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Completed

NCT Number: NCT05042414

Acute Effects of Endurance Exercise on Breastmilk Composition

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. At the time of study commencement, the trial (including planned analyses) is not fully funded. Additional milk will be stored for future analyses (not yet specified) when funding is secured.

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Key information

Conditions

Breastmilk Behavior Motor Activity

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, Norway

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 6 to 12 weeks postpartum
  • Exclusive breastfeeding
  • Term birth

Exclusion criteria

  • Known cardiovascular disease
  • Type 1 or 2 diabetes mellitus
  • Limited ability to exercise

Treatment and study plan

High Intensity Interval Training

Behavioral

Four times four minutes treadmill interval training

Moderate Intensity Training

Behavioral

Moderate intensity treadmill training

Resting

Behavioral

No training

Primary outcomes

  1. Breastmilk metabolite composition

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

    Metabolomics profiling

Secondary outcomes

  1. Adiponectin

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

    Concentration in breastmilk

  2. Leptin

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

    Concentration in breastmilk

  3. Insulin

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

    Concentration in breastmilk

  4. Insulin Growth Factor-1

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

    Concentration in breastmilk

  5. Cytokine profiling (Multiplex 27)

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

    Concentration in breastmilk

Other outcomes

  1. Cardiorespiratory fitness

    Time frame: At baseline

    Peak oxygen uptake

  2. Body mass in kg

    Time frame: At baseline

    Impedance scale

  3. Height in metres

    Time frame: At baseline

    stadiometer

  4. Fat mass in kg

    Time frame: At baseline

    Impedance scale

  5. Muscle mass in kg

    Time frame: At baseline

    Impedance scale

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 on Breastmilk Composition: Pilot Study

Acronym: ExMilk

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 13, 2021
Registry last updated
Oct 10, 2022

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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