Modulating Early-life Nutrition for Childhood Obesity Prevention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-31

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Infant Growth Childhood Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control group

Use of unmodified infant formula for 12 weeks

Group Type SHAM_COMPARATOR

Regular infant formula

Intervention Type DIETARY_SUPPLEMENT

Regular (unmodified) infant formula . The intervention will last for 12 weeks.

Betaine supplementation group

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

Group Type EXPERIMENTAL

Betaine supplementation in infant formula

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Regular infant formula

Regular (unmodified) infant formula . The intervention will last for 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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