Modulating Early-life Nutrition for Childhood Obesity Prevention
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Fundació Sant Joan de Déu
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change in weight-for-length z score
Overview
Brief Summary
In this study, betaine intake will be increased in formula-fed infants through formula milk supplementation. To do this, a double-blind randomized study has been designed with the supplementation group (infant formula supplemented with betaine) and control group (unsupplemented infant formula). The main objectives of the study are to determine the safety of supplementation and to assess whether there are changes in infant growth.
Detailed Description
Childhood obesity is one of the main public health concerns worldwide. Previous results have linked a nutrient called betaine (trimethylglycine) to the risk of childhood obesity. Betaine is a modified amino acid with osmotic properties that participates in the methionine cycle as a methyl group donor. Specifically, previous data demonstrate a link between breast milk betaine content, postnatal growth, and long-term metabolic health, suggesting that betaine supplementation may be an effective strategy for regulating growth trajectories and preventing childhood obesity. This study will assess the effects of increasing betaine intake in formula-fed infants through formula milk supplementation. To do this, a double-blind randomized study has been designed where participants will be randomly assigned to the control group or the supplementation group. The main objectives of the study are to determine the safety of supplementation and to assess whether there are changes in infant growth. Additionally, potential changes in the intestinal microbiome induced by the increase in betaine intake will be analyzed.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 0 Weeks to 4 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Maternal age between 17 and 42 years
- •Maternal pre-pregnancy BMI equal or higher than 25
- •Gestational age at birth \> 37 weeks
- •No exclusive breastfeeding at time of recruitment
Exclusion Criteria
- •Presence of disease or malformations in the infant
- •Infant birth weight \< -1 SD (standard deviations)
- •Multiple pregnancy
- •Elective c-section
Outcomes
Primary Outcomes
Change in weight-for-length z score
Time Frame: From start to the end of treatment at 12 weeks and at 12 months of follow-up
Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.
Changes in fecal microbiota composition
Time Frame: At 4 weeks and 12 weeks end of treatment, and at 12 months of follow-up
Differences in features associated with a healthy mucosal layer and metabolic state (e.g. Bifidobacteria and Akkermansia relative amount). Stool samples will be processed to isolate the bacterial DNA. Microbiome composition will be determined by DNA sequencing.
Secondary Outcomes
- Urine one-carbon metabolite concentration(At 4 weeks and 12 weeks after start of treatment)
- Infant body composition(At 12 months of follow-up)