Maternal Betaine Supplementation During Breastfeeding

Developing more efficient and cost-effective prevention strategies to slow down the worldwide epidemic of obesity and chronic metabolic disease has become a public health imperative. Our previous results in humans demonstrate that lower breast milk betaine levels were associated with faster infant postnatal growth, a strong and potentially modifiable risk factor of future obesity. Betaine is a trimethylated derivative of glycine, which is present in multiple foods and occurs naturally in breast milk. In this study, we will perform a double-blind randomized placebo-controlled pilot clinical study, in which maternal diet will be supplemented with betaine for 3 months during breastfeeding; infant's growth and adiposity will be monitored until 12 months of age, and breast milk composition and gut microbiota analyzed.

Randomized placebo-controlled study with maternal dietary supplementation (betaine or placebo) for 3 months starting at infant birth and follow-up until 12 months of age.

The intervention with supplement will start during the first 48h after birth and will last for 12 weeks

The intervention with supplement will start during the first 48h after birth and will last for 12 weeks

Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.

Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.

Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.

Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.

DNA from infant fecal samples will be sequenced to quantify abundance of the different bacterial groups.

DNA from maternal fecal samples will be sequenced to quantify abundance of the different bacterial groups.

DNA from breast milk samples will be sequenced to quantify abundance of the different bacterial groups.

Liquid chromatography coupled to mass spectrometry will be used to obtain a comprehensive metabolic profile of breast milk samples

Inclusion Criteria: Maternal Pre-pregnancy BMI between 25 and 40. Willing to exclusively breastfeed for ≥ 3 months Infant gestational age at birth > 37 weeks Infant birth weigth > -1 standard deviations Absence of infant disease or malformations at birth Exclusion Criteria: Multiple pregnancy Lactose intolerance CBS deficiency (inherited disease)