NCT06091917

Modulating Early-life Nutrition for Childhood Obesity Prevention

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Fundació Sant Joan de Déu · Academic / Other
• Sex: All
• Age: 0 Weeks – 4 Weeks
• Healthy volunteers: Accepted

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.

Conditions

• Infant Growth
• Childhood Overweight

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Betaine supplementation in infant formula	Infant formula will be supplemented with betaine to provide a final concentration of 100 µmol/L in the reconstituted milk. The intervention will last for 12 weeks.
DIETARY_SUPPLEMENT	Regular infant formula	Regular (unmodified) infant formula . The intervention will last for 12 weeks.

Timeline

• Start date: 2023-10-31
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2023-10-19
• Last updated: 2026-03-20

Locations

1 site across 1 country: Spain