Maternal Betaine Supplementation During Breastfeeding

Overweight and Obesity Clinical Trial

— BetMilk  

Official title:

Maternal Betaine Supplementation During Breastfeeding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04633044
• Other study ID #: PIC-206-19
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 11, 2021
• Est. completion date: May 31, 2024

Study information

• Verified date: June 2024
• Source: Fundació Sant Joan de Déu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: May 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 42 Years

Eligibility

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)

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Dietary Supplement:
• Betaine
The intervention with supplement will start during the first 48h after birth and will last for 12 weeks
• Placebo
The intervention with supplement will start during the first 48h after birth and will last for 12 weeks

Locations

Country	Name	City	State
Spain	Hospital Sant Joan de Deu	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Sant Joan de Déu

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Breast milk microbiota composition	DNA from breast milk samples will be sequenced to quantify abundance of the different bacterial groups.	1 and 3 months
Other	Breast milk metabolome	Liquid chromatography coupled to mass spectrometry will be used to obtain a comprehensive metabolic profile of breast milk samples	1 and 3 months
Other	Child development (ASQ-3 questionnaire)	Developmental progress will be evaluated with the parental reported ASQ-3 questionnaires	1, 3, 6, and 12 months
Primary	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.	Birth and 1 month
Primary	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.	Birth and 3 months
Secondary	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.	Birth and 6 months
Secondary	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.	Birth and 12 months
Secondary	Infant Body composition	Total body and abdominal fat mass measured by DXA scan	3 and 12 months
Secondary	Breast milk concentration of betaine and related metabolites	We will quantify betaine and related metabolites in maternal breast milk samples	1 and 3 months
Secondary	Maternal circulating concentration of betaine and related metabolites	We will quantify betaine and related metabolites in maternal plasma samples	1 and 3 months
Secondary	Infant urine concentration of betaine and related metabolites	We will quantify betaine and related metabolites in infant urine samples	1, 3, and 6, and 12 months
Secondary	Infant gut microbiome composition	DNA from infant fecal samples will be sequenced to quantify abundance of the different bacterial groups.	1, 3, 6, and 12 months
Secondary	Maternal gut microbiome composition	DNA from maternal fecal samples will be sequenced to quantify abundance of the different bacterial groups.	1 and 3 months