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

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.

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

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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