- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05745922
Acute Effects of Endurance Exercise on Breast Milk Composition in Women With Overweight/Obesity (YT)
September 25, 2025 updated by: Norwegian University of Science and Technology
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Trondheim, Norway, 7491
- Department of circulation and medical imaging , NTNU
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 6 weeks postpartum
- Exclusively breastfeeding
- Term birth
- Singleton baby
Exclusion Criteria:
- Known cardiovascular disease
- Known type 1 or type 2 diabetes
- Limited ability to exercise
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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
|
Treadmill walking/running with moderate intensity
|
|
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)
|
Treadmill walking/running with high intensity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Complex lipids composition
Time Frame: Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)
|
Global metabolomics profiling using MS/MS technology
|
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)
|
Concentration
|
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)
|
Concentration
|
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)
|
Concentration
|
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)
|
Concentration
|
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)
|
Concentration
|
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)
|
Concentration
|
Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiorespiratory fitness
Time Frame: At baseline
|
Peak oxygen uptake
|
At baseline
|
|
Body mass in kg
Time Frame: At baseline
|
Impedance scale
|
At baseline
|
|
Fat mass in kg
Time Frame: At baseline
|
Impedance scale
|
At baseline
|
|
Muscle mass in kg
Time Frame: At baseline
|
Impedance scale
|
At baseline
|
|
Height in metres
Time Frame: At baseline
|
Stadiometer
|
At baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2023
Primary Completion (Actual)
May 20, 2025
Study Completion (Actual)
May 20, 2025
Study Registration Dates
First Submitted
February 8, 2023
First Submitted That Met QC Criteria
February 23, 2023
First Posted (Actual)
February 27, 2023
Study Record Updates
Last Update Posted (Estimated)
September 26, 2025
Last Update Submitted That Met QC Criteria
September 25, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nutrition Disorders
- Overnutrition
- Body Weight
- Pathological Conditions, Signs and Symptoms
- Behavior
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Feeding Behavior
- Breast Feeding
- Overweight
- Obesity
- Motor Activity
- Breast Milk Expression
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Physical Conditioning, Human
- Exercise
- High-Intensity Interval Training
Other Study ID Numbers
- 562012
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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