Maternal Betaine Supplementation During Breastfeeding

Phase 1

Completed

• Conditions: Overweight and Obesity
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Betaine

• Registration Number: NCT04633044
• Lead Sponsor: Fundació Sant Joan de Déu

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-09
• Study First Submitted QC: 2020-11-16
• Study First Posted: 2020-11-18
• Study Start: 2021-02-11
• Primary Completion: 2023-12-31
• Study Completion: 2024-05-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-04
• Last Update Posted: 2024-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 47

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	400 mg of lactose daily for 12 weeks
Supplement	Betaine	400 mg of betaine daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change from birth weight-for-length z score at 1 month	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	Birth and 3 months	Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.

Secondary Outcome Measures

Name	Time	Method
Change from birth weight-for-length z score at 6 months	Birth and 6 months	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 12 months	Birth and 12 months	Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.
Infant Body composition	3 and 12 months	Total body and abdominal fat mass measured by DXA scan
Infant gut microbiome composition	1, 3, 6, and 12 months	DNA from infant fecal samples will be sequenced to quantify abundance of the different bacterial groups.
Maternal gut microbiome composition	1 and 3 months	DNA from maternal fecal samples will be sequenced to quantify abundance of the different bacterial groups.
Maternal circulating concentration of betaine and related metabolites	1 and 3 months	We will quantify betaine and related metabolites in maternal plasma samples
Breast milk concentration of betaine and related metabolites	1 and 3 months	We will quantify betaine and related metabolites in maternal breast milk samples
Infant urine concentration of betaine and related metabolites	1, 3, and 6, and 12 months	We will quantify betaine and related metabolites in infant urine samples

Trial Locations

Locations (1)

Hospital Sant Joan de Deu; 🇪🇸 Barcelona, Spain