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Modulating Early-life Nutrition for Childhood Obesity Prevention

NCT06091917 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-03-20

No results posted yet for this 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.

Conditions

  • Infant Growth
  • Childhood Overweight

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.

Sponsors & Collaborators

  • Fundació Sant Joan de Déu

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
0 Weeks
Max Age
4 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-31
Primary Completion
2026-06-30
Completion
2026-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06091917 on ClinicalTrials.gov