NCT07457515: BLOOM-Triad

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

Not yet recruiting Last updated 2 March 2026

What this trial tests

trial in Body Weight in 165 participants. Not yet recruiting.

Timeline

1 February 2026

Primary endpoint
1 February 2029

1 September 2029

Quick facts

Lead sponsor	Warsaw University of Life Sciences
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	165
Start date	1 February 2026
Primary completion	1 February 2029
Estimated completion	1 September 2029
Sites	4 locations across Canada, Poland

Conditions studied

• Body Weight — all drugs for Body Weight →
• Obesity & Overweight — all drugs for Obesity & Overweight →
• Human Milk/Breastfeeding — all drugs for Human Milk/Breastfeeding →
• Body Composition — all drugs for Body Composition →

Sponsor

Warsaw University of Life Sciences

Who can join

19 and older, female only, with Body Weight or Obesity & Overweight. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Difference between groups and change from 1 to 6 months postpartum in maternal body fat percentage
  Time frame: 1, 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 percentage
  Time frame: 1, 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 Area
  Time frame: 1, 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 Area
  Time frame: 1, 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)
  Time frame: 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)
  Time frame: 1, 3, and 6 months postpartum
  Assessment of fat distribution calculated as the waist measurement divided by the hip measurement (dimensionless ratio).

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.