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| Name | Class |
|---|---|
| St. Olavs Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderate intensity exercise | Behavioral | Treadmill walking/running with moderate intensity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Breastmilk metabolite composition | Global metabolomics profiling using MS/MS technology | Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Complex lipids composition | Global metabolomics profiling using MS/MS technology | Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours) |
| Adiponectin | Concentration |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiorespiratory fitness | Peak oxygen uptake | At baseline |
| Body mass in kg | Impedance scale | At baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of circulation and medical imaging , NTNU | Trondheim | 7491 | Norway |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 26, 2025 | Sep 8, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 7, 2025 | Sep 8, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Partner | Jan 2, 2024 | Sep 23, 2025 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Participant (mother) | Jan 2, 2024 | Sep 23, 2025 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D061186 | Breast Milk Expression |
| D050177 | Overweight |
| D009765 | Obesity |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D044343 | Overnutrition |
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| ID | Term |
|---|---|
| D000072696 | High-Intensity Interval Training |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
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Sequential assignment
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The personnel who will be analysing the milk samples will be blinded to which condition the samples were obtained from and the time-point.
| High intensity exercise | Behavioral | Treadmill walking/running with high intensity |
|
| Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours) |
| Leptin | Concentration | Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours) |
| Insulin Growth Factor-1 | Concentration | Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours) |
| Insulin | Concentration | Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours) |
| Ghrelin | Concentration | Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours) |
| Cytokine profiling (Multiplex 27) | Concentration | Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours) |
| Fat mass in kg | Impedance scale | At baseline |
| Muscle mass in kg | Impedance scale | At baseline |
| Height in metres | Stadiometer | At baseline |
| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |