Bioavailability of Folic Acid Fortified Bread

Study Overview
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Brief Summary
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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.

Detailed Description
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See above.

Official Title
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Bioavailability of Folic Acid and L-5-methyltetrahydrofolic Acid in Fortified Bread: a Randomized Placebo-controlled Trial

Conditions
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Red Blood Cell Folate

Intervention / Treatment
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* Dietary Supplement: Folic acid
* Dietary Supplement: L-5-MTHF
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-45 years Not taking a folic acid containing supplement Exclusion Criteria: Adults who have medical conditions such as diabetes, asthma, cancer, cardiovascular disease, high blood pressure, celiac disease, or psychiatric illness Adults who are taking medications known to interfere with folate metabolism (i.e. phenytoin, sulphasalazine, methotrexate) Adults with wheat, milk allergy or lactose intolerance Adults with known B12 deficiency Adults who consume more than 1 alcoholic drink/day on average (1 drink=12 oz beer, 5 oz wine or 1.5 oz spirits) Women have been pregnant during the year previous Women planning a pregnancy in the next year Women who believe they may become pregnant during the study Women who have had a known previous neural tube defect affected pregnancy Adults who are unable to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Folic acid<br> | Dietary Supplement: Folic acid<br>* One roll/bun per day fortified with 400 µg of folic acid<br>|
| Experimental: L-5-MTHF<br> | Dietary Supplement: L-5-MTHF<br>* One roll/bun per day fortified with 452 µg of L-5-MTHF<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Placebo contains no folic acids<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| red blood cell folate concentration at three time points | 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. | baseline, 8th week, 16th week |