Clinical trial NCT06091917: Modulating Early-life Nutrition for Childhood Obesity Prevention
Official title: Modulating Early-life Nutrition for Childhood Obesity Prevention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infant Growth
Childhood Overweight
Keywords: Betaine
infant formula
childhood obesity risk
infant growth
one-carbon metabolism
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 50
Sex: ALL
Minimum age (years): 0
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: Childhood obesity is one of the main public health concerns worldwide. Previous results have linked a nutrient called betaine (trimethylglycine) to the risk of childhood obesity. Betaine is a modified amino acid with osmotic properties that participates in the methionine cycle as a methyl group donor. Specifically, previous data demonstrate a link between breast milk betaine content, postnatal growth, and long-term metabolic health, suggesting that betaine supplementation may be an effective strategy for regulating growth trajectories and preventing childhood obesity. This study will assess the effects of increasing betaine intake in formula-fed infants through formula milk supplementation. To do this, a double-blind randomized study has been designed where participants will be randomly assigned to the control group or the supplementation group. The main objectives of the study are to determine the safety of supplementation and to assess whether there are changes in infant growth. Additionally, potential changes in the intestinal microbiome induced by the increase in betaine intake will be analyzed.

Eligibility 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

Primary outcomes:
measure: Change in weight-for-length z score
timeFrame: From start to the end of treatment at 12 weeks and at 12 months of follow-up
measure: Changes in fecal microbiota composition
timeFrame: At 4 weeks and 12 weeks end of treatment, and at 12 months of follow-up
Secondary outcomes:
measure: Infant body composition
timeFrame: At 12 months of follow-up
measure: Urine one-carbon metabolite concentration
timeFrame: At 4 weeks and 12 weeks after start of treatment
Other outcomes:
measure: Infant's DNA methylome
timeFrame: At the end of the 12-week treatment
Locations:
city: Barcelona
country: Spain
facility: Hospital Sant Joan de Déu
Study officials:
References: