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Maternal Betaine Supplementation During Breastfeeding

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ClinicalTrials.gov Identifier: NCT04633044
Recruitment Status : Recruiting
First Posted : November 18, 2020
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
Fundació Sant Joan de Déu

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.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Dietary Supplement: Betaine Dietary Supplement: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Maternal Betaine Supplementation During Breastfeeding
Actual Study Start Date : February 11, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arm Intervention/treatment
Placebo Comparator: Placebo
400 mg of lactose daily for 12 weeks
Dietary Supplement: Placebo
The intervention with supplement will start during the first 48h after birth and will last for 12 weeks

Experimental: Supplement
400 mg of betaine daily for 12 weeks
Dietary Supplement: Betaine
The intervention with supplement will start during the first 48h after birth and will last for 12 weeks




Primary Outcome Measures :
  1. Change from birth weight-for-length z score at 1 month [ Time Frame: Birth and 1 month ]
    Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.

  2. Change from birth weight-for-length z score at 3 months [ Time Frame: Birth and 3 months ]
    Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.


Secondary Outcome Measures :
  1. Change from birth weight-for-length z score at 6 months [ Time Frame: Birth and 6 months ]
    Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.

  2. Change from birth weight-for-length z score at 12 months [ Time Frame: Birth and 12 months ]
    Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.

  3. Infant Body composition [ Time Frame: 3 and 12 months ]
    Total body and abdominal fat mass measured by DXA scan

  4. Breast milk concentration of betaine and related metabolites [ Time Frame: 1 and 3 months ]
    We will quantify betaine and related metabolites in maternal breast milk samples

  5. Maternal circulating concentration of betaine and related metabolites [ Time Frame: 1 and 3 months ]
    We will quantify betaine and related metabolites in maternal plasma samples

  6. Infant urine concentration of betaine and related metabolites [ Time Frame: 1, 3, and 6, and 12 months ]
    We will quantify betaine and related metabolites in infant urine samples

  7. Infant gut microbiome composition [ Time Frame: 1, 3, 6, and 12 months ]
    DNA from infant fecal samples will be sequenced to quantify abundance of the different bacterial groups.

  8. Maternal gut microbiome composition [ Time Frame: 1 and 3 months ]
    DNA from maternal fecal samples will be sequenced to quantify abundance of the different bacterial groups.


Other Outcome Measures:
  1. Breast milk microbiota composition [ Time Frame: 1 and 3 months ]
    DNA from breast milk samples will be sequenced to quantify abundance of the different bacterial groups.

  2. Breast milk metabolome [ Time Frame: 1 and 3 months ]
    Liquid chromatography coupled to mass spectrometry will be used to obtain a comprehensive metabolic profile of breast milk samples

  3. Child development (ASQ-3 questionnaire) [ Time Frame: 1, 3, 6, and 12 months ]
    Developmental progress will be evaluated with the parental reported ASQ-3 questionnaires



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Ages Eligible for Study:   20 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 weigth > -1 standard deviations
  • Absence of infant disease or malformations at birth

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04633044


Contacts
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Contact: Carles Lerin, PhD (+34) 93 600 97 51 clerin@fsjd.org

Locations
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Spain
Hospital Sant Joan de Deu Recruiting
Barcelona, Spain, 08950
Contact: Carles Lerin, PhD    (+34) 93 600 97 51    clerin@fsjd.org   
Contact: Marta Ramon Krauel, MD PhD    (+34) 93 280 40 00 ext 71263    mramonk@sjdhospitalbarcelona.org   
Sub-Investigator: Marta Ramon Krauel, MD PhD         
Principal Investigator: Carles Lerin, PhD         
Sponsors and Collaborators
Fundació Sant Joan de Déu
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Responsible Party: Fundació Sant Joan de Déu
ClinicalTrials.gov Identifier: NCT04633044    
Other Study ID Numbers: PIC-206-19
First Posted: November 18, 2020    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Body Weight
Betaine
Gastrointestinal Agents
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents