Breastmilk and the Link to Overweight/Obesity and Maternal Diet in the Mother-breastmilk-child Triad

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age19+
SponsorWarsaw University of Life Sciences

About this trial

The prospective 5-month follow-up study will involve 150 mother-infant dyads grouped based on maternal baseline BMI category (normal weight, overweight, obesity). The investigators plan 3 study visits (1, 3, and 6 months postpartum) with analysis the following parameters and outcomes:

1. maternal anthropometry and body composition; 2. maternal dietary intake and dietary patterns (with results of biomarker-based validation); 3. maternal status of lipophilic antioxidants, selected vitamins, and fatty acids profile that may be related to adipose tissue metabolism, inflammation, and cardiometabolic status; 4. maternal metabolomics, adipokines, insulin, selected biomarkers of inflammation, altered glucose metabolism, and oxidation; 5. breastmilk composition assessed by systemic approach (macronutrients, fatty acids profile, lipophilic antioxidants, adipokines, hormones, immunological profile, and preliminary lipidomic analysis in part of the study group); 6. infant growth trajectory, body composition, urine metabolomics, and biomarkers of oxidative stress.

Additionally, maternal and infant stool, buccal swabs, and human milk samples will be banked for further microbiome analysis studies.

Eligibility criteria

Qualifiers

at least 19 years,

plan of exclusively or predominantly breastfeeding for 6 months,

consent to a sampling of biological material and participate in all planned procedures (for both mother and infant),

willingness to finish the follow-up,

Disqualifiers

type 1 or 2 diabetes diagnosed before pregnancy,

uncontrolled thyroid disease,

breastfeeding more than 1 child or being a milk donor,

tobacco/alcohol use during pregnancy or currently,

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

165 Participants
are grouped into 3 trial groups

Sponsors and collaborators

Warsaw University of Life Sciences

Lead sponsor

Wroclaw Medical University

Collaborator

National Science Centre, Poland

Collaborator

National Institute of Public Health, National Research Institute, Poland

Collaborator