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Breastfeeding boost: betaine supplement may curb baby obesity risk

NCT ID NCT04633044

Prevention Sponsor: Fundació Sant Joan de Déu Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving breastfeeding mothers a natural nutrient called betaine can help prevent rapid weight gain in babies, which is linked to later obesity. About 47 mothers with overweight or obesity will take betaine or a placebo for 3 months while exclusively breastfeeding. Researchers will track the babies' growth, body fat, and gut health until age 4.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

47 people

The number who actually took part.

Started

Feb 2021

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 42 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Maternal Pre-pregnancy BMI between 25 and 40. * Willing to exclusively breastfeed for ≥ 3 months * Infant gestational age at birth \> 37 weeks * Infant birth weight \> -1 standard deviations * Absence of infant disease or malformations at birth Exclusion Criteria: * Multiple pregnancy * Lactose intolerance * CBS deficiency (inherited disease)

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Conditions

The condition(s) this trial relates to.

Obesity Overweight obesity disorder prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Overweight and obesity

Contacts and locations

Locations

  • Hospital Sant Joan de Deu

    Barcelona, Barcelona, 08950, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.