NCT07457515Not yet recruiting
Breastmilk and the Link to Overweight/Obesity and Maternal Diet in the Mother-breastmilk-child Triad
Analysis of the Transmission of Overweight/Obesity in the Mother-breastmilk-child Triad in Relation to Maternal Cardiometabolic Status and Diet
Source: ClinicalTrials.gov · Last updated 9 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 165 (estimated)
- First submitted
- 19 Jan 2026
- Start date
- Feb 2026
- Primary completion date
- Feb 2029
- Lead sponsor
- Warsaw University of Life Sciences
- Diseases
- Obesity
- NCT number
- NCT07457515
What you commit to
- Study type: Observational
- Planned participants: 165
- From Feb 2026 to the primary completion date, Feb 2029
- 4 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- type 1 or 2 diabetes diagnosed before pregnancy,
- uncontrolled thyroid disease,
- congenital disease,
Other
- for mother:
- 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:
- birth from a multiple pregnancy,
- preterm birth (\<37 Hbd).
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: Female · Accepts healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Food, Nutrition and Health, Uviversity of British Columbia; Affiliated Investigator, Healthy Starts, BC Children's Hospital Research Institute & Women's Health Research Institute Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Department of Human Nutrition, Institute of Human Nutrition Sciences, Warsaw University of Life Sciences (SGGW-WULS) Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| National Institute of Public Health NIH - National Research Institute Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Wroclaw Medical University Coordinator of this site? Confirm its status | Wroclaw | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.