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

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.

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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