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OpenTrials
Completed

NCT Number: NCT05745922

Acute Effects of Endurance Exercise on Breast Milk Composition in 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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of circulation and medical imaging , NTNU

Trondheim, 7491, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moderate Intensity Exercise

Behavioral

Treadmill walking/running with moderate intensity

High intensity exercise

Behavioral

Treadmill walking/running with high intensity

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Adiponectin

    Time frame: Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)

    Concentration

  3. Leptin

    Time frame: Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)

    Concentration

  4. Insulin Growth Factor-1

    Time frame: Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)

    Concentration

  5. Insulin

    Time frame: Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)

    Concentration

  6. Ghrelin

    Time frame: Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)

    Concentration

  7. Cytokine profiling (Multiplex 27)

    Time frame: Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)

    Concentration

Other outcomes

  1. Cardiorespiratory fitness

    Time frame: At baseline

    Peak oxygen uptake

  2. Body mass in kg

    Time frame: At baseline

    Impedance scale

  3. Fat mass in kg

    Time frame: At baseline

    Impedance scale

  4. Muscle mass in kg

    Time frame: At baseline

    Impedance scale

  5. Height in metres

    Time frame: At baseline

    Stadiometer

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Official study title

Acute Effects of Endurance Exercise With Moderate and High Intensity on Breast Milk Composition Among Women With Overweight/Obesity

Acronym: YT

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 27, 2023
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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