Maternal Betaine Supplementation During Breastfeeding

NCT04633044 | Active Not Recruiting Phase 1

• 1 other identifier: PIC-206-19
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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. An additional follow-up visit will be conducted at 48 months of age to repeat microbiome analysis, determine adiposity, and perform cognitive development assessment.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (2)

• Change from birth weight-for-length z score at 1 month

  Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.

  Birth and 1 month

• Change from birth weight-for-length z score at 3 months

  Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.

  Birth and 3 months

Secondary Outcomes (9)

• Change from birth weight-for-length z score at 6 months

  Birth and 6 months

• Change from birth weight-for-length z score at 12 months

  Birth and 12 months

• Change from birth weight-for-length z score at 48 months

  Birth and 48 months

• Infant Body composition

  3, 12 and 48 months

• Breast milk concentration of betaine and related metabolites

  1 and 3 months

Other Outcomes (7)

• Breast milk microbiota composition

  1 and 3 months

• Breast milk metabolome

  1 and 3 months

• Child development (ASQ-3 questionnaire)

  1, 3, 6, and 12 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

400 mg of lactose daily for 12 weeks

Dietary Supplement: Placebo

Supplement

EXPERIMENTAL

400 mg of betaine daily for 12 weeks

Dietary Supplement: Betaine

Interventions

Betaine DIETARY_SUPPLEMENT

The intervention with supplement will start during the first 48h after birth and will last for 12 weeks

Supplement

Placebo DIETARY_SUPPLEMENT

The intervention with supplement will start during the first 48h after birth and will last for 12 weeks

Placebo

Eligibility Criteria

• Age: 20 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Multiple pregnancy
• Lactose intolerance
• CBS deficiency (inherited disease)

Sponsors & Collaborators

• Fundació Sant Joan de Déu: lead

Study Sites (1)

Hospital Sant Joan de Deu

Barcelona, Barcelona, 08950, Spain

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Betaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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. An additional follow-up will be performed at 48 months of age.

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 18, 2020
• Study Start: February 11, 2021
• Primary Completion: December 31, 2023
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 24, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)