Increasing betaine in infant formula to prevent childhood obesity
Modulating Early-life Nutrition for Childhood Obesity Prevention
This study tests if adding betaine to infant formula can help prevent childhood obesity by looking at how it affects growth and gut health in babies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 0 Weeks to 4 Weeks |
| Sex | All |
| Sponsor | Fundació Sant Joan de Déu Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT06091917 on ClinicalTrials.gov |
What this trial studies
This study aims to increase betaine intake in formula-fed infants by supplementing their formula with this nutrient. It is a double-blind randomized trial where infants will be assigned to either a betaine-supplemented formula group or a control group receiving regular formula. The primary goals are to evaluate the safety of the supplementation and to observe any changes in infant growth patterns. Additionally, the study will investigate potential alterations in the intestinal microbiome resulting from increased betaine intake.
Who should consider this trial
Good fit: Ideal candidates for this study are formula-fed infants born to mothers aged 17 to 42 years with a pre-pregnancy BMI of 25 or higher.
Not a fit: Patients who may not benefit from this study include infants with diseases or malformations, low birth weight, or those born from multiple pregnancies.
Why it matters
Potential benefit: If successful, this approach could help regulate growth trajectories in infants and reduce the risk of childhood obesity.
How similar studies have performed: While the approach of using betaine supplementation is relatively novel, previous studies have suggested a link between betaine in breast milk and improved metabolic health, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Barcelona
- Hospital Sant Joan de Déu — Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Carles Lerin, PhD
- Email: carles.lerin@sjd.es
- Phone: (+34) 93600 9751
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.