Maternal Betaine Supplementation During Breastfeeding

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

Study summary

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. An additional follow-up visit will be conducted at 48 months of age to repeat microbiome analysis, determine adiposity, and perform cognitive development assessment.

Eligibility

Primary outcome measure(s)

• Change from birth weight-for-length z score at 1 month — Birth and 1 month
  Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.
• Change from birth weight-for-length z score at 3 months — Birth and 3 months
  Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.

Trial sites (1)

More Fundació Sant Joan de Déu trials in Spain

Other trials for the same condition