Clinical trial

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

Opening soon · Not applicable · 2 countries · Registry ID NCT07457515

Opening soonNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age19 Years to Not listed

SexFemale

Healthy volunteersAccepted

ConditionBody 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

Full registry criteria

Inclusion Criteria: 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 Exclusion Criteria: 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).

Treatments and study arms

The registry does not list a named intervention.

Primary outcomes

Difference between groups and change from 1 to 6 months postpartum in maternal body fat percentage1, 3, and 6 months postpartum

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 (%).

Difference between groups and change from 1 to 6 months postpartum in maternal fat-free mass percentage1, 3, and 6 months postpartum

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 (%).

Difference between groups and change from 1 to 6 months postpartum in maternal Visceral Fat Area1, 3, and 6 months postpartum

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

Difference between groups and change from 1 to 6 months postpartum in maternal Subcutaneous Fat Area1, 3, and 6 months postpartum

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

Difference between groups and change from 1 to 6 months postpartum in maternal Body Mass Index (BMI)1, 3, and 6 months postpartum

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

Difference between groups and change from 1 to 6 months postpartum in maternal Waist-Hip Ratio (WHR)1, 3, and 6 months postpartum

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

Difference between groups and change from 1 to 6 months postpartum in maternal Waist-to-Height Ratio (WHtR)1, 3, and 6 months postpartum

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

Difference between groups and change from 1 to 6 months postpartum in metabolic syndrome (MetS) incidence1, 3, 6 months postpartum

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.

Study locations

4 locations were listed when this page was built. The first 40 are shown.

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

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Department of Human Nutrition, Institute of Human Nutrition Sciences, Warsaw University of Life Sciences (SGGW-WULS)🇵🇱 Warsaw, Masovian Voivodeship, Poland

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Monika A. Zielinska-Pukos, PhDPrincipal Investigator

Jadwiga Hamulka, ProfessorSub Investigator

Malgorzata E. Drywien, PhDSub Investigator

National Institute of Public Health NIH - National Research Institute🇵🇱 Warsaw, Masovian Voivodeship, Poland

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Wroclaw Medical University🇵🇱 Wroclaw, Lower Silesian Voivodeship, Poland

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