Modulating Early-life Nutrition for Childhood Obesity Prevention
Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Maximum Age: 28 days
Healthy Volunteers: t
View:
• 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
Locations
Other Locations
Spain
Hospital Sant Joan de Déu
RECRUITING
Barcelona
Contact Information
Primary
Carles Lerin, PhD
carles.lerin@sjd.es
(+34) 93600 9751
Backup
Marta Ramon Krauel, MD PhD
marta.ramon@sjd.es
(+34) 932804000
Time Frame
Start Date: 2023-10-31
Estimated Completion Date: 2025-12
Participants
Target number of participants: 50
Treatments
Sham_comparator: Control group
Use of unmodified infant formula for 12 weeks
Experimental: Betaine supplementation group
Use of infant formula supplemented with betaine (final concentration of 100 µmol/L) for 12 weeks
Related Therapeutic Areas
Sponsors
Leads: Fundació Sant Joan de Déu