Bioavailability of Folic Acid Fortified Bread
Folic acid is the synthetic form of vitamin folate. Because of its high stability and bioavailability, it is the form of folate added to bread in Canada to reduce birth defects. There are health concerns about long-term folic acid consumption. Another form of folate, L-5-methyltetrahydrofolic acid (L-5-MTHF) has become available which does not have these health concerns. Unfortunately L-5-MTHF is not as stable as folic acid, but the investigators have developed a method to stabilize L-5-MTHF in food. The investigators plan to conduct a randomized trial to compare the bioavailability of bread fortified with L-5-MTHF versus folic acid.
The investigators hypothesize that bread fortified with L-5-MTHF will increase red cell folate over 16 weeks to the same extent as bread fortified with equimolar folic acid.
|Red Blood Cell Folate||Dietary Supplement: Folic acid Dietary Supplement: L-5-MTHF Other: Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
|Official Title:||Bioavailability of Folic Acid and L-5-methyltetrahydrofolic Acid in Fortified Bread: a Randomized Placebo-controlled Trial|
- red blood cell folate concentration at three time points [ Time Frame: baseline, 8th week, 16th week ]We will take one blood sample at baseline, 8th and 16th week. For each blood sample, we will measure the red blood cell folate concentration as our primary outcome measure. We will record the changes in the folate concentrations.
|Study Start Date:||April 2012|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: Folic acid||
Dietary Supplement: Folic acid
One roll/bun per day fortified with 400 µg of folic acid
Dietary Supplement: L-5-MTHF
One roll/bun per day fortified with 452 µg of L-5-MTHF
|Placebo Comparator: Placebo||
Placebo contains no folic acids
Please refer to this study by its ClinicalTrials.gov identifier: NCT01570088
|Canada, British Columbia|
|University of British Columbia|
|Vancouver, British Columbia, Canada, V6T 1Z4|
|Principal Investigator:||Tim Green, PhD||University of British Columbia|