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Maternal Betaine Supplementation During Breastfeeding
Sponsor: Fundació Sant Joan de Déu
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.
Key Details
Gender
FEMALE
Age Range
20 Years - 42 Years
Study Type
INTERVENTIONAL
Enrollment
47
Start Date
2021-02-11
Completion Date
2026-10
Last Updated
2026-03-24
Healthy Volunteers
No
Conditions
Interventions
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
Locations (1)
Hospital Sant Joan de Deu
Barcelona, Barcelona, Spain