Acute Effects of Endurance Exercise on Breast Milk Composition in Women With Overweight/Obesity

NCT05745922 — Not applicable, Completed, 32 participants, Norwegian University of Science and Technology

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Acute Effects of Endurance Exercise With Moderate and High Intensity on Breast Milk Composition Among Women With Overweight/Obesity

Registry	NCT05745922, acronym YT
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: single, basic science
Enrollment	32 (Actual)
Sponsor	Norwegian University of Science and Technology (Other); collaborators: St. Olavs Hospital
Conditions	Breast Milk Collection, Overweight and Obesity
Interventions	Moderate intensity exercise, High intensity exercise (Behavioral)
Dates	start 2023-03-01, primary completion 2025-05-20, completion 2025-05-20, first posted 2023-02-27, last updated 2025-09-26
Locations	1 site in Norway

-Summary

The investigators will determine the acute effect of exercise on breastmilk composition. Participants will come in to the lab on three different days, out of which they will exercise on two of these days and rest in the lab on the third day. The conditions will be randomly allocated to each participant. Breastmilk samples will be obtained in the morning of each test day, as well as immediately after, one hour after and four hours after the exercise/rest condition. Dietary intake will be standardized on the test days.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Control	No intervention		Resting in seated position
Moderate intensity exercise	Experimental	Behavioral: Moderate intensity exercise	Moderate intensity endurance exercise, treadmill walking/running at 70% of heart rate maximum for 40 minutes
High intensity exercise	Experimental	Behavioral: High intensity exercise	High intensity interval training: treadmill walking/running. 10 minutes warm-up at 70% of heart rate maximum, followed by four 4-minutes bouts at 90-95% of heart rate maximum, separated by 3-minutes active recovery (at 70% of heart rate maximum)

Moderate intensity exercise (Behavioral): Treadmill walking/running with moderate intensity
High intensity exercise (Behavioral): Treadmill walking/running with high intensity

+Outcome measures

Primary outcomes

Breastmilk metabolite composition [Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)]: Global metabolomics profiling using MS/MS technology

Secondary outcomes

Complex lipids composition [Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)]: Global metabolomics profiling using MS/MS technology
Adiponectin [Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)]: Concentration
Leptin [Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)]: Concentration
Insulin Growth Factor-1 [Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)]: Concentration
Insulin [Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)]: Concentration
Ghrelin [Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)]: Concentration
Cytokine profiling (Multiplex 27) [Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)]: Concentration

Other outcomes

Cardiorespiratory fitness [At baseline]: Peak oxygen uptake
Body mass in kg [At baseline]: Impedance scale
Fat mass in kg [At baseline]: Impedance scale
Muscle mass in kg [At baseline]: Impedance scale
Height in metres [At baseline]: Stadiometer

+Eligibility

Sex: Female, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* 6 weeks postpartum
* Exclusively breastfeeding
* Term birth
* Singleton baby

Exclusion Criteria:

* Known cardiovascular disease
* Known type 1 or type 2 diabetes
* Limited ability to exercise

+Locations (1)

Facility	City	Country	Status
Department of circulation and medical imaging , NTNU	Trondheim	Norway

+Study documents

Study Protocol (PDF, 2025-02-26)
Statistical Analysis Plan (PDF, 2025-09-07)
Informed Consent Form: Partner (PDF, 2024-01-02)
Informed Consent Form: Participant (mother) (PDF, 2024-01-02)