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ACTIVE NOT RECRUITING
NCT06091917
NA

Modulating Early-life Nutrition for Childhood Obesity Prevention

Sponsor: Fundació Sant Joan de Déu

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

0 Weeks - 4 Weeks

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2023-10-31

Completion Date

2026-12

Last Updated

2026-03-20

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

Hospital Sant Joan de Déu

Barcelona, Barcelona, Spain