NCT04633044

Maternal Betaine Supplementation During Breastfeeding

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Fundació Sant Joan de Déu · Academic / Other
• Sex: Female
• Age: 20 Years – 42 Years
• Healthy volunteers: Not accepted

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. 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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Betaine	The intervention with supplement will start during the first 48h after birth and will last for 12 weeks
DIETARY_SUPPLEMENT	Placebo	The intervention with supplement will start during the first 48h after birth and will last for 12 weeks

Timeline

• Start date: 2021-02-11
• Primary completion: 2023-12-31
• Completion: 2026-10-01
• First posted: 2020-11-18
• Last updated: 2026-03-24

Locations

1 site across 1 country: Spain