Overweight and ObesityPhase 1/2BetMilkNCT04633044
Maternal Betaine Supplementation During Breastfeeding
A Phase 1/2 study testing Betaine in people with Overweight and Obesity, run by Fundació Sant Joan de Déu at 1 site in Spain.
Trial summary
Developing more efficient and cost-effective prevention strategies to slow down the worldwide epidemic of obesity and chronic metabolic disease has become a public health imperative. Read more about this study
- Who is it for?
- Ages 20 to 42 years, women only
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Betaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteSpain
- Study dates
- 11 Feb 2021to Oct 2026
- Phase
- Phase 1/2
- 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 20 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Multiple pregnancy
- Lactose intolerance
- CBS deficiency (inherited disease)
Trial locations and contacts
1 site in 1 country.
About this study
Developing more efficient and cost-effective prevention strategies to slow down the worldwide epidemic of obesity and chronic metabolic disease has become a public health imperative. Our previous results in humans demonstrate that lower breast milk betaine levels were associated with faster infant postnatal growth, a strong and potentially modifiable risk factor of future obesity. Betaine is a trimethylated derivative of glycine, which is present in multiple foods and occurs naturally in breast milk. In this study, we will perform a double-blind randomized placebo-controlled pilot clinical study, in which maternal diet will be supplemented with betaine for 3 months during breastfeeding; infant's growth and adiposity will be monitored until 12 months of age, and breast milk composition and gut microbiota analyzed. An additional follow-up visit will be conducted at 48 months of age to repeat microbiome analysis, determine adiposity, and perform cognitive development assessment.
- Conditions
- Overweight and Obesity
- Being tested
- Betaine, Placebo
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetaineDietary supplement
The intervention with supplement will start during the first 48h after birth and will last for 12 weeks
PlaceboDietary supplement
The intervention with supplement will start during the first 48h after birth and will last for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 400 mg of lactose daily for 12 weeks Receives: Dietary Supplement: Placebo |
| Supplement | Experimental | 400 mg of betaine daily for 12 weeks Receives: Dietary Supplement: Betaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from birth weight-for-length z score at 1 month
Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.
Measured: Birth and 1 month
Change from birth weight-for-length z score at 3 months
Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.
Measured: Birth and 3 months
Secondary outcomes (9)
Change from birth weight-for-length z score at 6 months
Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.
Measured: Birth and 6 months
Change from birth weight-for-length z score at 12 months
Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.
Measured: Birth and 12 months
Change from birth weight-for-length z score at 48 months
Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.
Measured: Birth and 48 months
Infant Body composition
Total body and abdominal fat mass measured by DXA scan
Measured: 3, 12 and 48 months
Breast milk concentration of betaine and related metabolites
We will quantify betaine and related metabolites in maternal breast milk samples
Measured: 1 and 3 months
Maternal circulating concentration of betaine and related metabolites
We will quantify betaine and related metabolites in maternal plasma samples
Measured: 1 and 3 months
Infant urine concentration of betaine and related metabolites
We will quantify betaine and related metabolites in infant urine samples
Measured: 1, 3, and 6, and 12 months
Infant gut microbiome composition
DNA from infant fecal samples will be sequenced to quantify abundance of the different bacterial groups.
Measured: 1, 3, 6, 12 and 48 months
Maternal gut microbiome composition
DNA from maternal fecal samples will be sequenced to quantify abundance of the different bacterial groups.
Measured: 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start11 Feb 2021
- Primary completion31 Dec 2023
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized placebo-controlled study with maternal dietary supplementation (betaine or placebo) for 3 months starting at infant birth and follow-up until 12 months of age. An additional follow-up will be performed at 48 months of age.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
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
- NCT04633044
- Sponsor's protocol ID
- PIC-206-19
- Acronym
- BetMilk
- Status last verified
- Sep 2025
- First submitted
- 9 Nov 2020
- Last updated
- 24 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 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Betaine Supplementation During Breastfeeding
- ClinicalTrials.gov ID
- NCT04633044
- Acronym / sponsor ID
- BetMilk / PIC-206-19
- Conditions
- Overweight and Obesity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- Oct 2026 (estimated)
- First posted
- 18 Nov 2020 (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.
Developing more efficient and cost-effective prevention strategies to slow down the worldwide epidemic of obesity and chronic metabolic disease has become a public health imperative. Our previous results in humans demonstrate that lower breast milk betaine levels were associated with faster infant postnatal growth, a strong and potentially modifiable risk factor of future obesity. Betaine is a trimethylated derivative of glycine, which is present in multiple foods and occurs naturally in breast milk. In this study, we will perform a double-blind randomized placebo-controlled pilot clinical study, in which maternal diet will be supplemented with betaine for 3 months during breastfeeding; infant's growth and adiposity will be monitored until 12 months of age, and breast milk composition and gut microbiota analyzed. An additional follow-up visit will be conducted at 48 months of age to repeat microbiome analysis, determine adiposity, and perform cognitive development assessment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized placebo-controlled study with maternal dietary supplementation (betaine or placebo) for 3 months starting at infant birth and follow-up until 12 months of age. An additional follow-up will be performed at 48 months of age.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo400 mg of lactose daily for 12 weeks |
| Supplement | Experimental | Dietary Supplement: Betaine400 mg of betaine daily for 12 weeks |
Who may qualify
- Ages
- 20 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Multiple pregnancy
- Lactose intolerance
- CBS deficiency (inherited disease)
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 |
|---|---|---|
| BetaineThe intervention with supplement will start during the first 48h after birth and will last for 12 weeks | Dietary supplement | Supplement |
| PlaceboThe intervention with supplement will start during the first 48h after birth and will last for 12 weeks | Dietary supplement | Placebo |
Primary outcome
Change from birth weight-for-length z score at 1 month
Time frame: Birth and 1 month
Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.
Change from birth weight-for-length z score at 3 months
Time frame: Birth and 3 months
Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.
9 secondary outcomes
Change from birth weight-for-length z score at 6 months
Time frame: Birth and 6 months
Change from birth weight-for-length z score at 12 months
Time frame: Birth and 12 months
Change from birth weight-for-length z score at 48 months
Time frame: Birth and 48 months
Infant Body composition
Time frame: 3, 12 and 48 months
Breast milk concentration of betaine and related metabolites
Time frame: 1 and 3 months
Maternal circulating concentration of betaine and related metabolites
Time frame: 1 and 3 months
Infant urine concentration of betaine and related metabolites
Time frame: 1, 3, and 6, and 12 months
Infant gut microbiome composition
Time frame: 1, 3, 6, 12 and 48 months
Maternal gut microbiome composition
Time frame: 1 and 3 months
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 24 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 Phase 1/2 study testing Betaine in people with Overweight and Obesity, 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 5 inclusion and 3 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 24 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 from birth weight-for-length z score at 1 month (time frame: Birth and 1 month). 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 24 Mar 2026.