This double-blind, randomized, placebo-controlled parallel trial evaluates the effects of maternal 5-methyltetrahydrofolate (5-MTHF) supplementation during breastfeeding. Thirty-six lactating mother-infant dyads will be randomized (1:1) to receive 5-MTHF or placebo for 6 weeks, stratified by infant sex and mode of delivery. Tolerability and adverse events will be monitored.
Pre- and post-intervention assessments include breast milk one-carbon metabolites and oligosaccharides; maternal plasma one-carbon metabolites and metabolic health markers. Maternal mental health will be evaluated using the SCL-90-R questionnaire. A follow-up visit at 4 months will reassess infant anthropometry and microbiome outcomes.
Maternal age between 18 and 42 years
Gestational age at birth ≥ 37 weeks.
Exclusive breastfeeding at enrollment.
Infant age 0-1 months
Multiple pregnancy
Presence of disease or malformations in the infant.
Weight-Standard Deviation Score < -1 at enrollment.
Use of folate-containing multivitamin supplements during breastfeeding
Parallel
5-MTHF Supplementation
Dietary supplementOral supplementation with 5-MTHF (800 µg) administered daily for 6 weeks during lactation.
Placebo
Other interventionMatching placebo administered daily for 6 weeks during lactation.
Incidence of Adverse Events
Treatment safety and tolerability will be evaluated by assessing differences in the incidence of potential adverse events between groups, focusing on gastrointestinal symptoms.
Change in breast milk 5-MTHF concentration
Change in breast milk 5-MTHF concentration measured with liquid chromatography coupled to mass spectrometry (LC-MS) from Baseline to 6 weeks.
Change in plasma 5-MTHF concentration
Change in maternal plasma 5-MTHF concentration measured with liquid chromatography coupled to mass spectrometry (LC-MS) from Baseline to 6 weeks.
Change in breast milk one-carbon metabolite concentration
Change in breast milk one-carbon-related metabolites (choline, methionine, SAM, SAH, homocysteine, cystathionine, folic acid, betaine) from Baseline to 6 weeks.
Change in plasma one-carbon metabolite concentration
Change in plasma one-carbon-related metabolites (choline, methionine, SAM, SAH, homocysteine, cystathionine, folic acid, betaine) from Baseline to 6 weeks.
Change in Human Milk Oligosaccharide (HMO) concentration
Change in HMO concentrations between Baseline and 6 weeks
Maternal and infant gut microbiome composition
Bacterial DNA will be isolated from infant and maternal fecal samples and sequenced to obtain microbiome composition.
Maternal plasma and breast milk metabolomic profile
The metabolomic profile will be obtained with the Biocrates Quant 1000 kit from plasma and breast milk samples.
Milk imprinted protein levels
Imprinted proteins in human milk samples will be analyzed by ELISA.
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