Modulating Early-life Nutrition for Childhood Obesity Prevention (NutrOb)

Fundació Sant Joan de Déu

Status: Enrolling

Conditions: Infant Growth; Childhood Overweight

Treatments: Dietary Supplement: Regular infant formula; Dietary Supplement: Betaine supplementation in infant formula

Study type: Interventional

Funder types: Other

Identifiers

NCT06091917

PIC-73-23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: Under 4 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

Control group

Sham Comparator group

Description:

Use of unmodified infant formula for 12 weeks

Treatment:

Dietary Supplement: Regular infant formula

Betaine supplementation group

Experimental group

Description:

Use of infant formula supplemented with betaine (final concentration of 100 µmol/L) for 12 weeks

Treatment:

Dietary Supplement: Betaine supplementation in infant formula