- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02462798
Does Sourdough Fermentation Improve Iron Uptake From Whole Grain Rye Bread?
March 14, 2018 updated by: Chalmers University of Technology
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
102
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 48 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Healthy women under 50 years old
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Whole grain rye bread
Whole grain rye bread, 200 g/d.
Control intervention.
|
Whole grain rye bread baked without sourdough fermentation (normal yeast-based fermentation)
|
Experimental: Whole grain sourdough rye bread
Whole grain rye bread, 200 g/d.
Experimental intervention.
|
Whole grain rye bread fermented with sourdough culture before baking
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum ferritin
Time Frame: 12 week values corrected for baseline
|
12 week values corrected for baseline
|
Serum transferrin receptor
Time Frame: 12 week values corrected for baseline
|
12 week values corrected for baseline
|
Haemoglobin
Time Frame: 12 week values corrected for baseline
|
12 week values corrected for baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
June 2, 2015
First Submitted That Met QC Criteria
June 3, 2015
First Posted (Estimate)
June 4, 2015
Study Record Updates
Last Update Posted (Actual)
March 15, 2018
Last Update Submitted That Met QC Criteria
March 14, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- Chalmers0002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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