Acute Effects of Endurance Exercise on Breastmilk Composition (ExMilk)

October 7, 2022 updated by: Norwegian University of Science and Technology

Acute Effects of Endurance Exercise on Breastmilk Composition: Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

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

  • Norway
      • Trondheim, Norway
        • 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

No

Genders Eligible for Study

Female

Description

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

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: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Breastmilk
Randomized intervention order.
Behavioral: High intensity interval training
Four times four minutes treadmill interval training
Behavioral: Moderate intensity training
Moderate intensity treadmill training
Behavioral: Resting
No training

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)
Metabolomics profiling
Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adiponectin
Time Frame: Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)
Concentration in breastmilk
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 in breastmilk
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 in breastmilk
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 in breastmilk
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 in breastmilk
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
Height in metres
Time Frame: At baseline
stadiometer
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital

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)

August 24, 2021

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

August 13, 2021

First Submitted That Met QC Criteria

September 4, 2021

First Posted (Actual)

September 13, 2021

Study Record Updates

Last Update Posted (Actual)

October 10, 2022

Last Update Submitted That Met QC Criteria

October 7, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 263493

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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