One-carbon Metabolism in Healthy Individuals Clinical Trial
Official title:
Metabolic Consequences of High-Dose Folic Acid Supplementation on Kinetics of 1-Carbon Metabolism
Periconceptional supplementation with folic acid - the synthetic form of the B-vitamin folate - reduces the occurrence of adverse pregnancy outcomes such as spina bifida. The underlying biochemical mechanisms for how folic acid affects health outcomes however are unknown. The naturally occurring form 5-methyltetrahydrofolate (5-MTHF) is now available and discussed as an adequate substitute to folic acid. This study aims to determine the effect of folic acid compared to 5-MTHF on cellular mechanisms. Stable isotope tracer protocols will be used that allow determining the effect of folic acid on the dynamics of metabolic pathways in the human body. Hypothesis: Supplementation with high-dose folic acid alters the turnover rate of folate dependent pathways in healthy humans; but 5-MTHF does not. Genetic variations in a key enzyme of the folate metabolism will aggravate the effect of folic acid on the metabolic pathways.
| Status | Not yet recruiting |
| Enrollment | 25 |
| Est. completion date | December 31, 2026 |
| Est. primary completion date | December 31, 2026 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 20 Years to 35 Years |
| Eligibility | Inclusion Criteria: - Generally healthy - Body mass index of between 19-24 kg/m2 - Normal folate, vitamin B12, and B6 status Exclusion Criteria: - Unable to swallow tablets - Unable to receive intravenous catheters - 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) - Medical conditions such as diabetes, asthma, cancer, cardiovascular disease, a history of neural tube defect (such as spina bifida) affected pregnancy, have had gastrointestinal surgery, abnormal kidney, thyroid function, or psychiatric illness, or any other chronic disease - Pregnancy or lactation - Smoking, use of recreational drugs, and/or consumption of more than one alcohol drink per day or more than seven per week. - Use of long-term prescription medication such as hormonal contraceptives, antidepressants, anticonvulsants, anticoagulants, or other chronic medication - Blood donation in the last three months prior to study start - Unable to provide informed consent, or unable to read and write English - Low compliance to intervention as determined by early steady-state or reduction in blood folate concentrations |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Children's and Women's Health Centre of BC (incl. Sunny Hill), Child and Family Research Institute | Vancouver | British Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| University of British Columbia |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Plateau enrichment of infused amino acid tracers and related metabolites to quantify turnover rates of folate dependent pathways | 24 weeks |