increase iron and zinc availability. Using wholegrain flour and purified wheat aleurone flour the investigators have shown that micro-milling, a process which reduces particle size of flour from approximately 100μm to 10μm, ruptures the aleurone cell walls, and increases iron availability, i.e. the amount absorbed by intestinal cells, compared with flour produced using standard milling techniques (which does not break down the aleurone layer).
Based on these initial findings, the current study therefore has 2 main aims:
(i) to determine whether physical disruption of the aleurone (by micro-milling) in wholegrain flour increases iron and zinc availability from wholegrain bread.
(ii) to determine whether addition of micro-milled aleurone flour to white flour increases iron availability from white bread.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard-milled Wholegrain | Active comparator | Other: Bread product (standard milled)Bread rolls prepared using standard-milled Wholegrain (75 g per bread roll, containing stable isotopes of Fe and Zn), with butter and strawberry jam. |
| Micro-milled Wholegrain | Experimental | Other: Bread Product (micro-milled)Bread rolls prepared using Micro-milled Wholegrain (75 g per bread roll, containing stable isotopes of Fe and Zn), with butter and strawberry jam. |
| White flour fortified with standard milled Aleurone | Active comparator | Other: Bread Product (standard aleurone)Bread rolls prepared using a white flour and standard-milled aleurone mix (75 g per bread roll, containing stable isotope of Fe), with butter and strawberry jam. |
| White flour fortified with micro-milled Aleurone | Experimental | Other: Bread product (micro-milled aleurone)Bread rolls prepared using a white flour and micro-milled aleurone mix (75 g per bread roll, containing stable isotope of Fe), with butter and strawberry jam. |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy pre-menopausal women
- Serum ferritin below 30 μg/L
- Plasma zinc below 13.8 μmol/L.
Key exclusion criteria (7 listed)
- Allergic to gluten or wheat
- Pregnant
- Post-menopausal women
- History of alcohol or substance abuse
- History of Cardiovascular Disease, diabetes, cancer, kidney, liver or intestinal disease, gastrointestinal disorder or use of drugs likely to alter gastrointestinal function.
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 |
|---|---|---|
| Bread product (standard milled)Bread rolls made from standard milled flour. | Other | Standard-milled Wholegrain |
| Bread Product (micro-milled)Bread rolls made from micro-milled whole grain flour. | Other | Micro-milled Wholegrain |
| Bread Product (standard aleurone)Bread rolls made from white flour/standard milled aleurone mix | Other | White flour fortified with standard milled Aleurone |
| Bread product (micro-milled aleurone)Bread rolls made from white flour/micro-milled aleurone mix. | Other | White flour fortified with micro-milled Aleurone |
Primary outcome
Analysis of 57-Fe incorporation into erythrocytes
Time frame: Through study completion, an average of 1 year
Determines Fe incorporation from test meal into Red Blood Cells
Urinary excretion of Zinc
Time frame: Through study completion, an average of 1 year
Determine excretion of Zinc in urine samples to assess Zinc bioavailability
1 secondary outcome
Analysis of iron status biomarkers from blood samples
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Paul A Sharp, PhD principal investigator
King's College London, Department of Nutritional Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bread product (standard milled), Bread Product (micro-milled) and Bread Product (standard aleurone) in people with Healthy, run by King's College London at 1 site in United Kingdom.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 13 Sep 2022. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamad F Aslam, PhD (020 7836 5454, micronutrient@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of 57-Fe incorporation into erythrocytes (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 13 Sep 2022.