Modulating Early-life Nutrition for Childhood Obesity Prevention

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Regular infant formula: Regular (unmodified) infant formula . The intervention will last for 12 weeks.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)

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