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Acute Effects of Endurance Exercise on Breastmilk Composition

Acute Effects of Endurance Exercise on Breastmilk Composition: Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05042414
Acronym
ExMilk
Enrollment
20
Registered
2021-09-13
Start date
2021-08-24
Completion date
2022-06-01
Last updated
2022-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastmilk

Keywords

Exercise

Brief 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. At the time of study commencement, the trial (including planned analyses) is not fully funded. Additional milk will be stored for future analyses (not yet specified) when funding is secured.

Interventions

BEHAVIORALHigh intensity interval training

Four times four minutes treadmill interval training

Moderate intensity treadmill training

BEHAVIORALResting

No training

Sponsors

St. Olavs Hospital
CollaboratorOTHER
Norwegian University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 6 to 12 weeks postpartum * Exclusive breastfeeding * Term birth

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Breastmilk metabolite compositionChange from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)Metabolomics profiling

Secondary

MeasureTime frameDescription
AdiponectinChange from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)Concentration in breastmilk
LeptinChange from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)Concentration in breastmilk
InsulinChange from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)Concentration in breastmilk
Insulin Growth Factor-1Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)Concentration in breastmilk
Cytokine profiling (Multiplex 27)Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)Concentration in breastmilk

Other

MeasureTime frameDescription
Body mass in kgAt baselineImpedance scale
Height in metresAt baselinestadiometer
Fat mass in kgAt baselineImpedance scale
Muscle mass in kgAt baselineImpedance scale
Cardiorespiratory fitnessAt baselinePeak oxygen uptake

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026