Breast Milk CollectionYTNCT05745922
Acute Effects of Endurance Exercise on Breast Milk Composition in Women With Overweight/Obesity
A study testing Moderate intensity exercise and High intensity exercise in people with Breast Milk Collection and Overweight and Obesity, 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
- Breast Milk Collection, Overweight and Obesity
- What is being tested?
- Moderate intensity exercise and High intensity exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteNorway
- Study dates
- 1 Mar 2023to 20 May 2025
- 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 weeks postpartum
- Exclusively breastfeeding
- Term birth
- Singleton baby
Who cannot join
- Known cardiovascular disease
- Known type 1 or type 2 diabetes
- Limited ability to exercise
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of circulation and medical imaging , NTNU
Trondheim, 7491
About this study
Official title: Acute Effects of Endurance Exercise With Moderate and High Intensity on Breast Milk Composition Among Women With Overweight/Obesity
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.
- Conditions
- Breast Milk Collection, Overweight and Obesity
- Being tested
- Moderate intensity exercise, High intensity exercise
- Keywords
- Exercise
- Medical subject headings
- Breast Milk Expression, Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate intensity exerciseBehavioural
Treadmill walking/running with moderate intensity
High intensity exerciseBehavioural
Treadmill walking/running with high intensity
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Resting in seated position |
| Moderate intensity exercise | Experimental | Moderate intensity endurance exercise, treadmill walking/running at 70% of heart rate maximum for 40 minutes Receives: Behavioral: Moderate intensity exercise |
| High intensity exercise | Experimental | 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) Receives: Behavioral: High intensity exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastmilk metabolite composition
Global metabolomics profiling using MS/MS technology
Measured: Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)
Secondary outcomes (7)
Complex lipids composition
Global metabolomics profiling using MS/MS technology
Measured: Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)
Adiponectin
Concentration
Measured: Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)
Leptin
Concentration
Measured: Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)
Insulin Growth Factor-1
Concentration
Measured: Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)
Insulin
Concentration
Measured: Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)
Ghrelin
Concentration
Measured: Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)
Cytokine profiling (Multiplex 27)
Concentration
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 posted27 Feb 2023
- Study start1 Mar 2023
- Primary completion20 May 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Milk CollectionStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- Sequential assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745922
- Sponsor's protocol ID
- 562012
- Acronym
- YT
- Status last verified
- Sep 2025
- First submitted
- 8 Feb 2023
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Endurance Exercise With Moderate and High Intensity on Breast Milk Composition Among Women With Overweight/Obesity
- ClinicalTrials.gov ID
- NCT05745922
- Acronym / sponsor ID
- YT / 562012
- Conditions
- Breast Milk Collection, Overweight and Obesity
- Keywords
- Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 27 Feb 2023 (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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Sequential assignment
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Resting in seated position |
| Moderate intensity exercise | Experimental | Behavioral: Moderate intensity exerciseModerate intensity endurance exercise, treadmill walking/running at 70% of heart rate maximum for 40 minutes |
| High intensity exercise | Experimental | Behavioral: High intensity exerciseHigh 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 6 weeks postpartum
- Exclusively breastfeeding
- Term birth
- Singleton baby
Key exclusion criteria (3 listed)
- Known cardiovascular disease
- Known type 1 or type 2 diabetes
- 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 |
|---|---|---|
| Moderate intensity exerciseTreadmill walking/running with moderate intensity | Behavioural | Moderate intensity exercise |
| High intensity exerciseTreadmill walking/running with high intensity | Behavioural | High intensity exercise |
Primary outcome
Breastmilk metabolite composition
Time frame: Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)
Global metabolomics profiling using MS/MS technology
7 secondary outcomes
Complex lipids composition
Time frame: Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)
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 Growth Factor-1
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)
Ghrelin
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 26 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate intensity exercise and High intensity exercise in people with Breast Milk Collection and Overweight and Obesity, 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 4 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 26 Sep 2025. 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?
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 26 Sep 2025.