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

NCT07457515 | Not Yet Recruiting

• 1 other identifier: 2024/55/B/NZ9/01126
• Study Type: observational
• Target: 165
• Locations: 2 countries
• Sites: 4

Brief 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. 1.maternal anthropometry and body composition;
2. 2.maternal dietary intake and dietary patterns (with results of biomarker-based validation);
3. 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. 4.maternal metabolomics, adipokines, insulin, selected biomarkers of inflammation, altered glucose metabolism, and oxidation;
5. 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. 6.infant growth trajectory, body composition, urine metabolomics, and biomarkers of oxidative stress.

Conditions

Metabolomic Profile; Vitamin E; Body Weight; Obesity & Overweight; Human Milk/Breastfeeding; Body Composition; Maternal Cardiometabolic Health; Growth & Development; Infant Body Composition and Metabolism; Carotenoid Status; Fatty Acid Status; Immunologic Markers; Adipokines; Inflammation Biomarkers

Keywords

Lactation; Body composition; Infant development; Diet; Adipokines; Carotenoids; Fatty acids; Metabolomics; Inflammation; Oxidative stress; Overweight; Obesity; Tocopherols

Outcome Measures

Primary Outcomes (28)

• 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 (%).

  1, 3, and 6 months postpartum

• 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 (%).

  1, 3, and 6 months postpartum

• 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).

  1, 3, and 6 months postpartum

• 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).

  1, 3, and 6 months postpartum

• 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.

  1, 3, and 6 months postpartum

• 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).

  1, 3, and 6 months postpartum

• 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).

  1, 3, and 6 months postpartum

• 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.

  1, 3, 6 months postpartum

• 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.

  1, 3, 6 months postpartum

• 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.

  1, 3, 6 months postpartum

• 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.

  1, 3, 6 months postpartum

• 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.

  1, 3, 6 months postpartum

• 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.

  1, 3, 6 months postpartum

• 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.

  1, 3, 6 months of postpartum

• 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.

  1, 3, 6 months of postpartum

• 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 \[g/L\].

  1, 3, and 6 months postpartum

• 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 \[g/L\].

  1, 3, and 6 months postpartum

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

  Assessment of human milk leptin assessed by ELISA method.

  1, 3, 6 months of postpartum

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

  Assessment of human milk adiponectin assessed by ELISA method.

  1, 3, 6 months of postpartum

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

  Assessment of human milk insulin assessed by ELISA method.

  1, 3, 6 months of postpartum

• 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.

  1, 3, 6 months of postpartum

• 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.

  1, 3, 6 months of postpartum

• 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.

  1, 3, 6 months of postpartum

• 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.

  1, 3, 6 months of postpartum

• 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 \[% wt/wt\].

  1, 3, 6 months of postpartum

• 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.

  1, 3, 6 months of life

• 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 (%).

  1, 6 months of life

• 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 (%).

  1, 6 months of life

Secondary Outcomes (13)

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

  1, 3, 6 months postpartum

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

  1, 3, 6 months postpartum

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

  1, 3, 6 months postpartum

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

  1, 3, 6 months postpartum

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

  1, 3, 6 months postpartum

Other Outcomes (7)

• Difference between groups and change from 1 to 6 months postpartum in Bone Mineral Density (BMD)

  1, 3, 6 months postpartum

• Difference between groups and change from 1 to 6 months postpartum in maternal hydration status

  1, 3, 6 months postpartum

• Difference between groups and change from 1 to 6 months postpartum in maternal well-being

  1, 3, 6 months postpartum

Study Arms (3)

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)

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

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:
• 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).

Sponsors & Collaborators

• Warsaw University of Life Sciences: lead
• Wroclaw Medical University: collaborator
• National Science Centre, Poland: collaborator
• National Institute of Public Health, National Research Institute, Poland: collaborator

Study Sites (4)

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, Canada

Location

Wroclaw Medical University

Wroclaw, Lower Silesian Voivodeship, 50-367, Poland

Location

National Institute of Public Health NIH - National Research Institute

Warsaw, Masovian Voivodeship, 00-791, Poland

Location

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

Warsaw, Masovian Voivodeship, 02-776, Poland

Location

Related Publications (48)

• 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.)).

  BACKGROUND

• 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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 38271826 BACKGROUND

• 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.

  PMID: 38668349 BACKGROUND

• 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.

  PMID: 39209029 BACKGROUND

• 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.

  PMID: 36279603 BACKGROUND

• 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.

  PMID: 36429527 BACKGROUND

• 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.

  PMID: 30669320 BACKGROUND

• 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.

  PMID: 28777356 BACKGROUND

• 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.

  PMID: 39386160 BACKGROUND

• 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.

  PMID: 35389473 BACKGROUND

• 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.

  PMID: 38878202 BACKGROUND

• 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.

