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OpenTrials
Active, Not Recruiting

NCT Number: NCT06091917

Modulating Early-life Nutrition for Childhood Obesity Prevention

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Infant Growth Body Weight Childhood Overweight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

0 week–4 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Sant Joan de Déu

Barcelona, 08950, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Betaine supplementation in infant formula

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.

Regular infant formula

Dietary Supplement

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

Primary outcomes

  1. Change in weight-for-length z score

    Time frame: From start to the end of treatment at 12 weeks and at 12 months of follow-up

    Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.

  2. Changes in fecal microbiota composition

    Time frame: At 4 weeks and 12 weeks end of treatment, and at 12 months of follow-up

    Differences in features associated with a healthy mucosal layer and metabolic state (e.g. Bifidobacteria and Akkermansia relative amount). Stool samples will be processed to isolate the bacterial DNA. Microbiome composition will be determined by DNA sequencing.

Secondary outcomes

  1. Infant body composition

    Time frame: At 12 months of follow-up

    Total body and abdominal fat mass measured by dual energy x-ray absorptiometry (DXA) scan

  2. Urine one-carbon metabolite concentration

    Time frame: At 4 weeks and 12 weeks after start of treatment

    Urine samples will be analyzed to quantify betaine content as well as related metabolites (including dimethylglycine, the product of the betaine demethylation reaction

Other outcomes

  1. Infant's DNA methylome

    Time frame: At the end of the 12-week treatment

    DNA will be extracted from infant saliva samples. The DNA methylome will be obtained with array technology.

Sponsors and collaborators

Lead sponsor

Fundació Sant Joan de Déu

Other

Registry information

Acronym: NutrOb

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 19, 2023
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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