Iron BioavailabilityNCT02462798
Does Sourdough Fermentation Improve Iron Uptake From Whole Grain Rye Bread?
A study testing Whole grain rye bread and Whole grain sourdough rye bread in people with Iron Bioavailability and Anaemia, run by Chalmers University of Technology.
Trial summary
Iron deficiency anaemia is a major problem for women worldwide. Cereal foods are a major source of iron, but much of this is not bioavailability due to it being bound by the high amounts of phytate present in cereals. Destruction of phytate by the phytase enzyme can release iron and increase its bioavailability. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Bioavailability, Anaemia
- What is being tested?
- Whole grain rye bread and Whole grain sourdough rye bread
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Dec 2015
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women under 50 years old
Who cannot join
- Pregnancy or breast feeding
- Use of mineral or other dietary supplements
- Use of medical or recreational drugs
- Donation of blood within the previous 3 months
About this study
Iron deficiency anaemia is a major problem for women worldwide. Cereal foods are a major source of iron, but much of this is not bioavailability due to it being bound by the high amounts of phytate present in cereals. Destruction of phytate by the phytase enzyme can release iron and increase its bioavailability. In a human cell model of iron uptake, sourdough fermentation, which included activation of phytase, the enzyme that breaks down phyate, led to improved iron bioavailability. This clinical trial will attempt to demonstrate that this concept also works in humans
- Conditions
- Iron Bioavailability, Anaemia
- Being tested
- Whole grain rye bread, Whole grain sourdough rye bread
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole grain rye breadOther
Whole grain rye bread baked without sourdough fermentation (normal yeast-based fermentation)
Whole grain sourdough rye breadOther
Whole grain rye bread fermented with sourdough culture before baking
| Study group | Role | What they receive |
|---|---|---|
| Whole grain rye bread | Placebo comparator | Whole grain rye bread, 200 g/d. Control intervention. Receives: Other: Whole grain rye bread |
| Whole grain sourdough rye bread | Experimental | Whole grain rye bread, 200 g/d. Experimental intervention. Receives: Other: Whole grain sourdough rye bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum ferritin
Measured: 12 week values corrected for baseline
Serum transferrin receptor
Measured: 12 week values corrected for baseline
Haemoglobin
Measured: 12 week values corrected for baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startJan 2010
- Primary completionJul 2013
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron BioavailabilityStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chalmers University of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462798
- Sponsor's protocol ID
- Chalmers0002
- Status last verified
- Mar 2018
- First submitted
- 2 Jun 2015
- Last updated
- 15 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Sourdough Fermentation Improve Iron Uptake From Whole Grain Rye Bread?
- ClinicalTrials.gov ID
- NCT02462798
- Acronym / sponsor ID
- Chalmers0002
- Conditions
- Iron Bioavailability, Anaemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Chalmers University of TechnologyUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital
- Study start
- Jan 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Jun 2015 (estimated)
- 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.
Iron deficiency anaemia is a major problem for women worldwide. Cereal foods are a major source of iron, but much of this is not bioavailability due to it being bound by the high amounts of phytate present in cereals. Destruction of phytate by the phytase enzyme can release iron and increase its bioavailability. In a human cell model of iron uptake, sourdough fermentation, which included activation of phytase, the enzyme that breaks down phyate, led to improved iron bioavailability. This clinical trial will attempt to demonstrate that this concept also works in humans
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole grain rye bread | Placebo comparator | Other: Whole grain rye breadWhole grain rye bread, 200 g/d. Control intervention. |
| Whole grain sourdough rye bread | Experimental | Other: Whole grain sourdough rye breadWhole grain rye bread, 200 g/d. Experimental intervention. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy women under 50 years old
Key exclusion criteria (4 listed)
- Pregnancy or breast feeding
- Use of mineral or other dietary supplements
- Use of medical or recreational drugs
- Donation of blood within the previous 3 months
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 |
|---|---|---|
| Whole grain rye breadWhole grain rye bread baked without sourdough fermentation (normal yeast-based fermentation) | Other | Whole grain rye bread |
| Whole grain sourdough rye breadWhole grain rye bread fermented with sourdough culture before baking | Other | Whole grain sourdough rye bread |
Primary outcome
Serum ferritin
Time frame: 12 week values corrected for baseline
Serum transferrin receptor
Time frame: 12 week values corrected for baseline
Haemoglobin
Time frame: 12 week values corrected for baseline
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 15 Mar 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Whole grain rye bread and Whole grain sourdough rye bread in people with Iron Bioavailability and Anaemia, run by Chalmers University of Technology.
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 1 inclusion and 4 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 15 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Serum ferritin (time frame: 12 week values corrected for baseline). The study lists 3 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 15 Mar 2018.