  PMID: 38037060 BACKGROUND

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

  BACKGROUND

• World Health Organization. (2022). WHO European Regional Obesity Report 2022. WHO Regional Office for Europe

  BACKGROUND

• Walker RE, Harvatine KJ, Ross AC, Wagner EA, Riddle SW, Gernand AD, Nommsen-Rivers LA. Fatty Acid Transfer from Blood to Milk Is Disrupted in Mothers with Low Milk Production, Obesity, and Inflammation. J Nutr. 2023 Jan 14;152(12):2716-2726. doi: 10.1093/jn/nxac220.

  PMID: 36208911 BACKGROUND

• Sivalogan K, Liang D, Accardi C, Diaz-Artiga A, Hu X, Mollinedo E, Ramakrishnan U, Teeny SN, Tran V, Clasen TF, Thompson LM, Sinharoy SS. Human Milk Composition Is Associated with Maternal Body Mass Index in a Cross-Sectional, Untargeted Metabolomics Analysis of Human Milk from Guatemalan Mothers. Curr Dev Nutr. 2024 Apr 10;8(5):102144. doi: 10.1016/j.cdnut.2024.102144. eCollection 2024 May.

  PMID: 38726027 BACKGROUND

• Scime NV, Turner S, Miliku K, Simons E, Moraes TJ, Field CJ, Turvey SE, Subbarao P, Mandhane PJ, Azad MB. Association of Human Milk Fatty Acid Composition with Maternal Cardiometabolic Diseases: An Exploratory Prospective Cohort Study. Breastfeed Med. 2024 May;19(5):357-367. doi: 10.1089/bfm.2024.0019. Epub 2024 Mar 19.

  PMID: 38501380 BACKGROUND

• Ross MG, Kavasery MP, Cervantes MK, Han G, Horta B, Coca KP, Costa SO, Desai M. High-Fat, High-Calorie Breast Milk in Women with Overweight or Obesity and Its Association with Maternal Serum Insulin Concentration and Triglycerides Levels. Children (Basel). 2024 Jan 23;11(2):141. doi: 10.3390/children11020141.

  PMID: 38397253 BACKGROUND

• Reyes SM, Brockway MM, McDermid JM, Chan D, Granger M, Refvik R, Sidhu KK, Musse S, Monnin C, Lotoski L, Geddes DT, Jehan F, Kolsteren P, Allen LH, Hampel D, Eriksen KG, Rodriguez N, Azad MB. Human Milk Micronutrients and Child Growth and Body Composition in the First 2 years: A Systematic Review. Adv Nutr. 2024 Jan;15(1):100082. doi: 10.1016/j.advnut.2023.06.005. Epub 2023 Jun 13.

  PMID: 37315898 BACKGROUND

• Panagos PG, Vishwanathan R, Penfield-Cyr A, Matthan NR, Shivappa N, Wirth MD, Hebert JR, Sen S. Breastmilk from obese mothers has pro-inflammatory properties and decreased neuroprotective factors. J Perinatol. 2016 Apr;36(4):284-90. doi: 10.1038/jp.2015.199. Epub 2016 Jan 7.

  PMID: 26741571 BACKGROUND

• O'Sullivan A, Brady E, Lafferty L, O'Shea F, O'Regan Z, Meurs N, Baldini M, Gengatharan J, Metallo CM, Wallace M. Long chain monomethyl branched-chain fatty acid levels in human milk vary with gestational weight gain. Prostaglandins Leukot Essent Fatty Acids. 2024 Feb;201:102607. doi: 10.1016/j.plefa.2024.102607. Epub 2024 Jan 22.

  PMID: 38277883 BACKGROUND

• Nommsen-Rivers LA. Does Insulin Explain the Relation between Maternal Obesity and Poor Lactation Outcomes? An Overview of the Literature. Adv Nutr. 2016 Mar 15;7(2):407-14. doi: 10.3945/an.115.011007. Print 2016 Mar.

  PMID: 26980825 BACKGROUND

• Lis-Kuberka J, Pupek M, Orczyk-Pawilowicz M. The Mother-Child Dyad Adipokine Pattern: A Review of Current Knowledge. Nutrients. 2023 Sep 19;15(18):4059. doi: 10.3390/nu15184059.

  PMID: 37764842 BACKGROUND

• Leghi GE, Netting MJ, Lai CT, Narayanan A, Dymock M, Rea A, Wlodek ME, Geddes DT, Muhlhausler BS. Reduction in Maternal Energy Intake during Lactation Decreased Maternal Body Weight and Concentrations of Leptin, Insulin and Adiponectin in Human Milk without Affecting Milk Production, Milk Macronutrient Composition or Infant Growth. Nutrients. 2021 May 31;13(6):1892. doi: 10.3390/nu13061892.

