NutrOb: Modulating Early-life Nutrition for Childhood Obesity Prevention

Sponsor

Fundació Sant Joan de Déu (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06091917

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infant Growth Childhood Overweight	Dietary Supplement: Betaine supplementation in infant formula Dietary Supplement: Regular infant formula	N/A

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

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Modulating Early-life Nutrition for Childhood Obesity Prevention

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Control group Use of unmodified infant formula for 12 weeks	Dietary Supplement: Regular infant formula Regular (unmodified) infant formula . The intervention will last for 12 weeks.
Experimental: Betaine supplementation group Use of infant formula supplemented with betaine (final concentration of 100 µmol/L) for 12 weeks	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.

Arm

Intervention/Treatment

Sham Comparator: Control group

Use of unmodified infant formula for 12 weeks

Dietary Supplement: Regular infant formula

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

Experimental: Betaine supplementation group

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

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.

Outcome Measures

Primary Outcome Measures

Change in weight-for-length z score [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 [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 Outcome Measures

Infant body composition [At 12 months of follow-up]
Total body and abdominal fat mass measured by dual energy x-ray absorptiometry (DXA) scan
Urine one-carbon metabolite concentration [At 4 weeks and 12 weeks after start of treatment]
Urine samples will be analyzed to quantify betaine content as well as related metabolites (including dimethylglycine, the product of the betaine demethylation reaction

Other Outcome Measures

Infant's DNA methylome [At the end of the 12-week treatment]
DNA will be extracted from infant saliva samples. The DNA methylome will be obtained with array technology.