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Body WeightBLOOM-TriadNCT07457515

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

An observational study of Body Weight and Obesity & Overweight, run by Warsaw University of Life Sciences at 4 sites in 2 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 19 years and older, women onlyHealthy volunteers can take part
How many people
165 participants
Where
4 sitesin 2 countries
Study dates
Feb 2026to Sep 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: A group of 165 mother-infant dyads is planned to be recruited from a community sample. The study group will be recruited via advertisements on the Internet, social media, health facilities, and information distributed to midwives and lactation consultants. To reduce bias related to the lack of random selection and increase the quality of our results, the investigators will match participants by maternal age, infant sex, and sociodemographic status - factors potentially affecting exposures and outcomes measured in our study.

Who may be able to join

  • 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:
Show all 9Show fewer
  • 1 month or less,
  • clinically healthy,
  • none or one formula feeding per day

Who cannot join

  • 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:
Show all 9Show fewer
  • congenital disease,
  • birth from a multiple pregnancy,
  • preterm birth (<37 Hbd).

Trial locations and contacts

4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Monika A. Zielinska-Pukos, PhD contact

+48225937125

monika_zielinska_pukos@sggw.edu.pl

Jadwiga Hamulka, Professor contact

+48225937122

jadwiga_hamulka@sggw.edu.pl

4 sites in 2 countries

Poland3 sites

  • National Institute of Public Health NIH - National Research Institute

    Warsaw, Masovian Voivodeship, 00-791

  • Department of Human Nutrition, Institute of Human Nutrition Sciences, Warsaw University of Life Sciences (SGGW-WULS)

    Warsaw, Masovian Voivodeship, 02-776

    Monika A. Zielinska-Pukos, PhD

    Jadwiga Hamulka, Professor

  • Wroclaw Medical University

    Wroclaw, Lower Silesian Voivodeship, 50-367

Other trials in Poland

Canada1 site

  • 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, V6T 1Z4

Other trials in Canada

About this study

Official title: Analysis of the Transmission of Overweight/Obesity in the Mother-breastmilk-child Triad in Relation to Maternal Cardiometabolic Status and Diet

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.

Read the detailed description

The global obesity pandemic continues to escalate, with projections showing 1 in 5 women and 1 in 7 men obese by 2030. Maternal obesity raises the risk of childhood obesity by 264%, and overweight/obese children are more prone to become obese adults.

Obesity-associated metabolic dysfunctions (inflammation, insulin resistance, dyslipidemia) heighten morbidity and mortality risks. Breastfeeding mitigates overweight/obesity risks, yet mothers with overweight/obesity often encounter challenges in initiation, continuation, and altered milk composition, showing elevated levels of leptin, insulin, and n-6/n-3 fatty acids. However, findings on other components, like total fat, fatty acids, insulin, adipokines, carotenoids, and immune factors, remain inconsistent due to methodological limitations and lack of comprehensive analysis. Nonetheless, the potential pro-inflammatory and obesogenic properties of milk produced by mothers with overweight/obesity have been discussed. Recent systematic reviews link breastmilk protein, fat, leptin, and IL-6 to infant growth and adiposity. Findings for other components remain unclear due to small samples, methodological limitations, and lack of a systemic approach to analyze breastmilk as a complex biological system. Alterations in breastmilk composition may stem from disrupted de novo synthesis, transport across the blood-breastmilk barrier, or altered circulating levels. Recent studies showed impaired de novo synthesis of C15:0 and C16:1 fatty acids, probably caused by insulin resistance and reduced long-chain fatty acid transfer linked to inflammation (suppress lipoprotein lipase activity essential for transporting lipid compounds). Hence, poor cardiometabolic status may mediate altered breastfeeding outcomes and milk composition, but it requires further studies. Studies among non-lactating individuals suggested lifestyle and diet play crucial roles in mitigating overweight/obesity metabolic implications (e.g., metabolically healthy obese (MHO) and metabolically obese with normal weight (MONW) phenotypes). Maternal diet can influence breastmilk concentration of certain diet-dependent nutrients and bioactives (e.g., fatty acids, vitamins A, D, and carotenoids). Similarly, prohealthy/unhealthy dietary patterns seem to have beneficial/unfavorable effects on breastmilk composition and breastfeeding outcomes, but results remain inconclusive. Nonetheless, some suggest that diet may mitigate the effects of maternal overweight/obesity on breastmilk composition in mothers with overweight/obesity. The mechanisms linking obesity-related changes in breastmilk to infant development remain unclear. This study addresses this gap by studying the mother-breastmilk-infant triad, focusing on maternal cardiometabolic status, diet, breastmilk composition as a complex biological system, and anthropometric and metabolic outcomes.

This study aims to elucidate the intricate interplay between maternal adiposity, cardiometabolic status, diet, and breastmilk composition and to understand the role of breastmilk in the transmission of obesity and the shaping of infant metabolic health.

Our research questions will aim to determine/explore the following questions:

Q1. How does the maternal BMI category differentiate breastmilk composition from a systemic perspective? Q2. How does maternal cardiometabolic status mediate OW/OB-related alterations in breastmilk composition? Q3. Whether (and how) maternal diet moderates OW/OB-related alterations in breastmilk composition? Q4. Whether (and how) maternal OW/OB differentiates infant metabolomic profile? Q5. Whether (and how) OW/OB-related alterations in breastmilk composition influence infant outcomes and obesity risk? Q6. Whether (and how) maternal dietary patterns moderate adverse health outcomes of maternal OW/OB in infants?

The research hypotheses assume that:

H1. Maternal OW and OB are associated with pro-inflammatory properties and altered breastmilk metabolome via obesity-related low-grade inflammation, metabolic alterations, and oxidative stress, not dietary differences.

H2. Metabolically healthy OW and OB mothers produce less altered breastmilk than metabolically unhealthy mothers, as cardiometabolic status mediates between adiposity and breastmilk composition.

H3. A pro-healthy dietary pattern attenuates, and a westernized dietary pattern exacerbates obesity-related alterations in breastmilk composition due to differences in concentrations of pro-, anti-inflammatory, and antioxidant dietary compounds.

H4. Infants of OW and OB mothers have altered growth trajectories and metabolic pathways, higher fat mass, and oxidative stress compared to infants of NW mothers.

H5. Obesity-related changes in breastmilk composition determine alterations in infant outcomes.

H6. Maternal pro-health/westernized dietary patterns and metabolic health mitigate/exacerbate the adverse effects of overweight and obesity on infant outcomes.

The investigators will verify these hypotheses based on results collected using gold standards and novel body composition assessment and analytical methods (DXA scans, HPLC, GC-MS, ELISA, and LC-MS), nutrient-based and dietary pattern-based dietary assessment with biomarkers validation, in-depth evaluation of maternal cardiometabolic status and infant outcomes, and a systemic approach to breastmilk composition analysis. The findings will lay the foundation for tailored, evidence-based interventions to disrupt the intergenerational transmission of obesity. Furthermore. contribute to advancing the health sciences discipline and decreasing the global health burden of overweight and obesity, supporting the realization of WHO's Global Nutrition Goals.

Keywords
Lactation, Body composition, Infant development, Diet, Adipokines, Carotenoids, Fatty acids, Metabolomics, Inflammation, Oxidative stress, Overweight, Obesity, Tocopherols
Medical subject headings
Body Weight, Obesity, Overweight, Breast Feeding, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07457515
Study groupRoleWhat they receive
Normal weight (NW)n=55 (maternal BMI at baseline 18.5-24.9 kg/m²)
Overweight (OW)n=55 (maternal BMI at baseline 25-29.9 kg/m²)
Obesity (OB)n=55 (maternal BMI at baseline >29.9 kg/m²)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference between groups and change from 1 to 6 months postpartum in maternal body fat percentage

    Assessment of changes in total body fat content, assessed by a bioelectrical impedance analysis (BIA) and a dual-energy X-ray absorptiometer (DXA). Results will be reported as a percentage (%).

    Measured: 1, 3, and 6 months postpartum

  2. Difference between groups and change from 1 to 6 months postpartum in maternal fat-free mass percentage

    Assessment of changes in fat-free mass, assessed by a bioelectrical impedance analysis (BIA) and a dual-energy X-ray absorptiometer (DXA). Results will be reported as a percentage (%).

    Measured: 1, 3, and 6 months postpartum

  3. Difference between groups and change from 1 to 6 months postpartum in maternal Visceral Fat Area

    Assessment of changes in visceral fat area, assessed by DXA. Results will be reported as square centimeters (cm^2).

