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

March 19, 2026 updated by: Fundació Sant Joan de Déu
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Barcelona, Barcelona, Spain, 08950
        • Hospital Sant Joan de Déu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Control group
Use of unmodified infant formula for 12 weeks
Dietary supplement: Regular infant formula
Regular (unmodified) infant formula . The intervention will last for 12 weeks.
Experimental: Betaine supplementation group
Use of infant formula supplemented with betaine (final concentration of 100 µmol/L) for 12 weeks
Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From start to the end of treatment at 12 weeks and at 12 months of follow-up
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.
At 4 weeks and 12 weeks end of treatment, and at 12 months of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At 4 weeks and 12 weeks after start of treatment
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
At 12 months of follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the end of the 12-week treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Sant Joan de Déu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

October 13, 2023

First Submitted That Met QC Criteria

October 13, 2023

First Posted (Actual)

October 19, 2023

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIC-73-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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