Overweight and Obesity
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTBetaine
The intervention with supplement will start during the first 48h after birth and will last for 12 weeks
DIETARY_SUPPLEMENTPlacebo
The intervention with supplement will start during the first 48h after birth and will last for 12 weeks
Sponsors
Fundació Sant Joan de Déu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
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. An additional follow-up will be performed at 48 months of age.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 42 Years
Healthy volunteers
No
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 weight \> -1 standard deviations * Absence of infant disease or malformations at birth
Exclusion criteria
* Multiple pregnancy * Lactose intolerance * CBS deficiency (inherited disease)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from birth weight-for-length z score at 6 months | Birth and 6 months | 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 12 months | Birth and 12 months | 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 48 months | Birth and 48 months | Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores. |
| Infant Body composition | 3, 12 and 48 months | Total body and abdominal fat mass measured by DXA scan |
| Breast milk concentration of betaine and related metabolites | 1 and 3 months | We will quantify betaine and related metabolites in maternal breast milk samples |
| Maternal circulating concentration of betaine and related metabolites | 1 and 3 months | We will quantify betaine and related metabolites in maternal plasma samples |
| Infant urine concentration of betaine and related metabolites | 1, 3, and 6, and 12 months | We will quantify betaine and related metabolites in infant urine samples |
| Infant gut microbiome composition | 1, 3, 6, 12 and 48 months | DNA from infant fecal samples will be sequenced to quantify abundance of the different bacterial groups. |
| Maternal gut microbiome composition | 1 and 3 months | DNA from maternal fecal samples will be sequenced to quantify abundance of the different bacterial groups. |
Countries
Spain
Outcome results
None listed