Clinical trial NCT04633044: Maternal Betaine Supplementation During Breastfeeding
Official title: Maternal Betaine Supplementation During Breastfeeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Overweight and Obesity
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
First posted: 2020-11-18
Enrollment: 47
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized placebo-controlled study with maternal dietary supplementation (betaine or placebo) for 3 months starting at infant birth and follow-up until 12 months of age.
Primary purpose: PREVENTION

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.


Eligibility 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)

Primary outcomes:
measure: Change from birth weight-for-length z score at 1 month
timeFrame: Birth and 1 month
measure: Change from birth weight-for-length z score at 3 months
timeFrame: Birth and 3 months
Secondary outcomes:
measure: Change from birth weight-for-length z score at 6 months
timeFrame: Birth and 6 months
measure: Change from birth weight-for-length z score at 12 months
timeFrame: Birth and 12 months
measure: Infant Body composition
timeFrame: 3 and 12 months
measure: Breast milk concentration of betaine and related metabolites
timeFrame: 1 and 3 months
measure: Maternal circulating concentration of betaine and related metabolites
timeFrame: 1 and 3 months
measure: Infant urine concentration of betaine and related metabolites
timeFrame: 1, 3, and 6, and 12 months
measure: Infant gut microbiome composition
timeFrame: 1, 3, 6, and 12 months
measure: Maternal gut microbiome composition
timeFrame: 1 and 3 months
Other outcomes:
measure: Breast milk microbiota composition
timeFrame: 1 and 3 months
measure: Breast milk metabolome
timeFrame: 1 and 3 months
measure: Child development (ASQ-3 questionnaire)
timeFrame: 1, 3, 6, and 12 months
Locations:
city: Barcelona
country: Spain
facility: Hospital Sant Joan de Deu
Study officials:
References: