Modulating Early-life Nutrition for Childhood Obesity Prevention

NCT06091917 | Active Not Recruiting

• 1 other identifier: PIC-73-23
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant Growth; Childhood Overweight

Keywords

Betaine; infant formula; childhood obesity risk; infant growth; one-carbon metabolism

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Infant body composition

  At 12 months of follow-up

• Urine one-carbon metabolite concentration

  At 4 weeks and 12 weeks after start of treatment

Other Outcomes (1)

• Infant's DNA methylome

  At the end of the 12-week treatment

Study Arms (2)

Control group

SHAM COMPARATOR

Use of unmodified infant formula for 12 weeks

Dietary Supplement: Regular infant formula

Betaine supplementation group

EXPERIMENTAL

Use of infant formula supplemented with betaine (final concentration of 100 µmol/L) for 12 weeks

Dietary Supplement: Betaine supplementation in infant formula

Interventions

Betaine supplementation in infant formula DIETARY_SUPPLEMENT

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.

Betaine supplementation group

Regular infant formula DIETARY_SUPPLEMENT

Regular (unmodified) infant formula . The intervention will last for 12 weeks.

Control group

Eligibility Criteria

• Age: 0 Weeks - 4 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Presence of disease or malformations in the infant
• Infant birth weight \< -1 SD (standard deviations)
• Multiple pregnancy
• Elective c-section

Sponsors & Collaborators

• Fundació Sant Joan de Déu: lead

Study Sites (1)

Hospital Sant Joan de Déu

Barcelona, Barcelona, 08950, Spain

Location

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Infant Formula

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Milk Substitutes; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food, Formulated; Foods, Specialized; Food; Infant Food; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 19, 2023
• Study Start: October 31, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)