    Measured: 1, 3, and 6 months postpartum

  4. Difference between groups and change from 1 to 6 months postpartum in maternal Subcutaneous Fat Area

    Assessment of changes in subcutaneous fat area, assessed by DXA. Results will be reported as square centimeters (cm^2).

    Measured: 1, 3, and 6 months postpartum

  5. Difference between groups and change from 1 to 6 months postpartum in maternal Body Mass Index (BMI)

    Weight and height will be combined to report BMI in kg/m^2.

    Measured: 1, 3, and 6 months postpartum

  6. Difference between groups and change from 1 to 6 months postpartum in maternal Waist-Hip Ratio (WHR)

    Assessment of fat distribution calculated as the waist measurement divided by the hip measurement (dimensionless ratio).

    Measured: 1, 3, and 6 months postpartum

  7. Difference between groups and change from 1 to 6 months postpartum in maternal Waist-to-Height Ratio (WHtR)

    Assessment of fat distribution calculated as the waist measurement divided by height (dimensionless ratio).

    Measured: 1, 3, and 6 months postpartum

  8. Difference between groups and change from 1 to 6 months postpartum in metabolic syndrome (MetS) incidence

    Assessment of MetS incidences diagnosed based on the occurence of three from five metabolic abnormalities diagnosed based on International Diabetes Federation-established cut-off points for women for waist circumference (≥80 cm), fasting blood glucose (≥100 mg/dL), triglicerides (≥150 mg/dL), HDL cholesterol (<50 mg/dL), blood pressure (systolic SBP ≥ 130 or diastolic ≥ 85 mmHg) as a marker of cardiometabolic health.

    Measured: 1, 3, 6 months postpartum

  9. Difference between groups and change from 1 to 6 months postpartum in maternal glycated haemoglobin (HbA1c)

    Assessment of changes in HbA1c (reported in %) as a marker of maternal cardiometabolic health.

    Measured: 1, 3, 6 months postpartum

  10. Difference between groups and change from 1 to 6 months postpartum in Homeostatic Model Assessment - Insulin Resistance (HOMA-IR)

    Assessment of HOMA-IR calculated as the product of fasting insulin [µIU/mL] and fasting glucose [µIU/mL] divided by 22.5 (dimensionless ratio) as an indicator of maternal cardiometabolic health.

    Measured: 1, 3, 6 months postpartum

  11. Difference between groups and change from 1 to 6 months postpartum in maternal serum leptin

    Assessment of maternal serum leptin assessed by the ELISA method as an indicator of maternal cardiometabolic health.

    Measured: 1, 3, 6 months postpartum

  12. Difference between groups and change from 1 to 6 months postpartum in maternal serum adiponectin

    Assessment of maternal serum adiponectin assessed by the ELISA method as an indicator of maternal cardiometabolic health.

    Measured: 1, 3, 6 months postpartum

  13. Difference between groups and change from 1 to 6 months postpartum in maternal serum and infant urine Retinol-Binding Protein-4 (RBP4)

    Assessment of maternal serum and infant urine RBP-4 assessed by the ELISA method as an indicator of maternal and infant cardiometabolic health.

    Measured: 1, 3, 6 months postpartum

  14. Difference between groups and change from 1 to 6 months postpartum in human milk macronutrients

    Assessment of human milk macronutrients (fat, carbohydrate, dry material, protein, true protein) concentration assessed by mid-infrared (mid-IR) transmission spectroscopy method. Results will be reported in grams per 100 mL.

    Measured: 1, 3, 6 months of postpartum

  15. Difference between groups and change from 1 to 6 months postpartum in human milk energy value

    Assessment of human milk energy value assessed by mid-infrared (mid-IR) transmission spectroscopy method. Results will be reported in kcal per 100 mL.

    Measured: 1, 3, 6 months of postpartum

  16. Difference between groups and change from 1 to 6 months postpartum in human milk secretory immunoglobulin A (S-IgA)

    Assessment of human milk S-IgA assessed by Enzyme-Linked Immunosorbent Assay (ELISA) method. Results will be reported in grams per liter [g/L].

    Measured: 1, 3, and 6 months postpartum

  17. Difference between groups and change from 1 to 6 months postpartum in human milk lactoferrin

    Assessment of human milk lactoferrin assessed by ELISA method. Results will be reported in grams per liter [g/L].

    Measured: 1, 3, and 6 months postpartum

  18. Difference between groups and change from 1 to 6 months postpartum in human milk leptin

    Assessment of human milk leptin assessed by ELISA method.

