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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5-MTHF Supplementation | Experimental | Dietary Supplement (5-MTHF) |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-MTHF Supplementation | Dietary Supplement | Oral supplementation with 5-MTHF (800 µg) administered daily for 6 weeks during lactation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6 weeks, 4 months |
| 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. | Baseline, 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6 weeks |
| Change in breast milk one-carbon metabolite concentration |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal and infant gut microbiome composition | Bacterial DNA will be isolated from infant and maternal fecal samples and sequenced to obtain microbiome composition. | Baseline, 6 weeks |
| Maternal plasma and breast milk metabolomic profile |
Inclusion Criteria:
Exclusion Criteria:
Female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carles Lerin, PhD | Contact | (+34) 93 600 97 51 | carles.lerin@sjd.es | |
| Marta Ramon Krauel, MD PhD | Contact | (+34) 93 280 40 00 | Ext. 71263 | marta.ramon@sjd.es |
| Name | Affiliation | Role |
|---|---|---|
| Carles Lerin, PhD | Fundació Sant Joan de Déu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Sant Joan de Deu | Barcelona | Barcelona | 08950 | Spain |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| Placebo | Other | Matching placebo administered daily for 6 weeks during lactation. |
|
Change in breast milk one-carbon-related metabolites (choline, methionine, SAM, SAH, homocysteine, cystathionine, folic acid, betaine) from Baseline to 6 weeks. |
| Baseline, 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. | Baseline, 6 weeks |
| Change in Human Milk Oligosaccharide (HMO) concentration | Change in HMO concentrations between Baseline and 6 weeks | Baseline, 6 weeks |
| Change in Maternal Plasma Glucose Concentration | Change in maternal blood glucose levels between baseline and 6 weeks. | Baseline, 6 weeks |
| Change in Maternal Plasma Glycated Hemoglobin (HbA1c) Concentration | Change in maternal blood glycated hemoglobin (HbA1c) between baseline and 6 weeks. | Baseline, 6 weeks |
| Change in Maternal Plasma Insulin Concentration | Change in maternal blood insulin levels between Baseline and 6 weeks. | Baseline, 6 weeks |
| Change in Maternal Plasma Triglyceride (TAG) Concentration | Change in maternal blood triglyceride (TAG) levels between baseline and 6 weeks. | Baseline, 6 weeks |
| Change in Maternal Blood Total Cholesterol Concentration | Change in maternal blood total Cholesterol levels between baseline and 6 weeks. | Baseline, 6 weeks |
| Change in Maternal Blood LDL Cholesterol Concentration | Change in maternal low-density lipoprotein (LDL) cholesterol levels between baseline and 6 weeks. | Baseline, 6 weeks |
| Change in Maternal Blood HDL Cholesterol Concentration | Change in maternal high-density lipoprotein (HDL) cholesterol levels between baseline and 6 weeks. | Baseline, 6 weeks |
| Change in Maternal Blood Alanine Aminotransferase (ALT) Levels | Change in maternal alanine aminotransferase (ALT) levels between baseline and 6 weeks. | Baseline, 6 weeks |
| Change in Maternal Blood Aspartate Aminotransferase (AST) Levels | Change in maternal aspartate aminotransferase (AST) levels between baseline and 6 weeks. | Baseline, 6 weeks |
| Change in Maternal Blood Gamma-Glutamyl Transferase (GGT) Levels | Change in maternal gamma-glutamyl transferase (GGT) levels between baseline and 6 weeks. | Baseline, 6 weeks |
| Change in Symptom Checklist-90-Revised (SCL-90-R) scale | The SCL-90-R is a 90-item self-report questionnaire assessing psychological symptoms over the past week, with a range of 0-90 across 9 dimenions: Somatization, Obsessive-compulsive, Interpersonal sensitivity, Depression, Anxiety, Hostility, Phobic anxiety, Paranoid ideation, Psychoticism. Higher scores indicate worse outcome. | Baseline, 3 weeks |
| Change in infant BMI z-score | We will measure infant body weight, length, and head circumference to calculate BMI z-scores according to WHO growth standards, and changes between baseline, 6 weeks and 4 months will be assessed. | Baseline, 6 weeks |
The metabolomic profile will be obtained with the Biocrates Quant 1000 kit from plasma and breast milk samples.
| Baselina, 6 weeks |
| Milk imprinted protein levels | Imprinted proteins in human milk samples will be analyzed by ELISA. | Baseline, 6 weeks |
| Hospital Sant Joan de Déu | Barcelona | Barcelona | 08950 | Spain |
|