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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
47
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
Hospital Sant Joan de Deu
Barcelona, Spain
Change from birth weight-for-length z score at 1 month
Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.
Time frame: Birth and 1 month
Change from birth weight-for-length z score at 3 months
Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.
Time frame: Birth and 3 months
Change from birth weight-for-length z score at 6 months
Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.
Time frame: Birth and 6 months
Change from birth weight-for-length z score at 12 months
Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.
Time frame: Birth and 12 months
Infant Body composition
Total body and abdominal fat mass measured by DXA scan
Time frame: 3 and 12 months
Breast milk concentration of betaine and related metabolites
We will quantify betaine and related metabolites in maternal breast milk samples
Time frame: 1 and 3 months
Maternal circulating concentration of betaine and related metabolites
We will quantify betaine and related metabolites in maternal plasma samples
Time frame: 1 and 3 months
Infant urine concentration of betaine and related metabolites
We will quantify betaine and related metabolites in infant urine samples
Time frame: 1, 3, and 6, and 12 months
Infant gut microbiome composition
DNA from infant fecal samples will be sequenced to quantify abundance of the different bacterial groups.
Time frame: 1, 3, 6, and 12 months
Maternal gut microbiome composition
DNA from maternal fecal samples will be sequenced to quantify abundance of the different bacterial groups.
Time frame: 1 and 3 months
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