    Measured: 1, 3, 6 months of postpartum

  19. Difference between groups and change from 1 to 6 months postpartum in human milk adiponectin

    Assessment of human milk adiponectin assessed by ELISA method.

    Measured: 1, 3, 6 months of postpartum

  20. Difference between groups and change from 1 to 6 months postpartum in human milk insulin

    Assessment of human milk insulin assessed by ELISA method.

    Measured: 1, 3, 6 months of postpartum

  21. Difference between groups and change from 1 to 6 months postpartum in human milk High-Sensitivity C-Reactive Protein (hs-CRP)

    Assessment of human milk hsCRP assessed by ELISA method.

    Measured: 1, 3, 6 months of postpartum

  22. Difference between groups and change from 1 to 6 months postpartum in human milk interleukin 1 (IL-1)

    Assessment of human milk IL-1 assessed by ELISA method.

    Measured: 1, 3, 6 months of postpartum

  23. Difference between groups and change from 1 to 6 months postpartum in human milk interleukin 6 (IL-6)

    Assessment of human milk IL-6 assessed by ELISA method.

    Measured: 1, 3, 6 months of postpartum

  24. Difference between groups and change from 1 to 6 months postpartum in human milk Tumor Necrosis Factor-alpha (TNF-alfa)

    Assessment of human milk TNF-alfa assessed by ELISA method.

    Measured: 1, 3, 6 months of postpartum

  25. Difference between groups and change from 1 to 6 months postpartum in human milk fatty acid profile

    Assessment of human milk fatty acid profile analyzed as methyl ester (FAME) by gas chromatography. Results will be reported as concentration within a total fat [% wt/wt].

    Measured: 1, 3, 6 months of postpartum

  26. Difference between groups and the change from 1 to 6 months of life in infant anthropometric development

    Assessment of anthropometric development calculated as weight-, length-, BMI-, and head circumference z-scores for age and sex, analyzed based on WHO standards.

    Measured: 1, 3, 6 months of life

  27. Difference between groups and the change from 1 to 6 months of life in infant body fat-free mass percentage

    Assessment of changes in total body fat-free mass content, assessed by the whole-body DXA scans with a vacuum cushion to prevent movement. Results will be reported as a percentage (%).

    Measured: 1, 6 months of life

  28. Difference between groups and the change from 1 to 6 months of life in infant body fat percentage

    Assessment of changes in total body fat content, assessed by the whole-body DXA scans with a vacuum cushion to prevent movement. Results will be reported as a percentage (%).

    Measured: 1, 6 months of life

Secondary outcomes (13)

  1. Difference between groups and the change from 1 to 6 months postpartum in the maternal resting metabolic rate (RMR)

    Assessment of the rate of maternal energy metabolism assessed by indirect calorimetry. Results will be reported as kilocalories per day [kcal/d].

    Measured: 1, 3, 6 months postpartum

  2. Difference between groups and the change from 1 to 6 months postpartum in maternal dietary intake

    Assessment of maternal dietary intake using 3-day food records.

    Measured: 1, 3, 6 months postpartum

  3. Difference between groups and the change from 1 to 6 months postpartum in maternal dietary habits

    Assessment of maternal dietary intake using a food frequency questionnaire (FFQ).

    Measured: 1, 3, 6 months postpartum

  4. Difference between groups and change from 1 to 6 months postpartum in maternal short- and long-term fatty acid status

    Assessment of serum blood and erythrocyte membranes fatty acids profile analyzed by gas chromatography. Results will be reported as concentration within a total fat [% wt/wt].

    Measured: 1, 3, 6 months postpartum

  5. Difference between groups and change from 1 to 6 months postpartum in maternal and human milk lipophilic antioxidants and vitamins

    Assessment of plasma and human milk carotenoids, retinol, and vitamin E, as well as serum vitamin D (25(OH)D) analyzed by high-performance liquid chromatography (HPLC). Results will be reported as micromoles per liter [µmol/L].

    Measured: 1, 3, 6 months postpartum

  6. Difference between groups and the change from 1 to 6 months of life in infant skin carotenoid status

    Assessment of skin carotenoids assessed by reflectance spectroscopy with Veggie Meter (Longevity Link, Ltd.). Results will be reported as a skin carotenoid score (SCS; 0-800, higher values mean more carotenoids)

    Measured: 1, 3, 6 months of life

  7. Difference between groups and change from 1 to 6 months postpartum in maternal and infant urine 8-isoprostane

    Assessment of maternal and infant urine 8-isoprostane analyzed by the ELISA as an indicator of oxidative stress. Results will be reported as picograms per milligram of creatinine [pg per mg of creatinine].

