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

ConditionsBody 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

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age19+

SponsorWarsaw University of Life Sciences

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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,

Disqualifiers

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,

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

165 Participants

are grouped into 3 trial groups

Group A: Normal weight (NW)

Group B: Overweight (OW)

Group C: Obesity (OB)

Trial outcomes

Primary outcomes

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 (%).

Time frame

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 (%).

Time frame

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).

Time frame

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).

Time frame

1, 3, and 6 months postpartum

Secondary outcomes

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 \[kcal/d\].

Time frame

1, 3, 6 months postpartum

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.

Time frame

1, 3, 6 months postpartum

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).

Time frame

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

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

Time frame

1, 3, 6 months postpartum

Other outcomes

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

Assessment of changes in bone mineral density (BMD) using DXA.

Time frame

1, 3, 6 months postpartum

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

Assessment of changes in hydration status, assessed by urine osmolality \[mOsm/kg\].

Time frame

1, 3, 6 months postpartum

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

Assessment of maternal well-being assessed using the WHO-5 Well-being Index. Results will be expressed as a percentage score from 0 to 100, with a higher score indicating a better quality of life.

Time frame

1, 3, 6 months postpartum

Difference between groups and change from 1 to 6 months postpartum in maternal fatigue

Assessment of maternal fatigue using the Fatigue Assessment Scale (FAS). Results will be expressed as a FAS score ranging from 10 to 50, with higher scores indicating more severe fatigue.

Time frame

1, 3, 6 months postpartum

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Warsaw University of Life Sciences

Lead sponsor

Wroclaw Medical University

Collaborator

National Science Centre, Poland

Collaborator

National Institute of Public Health, National Research Institute, Poland

Collaborator

Source ClinicalTrials.gov

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