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

NCT Number	NCT04633044
Lead Sponsor	Fundació Sant Joan de Déu
Conditions	Overweight and Obesity
Enrollment	47 participants
Start Date	2021-02-11
Primary Completion	2023-12-31 (estimated)
Study Completion	2026-10 (estimated)
Updated on ClinicalTrials.gov	2026-03-24