Modulating Early-life Nutrition for Childhood Obesity Prevention
- Conditions
- Childhood OverweightInfant Growth
- Interventions
- Dietary Supplement: Betaine supplementation in infant formulaDietary Supplement: Regular infant formula
- Registration Number
- NCT06091917
- Lead Sponsor
- Fundació Sant Joan de Déu
- Brief Summary
In this study, betaine intake will be increased in formula-fed infants through formula milk supplementation. To do this, a double-blind randomized study has been designed with the supplementation group (infant formula supplemented with betaine) and control group (unsupplemented infant formula). The main objectives of the study are to determine the safety of supplementation and to assess whether there are changes in infant growth.
- Detailed Description
Childhood obesity is one of the main public health concerns worldwide. Previous results have linked a nutrient called betaine (trimethylglycine) to the risk of childhood obesity. Betaine is a modified amino acid with osmotic properties that participates in the methionine cycle as a methyl group donor. Specifically, previous data demonstrate a link between breast milk betaine content, postnatal growth, and long-term metabolic health, suggesting that betaine supplementation may be an effective strategy for regulating growth trajectories and preventing childhood obesity. This study will assess the effects of increasing betaine intake in formula-fed infants through formula milk supplementation. To do this, a double-blind randomized study has been designed where participants will be randomly assigned to the control group or the supplementation group. The main objectives of the study are to determine the safety of supplementation and to assess whether there are changes in infant growth. Additionally, potential changes in the intestinal microbiome induced by the increase in betaine intake will be analyzed.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Maternal age between 17 and 42 years
- Maternal pre-pregnancy BMI equal or higher than 25
- Gestational age at birth > 37 weeks
- No exclusive breastfeeding at time of recruitment
- Presence of disease or malformations in the infant
- Infant birth weight < -1 SD (standard deviations)
- Multiple pregnancy
- Elective c-section
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Betaine supplementation group Betaine supplementation in infant formula Use of infant formula supplemented with betaine (final concentration of 100 µmol/L) for 12 weeks Control group Regular infant formula Use of unmodified infant formula for 12 weeks
- Primary Outcome Measures
Name Time Method Change in weight-for-length z score From start to the end of treatment at 12 weeks and at 12 months of follow-up Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.
Changes in fecal microbiota composition At 4 weeks and 12 weeks end of treatment, and at 12 months of follow-up Differences in features associated with a healthy mucosal layer and metabolic state (e.g. Bifidobacteria and Akkermansia relative amount). Stool samples will be processed to isolate the bacterial DNA. Microbiome composition will be determined by DNA sequencing.
- Secondary Outcome Measures
Name Time Method Urine one-carbon metabolite concentration At 4 weeks and 12 weeks after start of treatment Urine samples will be analyzed to quantify betaine content as well as related metabolites (including dimethylglycine, the product of the betaine demethylation reaction
Infant body composition At 12 months of follow-up Total body and abdominal fat mass measured by dual energy x-ray absorptiometry (DXA) scan
Trial Locations
- Locations (1)
Hospital Sant Joan de Déu
🇪🇸Barcelona, Spain