Clinical trial

Modulating Early-life Nutrition for Childhood Obesity Prevention

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT06091917

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age0 Weeks to 4 Weeks

SexAll

Healthy volunteersAccepted

ConditionInfant Growth, Childhood Overweight

Full registry criteria

Inclusion Criteria: * 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 Exclusion Criteria: * Presence of disease or malformations in the infant * Infant birth weight \< -1 SD (standard deviations) * Multiple pregnancy * Elective c-section

Treatments and study arms

Betaine supplementation in infant formula

Dietary Supplement

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

Dietary Supplement

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

Primary outcomes

Change in weight-for-length z scoreFrom 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 compositionAt 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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Hospital Sant Joan de Déu🇪🇸 Barcelona, Barcelona, Spain

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