Clinical trial

Maternal Betaine Supplementation During Breastfeeding

Active, not recruiting · Phase 1, Phase 2 · 1 countries · Registry ID NCT04633044

Active, not recruitingPhase 1, Phase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age20 Years to 42 Years

SexFemale

Healthy volunteersNot accepted

ConditionOverweight and Obesity

Full registry criteria

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)

Treatments and study arms

Betaine

Dietary Supplement

The intervention with supplement will start during the first 48h after birth and will last for 12 weeks

Placebo

Dietary Supplement

The intervention with supplement will start during the first 48h after birth and will last for 12 weeks

Primary outcomes

Change from birth weight-for-length z score at 1 monthBirth 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 monthsBirth and 3 months

Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Hospital Sant Joan de Deu🇪🇸 Barcelona, Barcelona, Spain

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