Breastmilk and the Link to Overweight/Obesity and Maternal Diet in the Mother-breastmilk-child Triad
Starting soon
Conditions studied: Body Weight, Obesity & Overweight, Human Milk/Breastfeeding, Body Composition, Maternal Cardiometabolic Health, Growth & Development, Metabolomic Profile, Infant Body Composition and Metabolism, Carotenoid Status, Fatty Acid Status, Immunologic Markers, Adipokines, Inflammation Biomarkers, Vitamin E
In brief
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.
Key facts
- Study ID
- NCT07457515
- Run by
- Warsaw University of Life Sciences
- People needed
- 165
- Starts
- 2026-02-01
- Expected to finish
- 2029-09-01
- Last updated by the study team
- 2026-03-09
Who can join
Age: 19 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- for mother:
- 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,
- well-understanding of the Polish language (for non-Polish nationalities); for infants:
- 1 month or less,
- clinically healthy,
- none or one formula feeding per day
You may not qualify if…
- for mother:
- 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,
- inability to express a sufficient amount of milk; for infants:
- congenital disease,
- birth from a multiple pregnancy,
- preterm birth (<37 Hbd).
Where it is running
- Food, Nutrition and Health, Uviversity of British Columbia; Affiliated Investigator, Healthy Starts, BC Children's Hospital Research Institute & Women's Health Research Institute — Vancouver, British Columbia, Canada
- Wroclaw Medical University — Wroclaw, Lower Silesian Voivodeship, Poland
- National Institute of Public Health NIH - National Research Institute — Warsaw, Masovian Voivodeship, Poland
- Department of Human Nutrition, Institute of Human Nutrition Sciences, Warsaw University of Life Sciences (SGGW-WULS) — Warsaw, Masovian Voivodeship, Poland
Full record on ClinicalTrials.gov
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