  PMID: 34072910 BACKGROUND

• Keyes M, Andrews C, Midya V, Carrasco P, Guxens M, Jimeno-Romero A, Murcia M, Rodriguez-Dehli C, Romaguera D, Santa-Maria L, Vafeiadi M, Chatzi L, Oken E, Vrijheid M, Valvi D, Sen S. Mediators of the association between maternal body mass index and breastfeeding duration in 3 international cohorts. Am J Clin Nutr. 2023 Jul;118(1):255-263. doi: 10.1016/j.ajcnut.2023.04.004. Epub 2023 May 18.

  PMID: 37407164 BACKGROUND

• Karbasi S, Mohamadian M, Naseri M, Khorasanchi Z, Zarban A, Bahrami A, Ferns GA. A Mediterranean diet is associated with improved total antioxidant content of human breast milk and infant urine. Nutr J. 2023 Feb 23;22(1):11. doi: 10.1186/s12937-023-00841-0.

  PMID: 36823634 BACKGROUND

• Karbasi S, Bahrami A, Hanafi-Bojd MY, Khorasanchi Z, Zarban A, Ferns GA. Maternal Adherence to a Dietary Approaches to Stop Hypertension (DASH) Dietary Pattern and the Relationship to Breast Milk Nutrient Content. Matern Child Health J. 2023 Feb;27(2):385-394. doi: 10.1007/s10995-022-03552-w. Epub 2023 Jan 6.

  PMID: 36607482 BACKGROUND

• Kahleova H, Salas-Salvado J, Rahelic D, Kendall CW, Rembert E, Sievenpiper JL. Dietary Patterns and Cardiometabolic Outcomes in Diabetes: A Summary of Systematic Reviews and Meta-Analyses. Nutrients. 2019 Sep 13;11(9):2209. doi: 10.3390/nu11092209.

  PMID: 31540227 BACKGROUND

• Hashemi Javaheri FS, Karbin K, Senobari MA, Hakim HG, Hashemi M. The association between maternal body mass index and breast milk composition: a systematic review. Nutr Rev. 2025 Jan 1;83(1):83-111. doi: 10.1093/nutrit/nuad174.

  PMID: 38273741 BACKGROUND

• Isganaitis E, Venditti S, Matthews TJ, Lerin C, Demerath EW, Fields DA. Maternal obesity and the human milk metabolome: associations with infant body composition and postnatal weight gain. Am J Clin Nutr. 2019 Jul 1;110(1):111-120. doi: 10.1093/ajcn/nqy334.

  PMID: 30968129 BACKGROUND

• Horesh A, Tsur AM, Bardugo A, Twig G. Adolescent and Childhood Obesity and Excess Morbidity and Mortality in Young Adulthood-a Systematic Review. Curr Obes Rep. 2021 Sep;10(3):301-310. doi: 10.1007/s13679-021-00439-9. Epub 2021 May 5.

  PMID: 33950400 BACKGROUND

• Heslehurst N, Vieira R, Akhter Z, Bailey H, Slack E, Ngongalah L, Pemu A, Rankin J. The association between maternal body mass index and child obesity: A systematic review and meta-analysis. PLoS Med. 2019 Jun 11;16(6):e1002817. doi: 10.1371/journal.pmed.1002817. eCollection 2019 Jun.

  PMID: 31185012 BACKGROUND

• Hamulka J, Sulich A, Gornicka M, Jeruszka-Bielak M. Changes in Plasma Carotenoid Concentrations during the AntioxObesity Weight Reduction Program among Adults with Excessive Body Weight. Nutrients. 2023 Nov 23;15(23):4890. doi: 10.3390/nu15234890.

  PMID: 38068747 BACKGROUND

• Graille M, Wild P, Sauvain JJ, Hemmendinger M, Guseva Canu I, Hopf NB. Urinary 8-isoprostane as a biomarker for oxidative stress. A systematic review and meta-analysis. Toxicol Lett. 2020 Aug 1;328:19-27. doi: 10.1016/j.toxlet.2020.04.006. Epub 2020 Apr 19.

  PMID: 32320775 BACKGROUND

• Fron A, Orczyk-Pawilowicz M. Understanding the Immunological Quality of Breast Milk in Maternal Overweight and Obesity. Nutrients. 2023 Dec 5;15(24):5016. doi: 10.3390/nu15245016.

  PMID: 38140275 BACKGROUND

• Frackiewicz J, Ciecierska A, Bialkowska A, Drywien M, Hamulka J. Hydration status in adults with metabolic disorders in relation to socioeconomic, lifestyle and health factors. PLoS One. 2024 Jul 5;19(7):e0305540. doi: 10.1371/journal.pone.0305540. eCollection 2024.