    Measured: 1, 3, 6 months postpartum

  8. Difference between groups and change from 1 to 6 months postpartum in maternal serum hsCRP

    Assessment of maternal serum hsCRP assessed by the ELISA method as an indicator of systemic inflammation.

    Measured: 1, 3, 6 months postpartum

  9. Difference between groups and change from 1 to 6 months postpartum in maternal serum IL-1

    Assessment of maternal serum IL-1 assessed by the ELISA method as an indicator of systemic inflammation.

    Measured: 1, 3, 6 months postpartum

  10. Difference between groups and change from 1 to 6 months postpartum in maternal serum IL-6

    Assessment of maternal serum IL-6 assessed by the ELISA method as an indicator of systemic inflammation.

    Measured: 1, 3, 6 months postpartum

  11. Difference between groups and change from 1 to 6 months postpartum in maternal serum TNF-alfa

    Assessment of maternal serum TNF-alfa assessed by the ELISA method as an indicator of systemic inflammation.

    Measured: 1, 3, 6 months postpartum

  12. Difference between groups and change from 1 to 3 months postpartum in human milk lipidomics

    Assessment of human milk triacylglycerols (TG), diacylglycerols (DG), phosphatidylcholine (PC), sphingomyelin (SM), and phosphatidylethanolamine (PE) assessed by targeted lipidomic analysis using the LC-MS. Results expressed as the percentage relative amount of many lipid species.

    Measured: 1, 3 months postpartum

  13. Difference between groups and change from 1 to 6 months postpartum in metabolomic profile of maternal serum blood and infant urine

    Assessment of the serum and urine non-targeted metabolomic profiles.

    Measured: 1, 3, 6 months postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2026
  2. Study startFeb 2026 (estimated)
  3. Primary completionFeb 2029 (estimated)
  4. Study completionSep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
165 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07457515
Sponsor's protocol ID
2024/55/B/NZ9/01126
Acronym
BLOOM-Triad
Status last verified
Jan 2026
First submitted
19 Jan 2026
Last updated
9 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • WHO/UNICEF. (2019). Recommendations for data collection, analysis and reporting on anthropometric indicators in children under 5 years old (W. H. O. and the U. N. C. F. (UNICEF) (ed.)).

  • CDC. National Health and Nutrition Examination Survey (NHANES): Anthropometry Procedures Manual. 2020. https://wwwn.cdc.gov/nchs/data/nhanes/public/2019/manuals/2020-Anthropometry-Procedures-Manual-508.pdf

  • Zielinska-Pukos, M. A., Wesołowska, A., & Hamułka, J. (2024d). Longitudinal and circadian variation in breastmilk macronutrient composition across the first six months of lactation - associations with maternal determinants and infant anthropometric development. Acta Sci. Pol. Technol. Aliment, 23(1), 65-76.

  • Zielinska-Pukos MA, Michalska-Kacymirow M, Kurek E, Bulska E, Grabowicz-Chadrzynska I, Wesolowska A, Hamulka J. Breastmilk mineral composition among well-educated mothers from Central Poland - Associations with maternal dietary intake, dietary patterns and infant psychomotor development. J Trace Elem Med Biol. 2024 May;83:127393. doi: 10.1016/j.jtemb.2024.127393. Epub 2024 Jan 13.

    PubMed 38271826

  • Zielinska-Pukos MA, Kopiasz L, Hamulka J. The Effect of Maternal Overweight/Obesity on Serum and Breastmilk Leptin, and Its Associations with Body Composition, Cardiometabolic Health Indices, and Maternal Diet: The BLOOM Study. Metabolites. 2024 Apr 13;14(4):221. doi: 10.3390/metabo14040221.

    PubMed 38668349

  • Zielinska-Pukos MA, Kopiasz L, Hamulka J. No effect of circulating leptin on energy metabolism in normal weight or overweight/obese lactating mothers: The case-control Breastmilk and the Link to Overweight/Obesity and Maternal diet (BLOOM) study. Clin Nutr ESPEN. 2024 Oct;63:878-886. doi: 10.1016/j.clnesp.2024.08.025. Epub 2024 Aug 30.

