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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02462798
Other study ID # Chalmers0002
Secondary ID
Status Completed
Phase N/A
First received June 2, 2015
Last updated March 14, 2018
Start date January 2010
Est. completion date December 2015

Study information

Verified date March 2018
Source Chalmers University of Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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


Recruitment information / eligibility

Status Completed
Enrollment 102
Est. completion date December 2015
Est. primary completion date July 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Whole grain rye bread
Whole grain rye bread baked without sourdough fermentation (normal yeast-based fermentation)
Whole grain sourdough rye bread
Whole grain rye bread fermented with sourdough culture before baking

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Chalmers University of Technology Sahlgrenska University Hospital, Sweden

Outcome

Type Measure Description Time frame Safety issue
Primary Serum ferritin 12 week values corrected for baseline
Primary Serum transferrin receptor 12 week values corrected for baseline
Primary Haemoglobin 12 week values corrected for baseline
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