Maternal Betaine Supplementation During Breastfeeding (BetMilk)

Fundació Sant Joan de Déu

Status and phase: Completed; Phase 2; Phase 1

Conditions: Overweight and Obesity

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Betaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04633044

PIC-206-19

Details and patient eligibility

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.

Enrollment: 47 patients

Sex: Female

Ages: 20 to 42 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

47 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

400 mg of lactose daily for 12 weeks

Treatment:

Dietary Supplement: Placebo

Supplement

Experimental group

Description:

400 mg of betaine daily for 12 weeks

Treatment:

Dietary Supplement: Betaine