Trial Summary
What is the purpose of this trial?This trial compares synthetic folic acid and natural 5-MTHF to see how they affect nutrient processing in healthy people. It uses special tracking methods to observe these changes and considers genetic differences in a key enzyme. 5-MTHF is a natural form of folate that is well absorbed and more bioavailable than synthetic folic acid, even in individuals with metabolic defects.
Eligibility Criteria
This trial is for generally healthy individuals with a BMI of 19-24 kg/m2 and normal levels of folate, vitamin B12, and B6. It's not for those who've used certain supplements recently, have chronic diseases like diabetes or asthma, are pregnant or breastfeeding, smoke, use drugs, drink heavily, can't swallow pills or consent in English.Inclusion Criteria
Body mass index of between 19-24 kg/m2
Normal folate, vitamin B12, and B6 status
Generally healthy
Exclusion Criteria
Blood donation in the last three months prior to study start
Use of vitamin supplements, amino acid or protein supplements for more than six months before study participation
Chronic consumption of a high-protein diet (e.g. Atkins Diet)
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Participant Groups
The study compares the effects of high-dose folic acid versus a natural form called 5-MTHF on DNA-related cellular mechanisms in humans. Researchers will track how these substances influence metabolic pathways using stable isotope tracer protocols.
2Treatment groups
Experimental Treatment
Group I: Folic acid supplementationExperimental Treatment1 Intervention
Folic acid will be given orally in form of tablets. A supplement of 1 mg will be taken daily for 12 weeks. Thereafter, a supplement of 5 mg will be taken daily for 12 weeks (i.e., until Week 24). At baseline, Week 12, and Week 24, subjects will receive a 9-hour primed constant infusion of amino acids in saline solution for quantification of kinetics of one-carbon metabolism.
Group II: 5-MTHF supplementationExperimental Treatment1 Intervention
The calcium salt of 5-methyltetrahydrofolate (5-MTHF; Brand name "Metafolin") will be given orally in form of tablets. A supplement of 1 mg will be taken daily for 12 weeks. Thereafter, a supplement of 5 mg will be taken daily for 12 weeks (i.e., until Week 24). At baseline, Week 12, and Week 24, subjects will receive a 9-hour primed constant infusion of amino acids in saline solution for quantification of kinetics of one-carbon metabolism.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Children's and Women's Health Centre of BC (incl. Sunny Hill), Child and Family Research InstituteVancouver, Canada
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Who Is Running the Clinical Trial?
University of British ColumbiaLead Sponsor