BreastmilkExMilkNCT05042414
Acute Effects of Endurance Exercise on Breastmilk Composition
A study testing High intensity interval training, Moderate intensity training and Resting in people with Breastmilk, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastmilk
- What is being tested?
- High intensity interval training, Moderate intensity training and Resting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- 24 Aug 2021to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 6 to 12 weeks postpartum
- Exclusive breastfeeding
- Term birth
Who cannot join
- Known cardiovascular disease
- Type 1 or 2 diabetes mellitus
- Limited ability to exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effects of Endurance Exercise on Breastmilk Composition: Pilot Study
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.
- Conditions
- Breastmilk
- Being tested
- High intensity interval training, Moderate intensity training, Resting
- Keywords
- Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity interval trainingBehavioural
Four times four minutes treadmill interval training
Moderate intensity trainingBehavioural
Moderate intensity treadmill training
RestingBehavioural
No training
| Study group | Role | What they receive |
|---|---|---|
| Breastmilk | Experimental | Randomized intervention order. Receives: Behavioral: High intensity interval training; Behavioral: Moderate intensity training; Behavioral: Resting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastmilk metabolite composition
Metabolomics profiling
Measured: Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)
Secondary outcomes (5)
Adiponectin
Concentration in breastmilk
Measured: Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)
Leptin
Concentration in breastmilk
Measured: Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)
Insulin
Concentration in breastmilk
Measured: Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)
Insulin Growth Factor-1
Concentration in breastmilk
Measured: Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)
Cytokine profiling (Multiplex 27)
Concentration in breastmilk
Measured: Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start24 Aug 2021
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BreastmilkStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Øystein Risa, Phd, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042414
- Sponsor's protocol ID
- 263493
- Acronym
- ExMilk
- Status last verified
- Oct 2022
- First submitted
- 13 Aug 2021
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lemoine MCC, Klau LJ, Holmen M, Ashby ER, Aachmann FL, Andreassen T, Giskeodegard GF, Moholdt T. Unaltered 3'-sialyllactose and 6'-sialyllactose concentrations in human milk acutely after endurance exercise: a randomized crossover trial. Front Nutr. 2025 Oct 27;12:1638430. doi: 10.3389/fnut.2025.1638430. eCollection 2025.
PubMed 41220705Holm RL, Holmen M, Sujan MAJ, Giskeodegard GF, Moholdt T. Acute effect of endurance exercise on human milk insulin concentrations: a randomised cross-over study. Front Nutr. 2025 Jan 27;11:1507156. doi: 10.3389/fnut.2024.1507156. eCollection 2024.
PubMed 39981021
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Endurance Exercise on Breastmilk Composition: Pilot Study
- ClinicalTrials.gov ID
- NCT05042414
- Acronym / sponsor ID
- ExMilk / 263493
- Conditions
- Breastmilk
- Keywords
- Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- 24 Aug 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 13 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breastmilk | Experimental | Behavioral: High intensity interval training, Behavioral: Moderate intensity training, Behavioral: RestingRandomized intervention order. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 6 to 12 weeks postpartum
- Exclusive breastfeeding
- Term birth
Key exclusion criteria (3 listed)
- Known cardiovascular disease
- Type 1 or 2 diabetes mellitus
- Limited ability to exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High intensity interval trainingFour times four minutes treadmill interval training | Behavioural | Breastmilk |
| Moderate intensity trainingModerate intensity treadmill training | Behavioural | Breastmilk |
| RestingNo training | Behavioural | Breastmilk |
Primary outcome
Breastmilk metabolite composition
Time frame: Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)
Metabolomics profiling
5 secondary outcomes
Adiponectin
Time frame: Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)
Leptin
Time frame: Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)
Insulin
Time frame: Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)
Insulin Growth Factor-1
Time frame: Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)
Cytokine profiling (Multiplex 27)
Time frame: Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Derived from this study: PubMed 41220705Lemoine MCC, Klau LJ, Holmen M, Ashby ER, Aachmann FL, Andreassen T, Giskeodegard GF, Moholdt T. Unaltered 3'-sialyllactose and 6'-sialyllactose concentrations in human milk acutely after endurance exercise: a randomized crossover trial. Front Nutr. 2025 Oct 27;12:1638430. doi: 10.3389/fnut.2025.1638430. eCollection 2025.
- Derived from this study: PubMed 39981021Holm RL, Holmen M, Sujan MAJ, Giskeodegard GF, Moholdt T. Acute effect of endurance exercise on human milk insulin concentrations: a randomised cross-over study. Front Nutr. 2025 Jan 27;11:1507156. doi: 10.3389/fnut.2024.1507156. eCollection 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Øystein Risa, Phd study director
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity interval training, Moderate intensity training and Resting in people with Breastmilk, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastmilk metabolite composition (time frame: Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05042414, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022.