Effect of Exercise Training on Breastmilk Composition

Not Applicable

Recruiting

• Conditions: Obesity
• Interventions: Behavioral: Exercise

• Registration Number: NCT05488964
• Lead Sponsor: Norwegian University of Science and Technology

Brief Summary

The aim of this trial is to investigate whether regular endurance exercise during the lactation period will influence breastmilk composition among individuals with overweight/obesity, and secondarily to assess if such changes impact the growth and health of the infants.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-06
• Study First Submitted QC: 2022-08-03
• Study First Posted: 2022-08-05
• Study Start: 2022-09-01
• Status Verified: 2024-08
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-21
• Primary Completion: 2025-09
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 62

Inclusion Criteria

• Female
• Aged 18 years or older
• Body mass index ≥ 25 kg/m2 pre-pregnancy and/or BMI ≥ 28 kg/m2 postpartum
• Given birth to a singleton term (after 37 weeks + 0 days) baby
• 6-7 weeks postpartum at time of inclusion
• Exclusively breastfeeding the baby (no other foods are given) and intend to continue this practice for ≥ 8 weeks at inclusion
• Understands oral and written Norwegian

Exclusion Criteria

• On-going pregnancy
• Known type 1 or type 2 diabetes
• Known cardiovascular disease
• High intensity exercise more than twice weekly the last three months before inclusion and/or an intention to start regular endurance training within the next 8 weeks at baseline

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise	Regular endurance training for 8 weeks

Primary Outcome Measures

Name	Time	Method
Breastmilk human milk oligosaccharide (HMO) 3'sialyllactose (3'SL)	0 to 8 weeks	Relative concentration of 3'SL in breastmilk

Secondary Outcome Measures

Name	Time	Method
Infant microRNA	0 to 8 weeks	Sequencing
Maternal systolic blood pressure	After 9 months from baseline	Automatic cuff
Maternal diastolic blood pressure	After 9 months from baseline	Automatic cuff
Infant muscle mass	After 9 months from baseline	Impedance scale
Maternal insulin sensitivity	0 to 8 weeks	Homeostatic model assessment of insulin resistance (HOMA-IR)
Maternal fasting circulating insulin C-peptide concentrations	0 to 8 weeks	From fasting venous blood sampling
Maternal circulating total cholesterol concentrations	After 9 months from baseline	From fasting venous blood sampling
Maternal fat-free mass	After 9 months from baseline	Impedance scale
Maternal cardiorespiratory fitness	After 9 months from baseline	Maximum oxygen uptake via direct gas exchange
Infant fat mass	After 9 months from baseline	Impedance scale
Breastmilk human milk oligosaccharide (HMO) 3'sialyllactose (3'SL)	0 to 4 weeks	Relative concentration of 3'SL in breastmilk
Breastmilk microRNA	0 to 4 weeks	RNA sequencing
Maternal fasting circulating glucose concentrations	After 9 months from baseline	From fasting venous blood sampling
Infant total body mass (trajectories)	Infant age 24 months	From health records
Maternal physical activity	After 9 months from baseline	Minutes of high-intensity physical activity per week, self-reported (questionnaire)
Breastmilk metabolites	0 to 4 weeks	Relative concentrations of metabolites in breastmilk determined using untargeted metabolomics profiling (mass spectrometry)
Maternal circulating high-sensitivity c-reactive protein	After 9 months from baseline	From fasting venous blood sampling
Maternal visceral fat area	After 9 months from baseline	Impedance scale
Maternal bone mass	After 9 months from baseline	Impedance scale
Maternal circulating high-density lipoprotein (HDL) concentrations	After 9 months from baseline	From fasting venous blood sampling
Maternal circulating triglycerides concentrations	After 9 months from baseline	From fasting venous blood sampling
Maternal fat mass	After 9 months from baseline	Impedance scale
Infant total body mass	After 9 months from baseline	Impedance scale
Infant hydration status	After 9 months from baseline	Impedance scale
Infant length (trajectories)	Infant age 10 months	From health records
Maternal circulating low-density lipoprotein (LDL) concentrations	After 9 months from baseline	From fasting venous blood sampling
Maternal glycated hemoglobin (HbA1c)	After 9 months from baseline	From fasting venous blood sampling
Maternal total body mass	After 9 months from baseline	Impedance scale
Maternal waist circumference	After 9 months from baseline	Measuring tape
Maternal nutrition	0 to 8 weeks	Diet diary completed for four days at baseline and at study completion
Maternal psychological well-being	After 9 months from baseline	Self-reported (questionnaire)
Infant bone density	After 9 months from baseline	Impedance scale
Infant head circumference (trajectories)	Infant age 24 months	From health records
Infant height (trajectories)	Infant age 24 months	From health records
Infant gut microbiota	0 to 8 weeks	Sequencing

Trial Locations

Locations (1)

Dept Circulation and Medical Imaging, EXCAR Exercise Lab; 🇳🇴 Trondheim, Norway