Modulating Early-life Nutrition for Childhood Obesity Prevention

Infant Growth Clinical Trial

— NutrOb  

Official title:

Modulating Early-life Nutrition for Childhood Obesity Prevention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06091917
• Other study ID #: PIC-73-23
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2023
• Est. completion date: December 2025

Study information

• Verified date: June 2024
• Source: Fundació Sant Joan de Déu
• Contact: Carles Lerin, PhD
• Phone: (+34) 93600 9751
• Email: carles.lerin[@]sjd.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Weeks to 4 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Childhood Overweight
• Infant Growth
• Obesity
• Overweight
• Pediatric Obesity

Intervention

Dietary Supplement:
• Betaine supplementation in infant formula
Infant formula will be supplemented with betaine to provide a final concentration of 100 µmol/L in the reconstituted milk. The intervention will last for 12 weeks.
• Regular infant formula
Regular (unmodified) infant formula . The intervention will last for 12 weeks.

Locations

Country	Name	City	State
Spain	Hospital Sant Joan de Déu	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Sant Joan de Déu

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Infant's DNA methylome	DNA will be extracted from infant saliva samples. The DNA methylome will be obtained with array technology.	At the end of the 12-week treatment
Primary	Change in weight-for-length z score	Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.	From start to the end of treatment at 12 weeks and at 12 months of follow-up
Primary	Changes in fecal microbiota composition	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.	At 4 weeks and 12 weeks end of treatment, and at 12 months of follow-up
Secondary	Infant body composition	Total body and abdominal fat mass measured by dual energy x-ray absorptiometry (DXA) scan	At 12 months of follow-up
Secondary	Urine one-carbon metabolite concentration	Urine samples will be analyzed to quantify betaine content as well as related metabolites (including dimethylglycine, the product of the betaine demethylation reaction	At 4 weeks and 12 weeks after start of treatment