  PMID: 38968180 BACKGROUND

• Falize C, Savage M, Jeanes YM, Dyall SC. Evaluating the relationship between the nutrient intake of lactating women and their breast milk nutritional profile: a systematic review and narrative synthesis. Br J Nutr. 2024 Apr 14;131(7):1196-1224. doi: 10.1017/S0007114523002775. Epub 2023 Dec 6.

  PMID: 38053371 BACKGROUND

• Demerath EW, Fields DA. Body composition assessment in the infant. Am J Hum Biol. 2014 May-Jun;26(3):291-304. doi: 10.1002/ajhb.22500. Epub 2014 Jan 15.

  PMID: 24424686 BACKGROUND

• Dalrymple KV, Briley AL, Tydeman FAS, Seed PT, Singh CM, Flynn AC, White SL, Poston L; UPBEAT Consortium. Breastfeeding behaviours in women with obesity; associations with weight retention and the serum metabolome: a secondary analysis of UPBEAT. Int J Obes (Lond). 2024 Oct;48(10):1472-1480. doi: 10.1038/s41366-024-01576-6. Epub 2024 Jul 24.

  PMID: 39048696 BACKGROUND

• Cheema AS, Stinson LF, Rea A, Lai CT, Payne MS, Murray K, Geddes DT, Gridneva Z. Human Milk Lactose, Insulin, and Glucose Relative to Infant Body Composition during Exclusive Breastfeeding. Nutrients. 2021 Oct 22;13(11):3724. doi: 10.3390/nu13113724.

  PMID: 34835980 BACKGROUND

• Chatzi CA, Basios A, Markozannes G, Ntzani EE, Tsilidis KK, Kazakos K, Agouridis AP, Barkas F, Pappa M, Katsiki N, Rizos EC. Effect of Different Dietary Patterns on Cardiometabolic Risk Factors: An Umbrella Review of Systematic Reviews and Meta-Analyses. Nutrients. 2024 Nov 13;16(22):3873. doi: 10.3390/nu16223873.

  PMID: 39599660 BACKGROUND

• Chang YS, Glaria AA, Davie P, Beake S, Bick D. Breastfeeding experiences and support for women who are overweight or obese: A mixed-methods systematic review. Matern Child Nutr. 2020 Jan;16(1):e12865. doi: 10.1111/mcn.12865. Epub 2019 Aug 6.

  PMID: 31240826 BACKGROUND

• Brockway MM, Daniel AI, Reyes SM, Granger M, McDermid JM, Chan D, Refvik R, Sidhu KK, Musse S, Patel PP, Monnin C, Lotoski L, Geddes D, Jehan F, Kolsteren P, Allen LH, Hampel D, Eriksen KG, Rodriguez N, Azad MB. Human Milk Macronutrients and Child Growth and Body Composition in the First Two Years: A Systematic Review. Adv Nutr. 2024 Jan;15(1):100149. doi: 10.1016/j.advnut.2023.100149. Epub 2023 Nov 18.

  PMID: 37981047 BACKGROUND

• Brockway MM, Daniel AI, Reyes SM, Gauglitz JM, Granger M, McDermid JM, Chan D, Refvik R, Sidhu KK, Musse S, Patel PP, Monnin C, Lotoski L, Geddes DT, Jehan F, Kolsteren P, Bode L, Eriksen KG, Allen LH, Hampel D, Rodriguez N, Azad MB. Human Milk Bioactive Components and Child Growth and Body Composition in the First 2 Years: A Systematic Review. Adv Nutr. 2024 Jan;15(1):100127. doi: 10.1016/j.advnut.2023.09.015. Epub 2023 Oct 4.

  PMID: 37802214 BACKGROUND

• Badoud F, Lam KP, DiBattista A, Perreault M, Zulyniak MA, Cattrysse B, Stephenson S, Britz-McKibbin P, Mutch DM. Serum and adipose tissue amino acid homeostasis in the metabolically healthy obese. J Proteome Res. 2014 Jul 3;13(7):3455-66. doi: 10.1021/pr500416v. Epub 2014 Jun 23.

  PMID: 24933025 BACKGROUND

• Asadi Z,Bahrami A,Zarban A,Asadian AH,Ferns GA,Karbasi S

  BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Maternal: * serum, * erythrocytes, * human milk, * urine, * stool, * buccal swab. Infant: * urine, * stool, * buccal swab.

MeSH Terms

Conditions

Body Weight; Obesity; Overweight; Breast Feeding; Inflammation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Feeding Behavior; Behavior; Pathologic Processes

Central Study Contacts

Monika A. Zielinska-Pukos, PhD

CONTACT

+48225937125; monika_zielinska_pukos@sggw.edu.pl

Jadwiga Hamulka, Professor

CONTACT

+48225937122; jadwiga_hamulka@sggw.edu.pl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: March 9, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: March 9, 2026

Record last verified: 2026-01

Locations

PL (3); CA (1)