Infant GrowthNutrObNCT06091917
Modulating Early-life Nutrition for Childhood Obesity Prevention
A study testing Betaine supplementation in infant formula and Regular infant formula in people with Infant Growth and Childhood Overweight, run by Fundació Sant Joan de Déu at 1 site in Spain.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 0 to 4 weeksHealthy volunteers can take part
- Conditions the study is for
- Infant Growth, Childhood Overweight
- What is being tested?
- Betaine supplementation in infant formula and Regular infant formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 31 Oct 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 4 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Presence of disease or malformations in the infant
- Infant birth weight < -1 SD (standard deviations)
- Multiple pregnancy
- Elective c-section
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Infant Growth, Childhood Overweight
- Being tested
- Betaine supplementation in infant formula, Regular infant formula
- Keywords
- Betaine, infant formula, childhood obesity risk, infant growth, one-carbon metabolism
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Betaine supplementation in infant formulaDietary 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 formulaDietary supplement
Regular (unmodified) infant formula . The intervention will last for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | Use of unmodified infant formula for 12 weeks Receives: Dietary Supplement: Regular infant formula |
| Betaine supplementation group | Experimental | Use of infant formula supplemented with betaine (final concentration of 100 µmol/L) for 12 weeks Receives: Dietary Supplement: Betaine supplementation in infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight-for-length z score
Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.
Measured: From start to the end of treatment at 12 weeks and at 12 months of follow-up
Changes in fecal microbiota composition
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.
Measured: At 4 weeks and 12 weeks end of treatment, and at 12 months of follow-up
Secondary outcomes (2)
Infant body composition
Total body and abdominal fat mass measured by dual energy x-ray absorptiometry (DXA) scan
Measured: At 12 months of follow-up
Urine one-carbon metabolite concentration
Urine samples will be analyzed to quantify betaine content as well as related metabolites (including dimethylglycine, the product of the betaine demethylation reaction
Measured: At 4 weeks and 12 weeks after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start31 Oct 2023
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant GrowthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091917
- Sponsor's protocol ID
- PIC-73-23
- Acronym
- NutrOb
- Status last verified
- Mar 2026
- First submitted
- 13 Oct 2023
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulating Early-life Nutrition for Childhood Obesity Prevention
- ClinicalTrials.gov ID
- NCT06091917
- Acronym / sponsor ID
- NutrOb / PIC-73-23
- Conditions
- Infant Growth, Childhood Overweight
- Keywords
- Betaine, infant formula, childhood obesity risk, infant growth, one-carbon metabolism
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Dietary Supplement: Regular infant formulaUse of unmodified infant formula for 12 weeks |
| Betaine supplementation group | Experimental | Dietary Supplement: Betaine supplementation in infant formulaUse of infant formula supplemented with betaine (final concentration of 100 µmol/L) for 12 weeks |
Who may qualify
- Ages
- 0 to 4 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Presence of disease or malformations in the infant
- Infant birth weight < -1 SD (standard deviations)
- Multiple pregnancy
- Elective c-section
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Betaine supplementation in infant formulaInfant 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. | Dietary supplement | Betaine supplementation group |
| Regular infant formulaRegular (unmodified) infant formula . The intervention will last for 12 weeks. | Dietary supplement | Control group |
Primary outcome
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.
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.
2 secondary outcomes
Infant body composition
Time frame: At 12 months of follow-up
Urine one-carbon metabolite concentration
Time frame: At 4 weeks and 12 weeks after start of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Betaine supplementation in infant formula and Regular infant formula in people with Infant Growth and Childhood Overweight, run by Fundació Sant Joan de Déu at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.