    PubMed 39209029

  • Zielinska-Pukos MA, Brys J, Wesolowska A, Hamulka J. Breastmilk PUFA strongly associated with maternal dietary intake but not anthropometric parameters and breastmilk carotenoids. Prostaglandins Leukot Essent Fatty Acids. 2022 Nov;186:102505. doi: 10.1016/j.plefa.2022.102505. Epub 2022 Oct 9.

    PubMed 36279603

  • Zielinska-Pukos MA, Brys J, Kucharz N, Chrobak A, Wesolowska A, Grabowicz-Chadrzynska I, Hamulka J. Factors Influencing Cortisol Concentrations in Breastmilk and Its Associations with Breastmilk Composition and Infant Development in the First Six Months of Lactation. Int J Environ Res Public Health. 2022 Nov 10;19(22):14809. doi: 10.3390/ijerph192214809.

    PubMed 36429527

  • Zielinska MA, Hamulka J, Wesolowska A. Carotenoid Content in Breastmilk in the 3rd and 6th Month of Lactation and Its Associations with Maternal Dietary Intake and Anthropometric Characteristics. Nutrients. 2019 Jan 18;11(1):193. doi: 10.3390/nu11010193.

    PubMed 30669320

  • Zielinska MA, Wesolowska A, Pawlus B, Hamulka J. Health Effects of Carotenoids during Pregnancy and Lactation. Nutrients. 2017 Aug 4;9(8):838. doi: 10.3390/nu9080838.

    PubMed 28777356

  • Zhou XD, Chen QF, Yang W, Zuluaga M, Targher G, Byrne CD, Valenti L, Luo F, Katsouras CS, Thaher O, Misra A, Ataya K, Oviedo RJ, Pik-Shan Kong A, Alswat K, Lonardo A, Wong YJ, Abu-Abeid A, Al Momani H, Ali A, Molina GA, Szepietowski O, Jumaev NA, Kizilkaya MC, Viveiros O, Toro-Huamanchumo CJ, Yen Kok KY, Ospanov O, Abbas SI, Robertson AG, Fouad Y, Mantzoros CS, Zhang H, Mendez-Sanchez N, Sookoian S, Chan WK, Treeprasertsuk S, Adams L, Ocama P, Ryan JD, Perera N, Sharara AI, Al-Busafi SA, Opio CK, Garcia M, Lim-Loo MC, Ruiz-Ucar E, Prasad A, Casajoana A, Abdelbaki TN, Zheng MH. Burden of disease attributable to high body mass index: an analysis of data from the Global Burden of Disease Study 2021. EClinicalMedicine. 2024 Sep 24;76:102848. doi: 10.1016/j.eclinm.2024.102848. eCollection 2024 Oct.

    PubMed 39386160

  • Zaidi Y, Stroh R, Moran NE. Systematic review of carotenoid concentrations in human milk and infant blood. Nutr Rev. 2022 Aug 8;80(9):2029-2050. doi: 10.1093/nutrit/nuac018.

    PubMed 35389473

  • Yin WJ, Wang P, Ma SS, Tao RX, Hu HL, Jiang XM, Zhang Y, Tao FB, Zhu P. Vitamin D supplementation for cardiometabolic risk markers in pregnant women based on the gestational diabetes mellitus or obesity status : a randomized clinical trial. Eur J Nutr. 2024 Oct;63(7):2599-2609. doi: 10.1007/s00394-024-03443-6. Epub 2024 Jun 15.

    PubMed 38878202

  • Yan S, Chen S, Liu Y, Liang H, Zhang X, Zhang Q, Xiu J. Associations of serum carotenoids with visceral adiposity index and lipid accumulation product: a cross-sectional study based on NHANES 2001-2006. Lipids Health Dis. 2023 Nov 30;22(1):209. doi: 10.1186/s12944-023-01945-6.

    PubMed 38037060

  • World Obesity Federation. (2022). World Obesity Atlas 2022. World Obesity Federation.

Questions about this trial

What is this clinical trial studying?

An observational study of Body Weight and Obesity & Overweight, run by Warsaw University of Life Sciences at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Poland, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Monika A. Zielinska-Pukos, PhD (+48225937125, monika_zielinska_pukos@sggw.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference between groups and change from 1 to 6 months postpartum in maternal body fat percentage (time frame: 1, 3, and 6 months postpartum). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07457515, which also lists 48 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.

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