Does Sourdough Fermentation Improve Iron Uptake From Whole Grain Rye Bread?

NCT02462798 | Completed

• 1 other identifier: Chalmers0002
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Iron Bioavailability; Anaemia

Outcome Measures

Primary Outcomes (3)

• Serum ferritin

  12 week values corrected for baseline

• Serum transferrin receptor

  12 week values corrected for baseline

• Haemoglobin

  12 week values corrected for baseline

Study Arms (2)

Whole grain rye bread

PLACEBO COMPARATOR

Whole grain rye bread, 200 g/d. Control intervention.

Other: Whole grain rye bread

Whole grain sourdough rye bread

EXPERIMENTAL

Whole grain rye bread, 200 g/d. Experimental intervention.

Other: Whole grain sourdough rye bread

Interventions

Whole grain rye bread OTHER

Whole grain rye bread baked without sourdough fermentation (normal yeast-based fermentation)

Whole grain rye bread

Whole grain sourdough rye bread OTHER

Whole grain rye bread fermented with sourdough culture before baking

Whole grain sourdough rye bread

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy women under 50 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Chalmers University of Technology: lead
• Sahlgrenska University Hospital: collaborator

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2015
• First Posted: June 4, 2015
• Study Start: January 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: December 1, 2015
• Last Updated: March 15, 2018

Record last verified: 2018-03