ClinicalTrials.gg
CompletedNCT05745922YTUpdated Sep 26, 2025

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

An interventional study of Moderate intensity exercise and High intensity exercise in Breast Milk Collection and Overweight and Obesity, sponsored by Norwegian University of Science and Technology. Completed at 1 site in Norway. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-26.

Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Milk Collection
  • Overweight and Obesity

Keywords

  • Exercise
03

In context

Breast Milk Expression

88 studies on the registry are indexed under Breast Milk Expression; 20 are open to participants now.

This study's enrollment of 32 is below the median of 60 across 49 interventional studies indexed under Breast Milk Expression.

Browse Breast Milk Expression studies →

Lead sponsor

Norwegian University of Science and Technology is the lead sponsor of 495 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Known cardiovascular disease
  • Known type 1 or type 2 diabetes
  • Limited ability to exercise
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
32 participants (actual)

Study arms

  • No intervention
    Control

    Resting in seated position

  • Experimental
    Moderate intensity exercise

    Moderate intensity endurance exercise, treadmill walking/running at 70% of heart rate maximum for 40 minutes

    Behavioral: Moderate intensity exercise

  • Experimental
    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)

    Behavioral: High intensity exercise

Interventions

  • BehavioralModerate intensity exercise

    Treadmill walking/running with moderate intensity

  • BehavioralHigh intensity exercise

    Treadmill walking/running with high intensity

06

What researchers measure

Primary outcomes

  1. Breastmilk metabolite composition

    Global metabolomics profiling using MS/MS technology

    Time frame: Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)

Secondary outcomes

  1. Complex lipids composition

    Global metabolomics profiling using MS/MS technology

    Time frame: Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)

  2. Adiponectin

    Concentration

    Time frame: Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)

  3. Leptin

    Concentration

    Time frame: Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)

  4. Insulin Growth Factor-1

    Concentration

    Time frame: Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)

  5. Insulin

    Concentration

    Time frame: Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)

  6. Ghrelin

    Concentration

    Time frame: Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)

  7. Cytokine profiling (Multiplex 27)

    Concentration

    Time frame: Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)

Other outcomes

  1. Cardiorespiratory fitness

    Peak oxygen uptake

    Time frame: At baseline

  2. Body mass in kg

    Impedance scale

    Time frame: At baseline

  3. Fat mass in kg

    Impedance scale

    Time frame: At baseline

  4. Muscle mass in kg

    Impedance scale

    Time frame: At baseline

  5. Height in metres

    Stadiometer

    Time frame: At baseline

07

Study locations

1 site
  • Department of circulation and medical imaging , NTNU
    Trondheim, 7491, Norway
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2023 to primary completion in May 2025, 26 months.

Of 32 non-industry interventional studies with no phase under Breast Milk Expression, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 28. This study's 26 months is above that.

Counting every sponsor, half of 39 studies reached it within 13 months; a quarter within 5 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 8, 2023
First posted
Feb 27, 2023
StartActual
Mar 1, 2023
Primary completionActual
May 20, 2025
CompletionActual
May 20, 2025
Last update
Sep 26, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05745922
Collaborators
St. Olavs Hospital
Responsible party
Sponsor
First posted
Feb 27, 2023
Start date
Mar 1, 2023
Primary completion
May 20, 2025
Completion
May 20, 2025
Last update
Sep 26, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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