Maternal Betaine Supplementation During Breastfeeding

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-11

Study Completion Date

2024-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

400 mg of lactose daily for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Supplement

400 mg of betaine daily for 12 weeks

Group Type EXPERIMENTAL

Betaine

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Betaine

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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