Effect of Exercise Training on Breastmilk Composition (MILKSHAKE)

April 7, 2026 updated by: Norwegian University of Science and Technology

Exercised Breastmilk: A Randomised Controlled Trial on the Effect of Exercise Training During Lactation on Breastmilk Composition

The aim of this trial is to investigate whether regular endurance exercise during the lactation period will influence breastmilk composition among individuals with overweight/obesity, and secondarily to assess if such changes impact the growth and health of the infants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Norway
      • Trondheim, Norway
        • Dept Circulation and Medical Imaging, EXCAR Exercise Lab

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female
  • Aged 18 years or older
  • Body mass index ≥ 25 kg/m2 pre-pregnancy and/or BMI ≥ 28 kg/m2 postpartum
  • Given birth to a singleton term (after 37 weeks + 0 days) baby
  • 6-7 weeks postpartum at time of inclusion
  • Exclusively breastfeeding the baby (no other foods are given) and intend to continue this practice for ≥ 8 weeks at inclusion
  • Understands oral and written Norwegian

Exclusion Criteria:

  • On-going pregnancy
  • Known type 1 or type 2 diabetes
  • Known cardiovascular disease
  • High intensity exercise more than twice weekly the last three months before inclusion and/or an intention to start regular endurance training within the next 8 weeks at baseline

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exercise
Regular endurance training for 8 weeks
Behavioral: Exercise
Supervised endurance training with moderate-to-high intensity 3-4 times weekly.
No Intervention: Control
Habitual living for 8 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Breastmilk human milk oligosaccharide (HMO) 3'sialyllactose (3'SL)
Time Frame: 0 to 8 weeks
Relative concentration of 3'SL in breastmilk
0 to 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Breastmilk human milk oligosaccharide (HMO) 3'sialyllactose (3'SL)
Time Frame: 0 to 4 weeks
Relative concentration of 3'SL in breastmilk
0 to 4 weeks
Breastmilk metabolites
Time Frame: 0 to 8 weeks
Relative concentrations of metabolites in breastmilk determined using untargeted metabolomics profiling (mass spectrometry)
0 to 8 weeks
Breastmilk metabolites
Time Frame: 0 to 4 weeks
Relative concentrations of metabolites in breastmilk determined using untargeted metabolomics profiling (mass spectrometry)
0 to 4 weeks
Breastmilk microRNA
Time Frame: 0 to 8 weeks
RNA sequencing
0 to 8 weeks
Breastmilk microRNA
Time Frame: 0 to 4 weeks
RNA sequencing
0 to 4 weeks
Maternal insulin sensitivity
Time Frame: 0 to 8 weeks
Homeostatic model assessment of insulin resistance (HOMA-IR)
0 to 8 weeks
Maternal fasting circulating insulin C-peptide concentrations
Time Frame: 0 to 8 weeks
From fasting venous blood sampling
0 to 8 weeks
Maternal circulating total cholesterol concentrations
Time Frame: 0 to 8 weeks
From fasting venous blood sampling
0 to 8 weeks
Maternal circulating high-density lipoprotein (HDL) concentrations
Time Frame: 0 to 8 weeks
From fasting venous blood sampling
0 to 8 weeks
Maternal circulating low-density lipoprotein (LDL) concentrations
Time Frame: 0 to 8 weeks
From fasting venous blood sampling
0 to 8 weeks
Maternal circulating triglycerides concentrations
Time Frame: 0 to 8 weeks
From fasting venous blood sampling
0 to 8 weeks
Maternal glycated hemoglobin (HbA1c)
Time Frame: 0 to 8 weeks
From fasting venous blood sampling
0 to 8 weeks
Maternal circulating high-sensitivity c-reactive protein
Time Frame: 0 to 8 weeks
From fasting venous blood sampling
0 to 8 weeks
Maternal total body mass
Time Frame: 0 to 8 weeks
Impedance scale
0 to 8 weeks
Maternal fat mass
Time Frame: 0 to 8 weeks
Impedance scale
0 to 8 weeks
Maternal fat-free mass
Time Frame: 0 to 8 weeks
Impedance scale
0 to 8 weeks
Maternal visceral fat area
Time Frame: 0 to 8 weeks
Impedance scale
0 to 8 weeks
Maternal waist circumference
Time Frame: 0 to 8 weeks
Measuring tape
0 to 8 weeks
Maternal cardiorespiratory fitness
Time Frame: 0 to 8 weeks
Maximum oxygen uptake via direct gas exchange
0 to 8 weeks
Maternal systolic blood pressure
Time Frame: 0 to 8 weeks
Automatic cuff
0 to 8 weeks
Maternal diastolic blood pressure
Time Frame: 0 to 8 weeks
Automatic cuff
0 to 8 weeks
Maternal nutrition
Time Frame: 0 to 8 weeks
Diet diary completed for four days at baseline and at study completion
0 to 8 weeks
Maternal physical activity
Time Frame: 0 to 8 weeks
Number of steps per week, self-reported (questionnaire)
0 to 8 weeks
Maternal physical activity
Time Frame: 0 to 8 weeks
Minutes of moderate-intensity physical activity per week, self-reported (questionnaire)
0 to 8 weeks
Maternal psychological well-being
Time Frame: 0 to 8 weeks
Self-reported (questionnaire)
0 to 8 weeks
Infant total body mass
Time Frame: 0 to 8 weeks
Impedance scale
0 to 8 weeks
Infant fat mass
Time Frame: 0 to 8 weeks
Impedance scale
0 to 8 weeks
Infant muscle mass
Time Frame: 0 to 8 weeks
Impedance scale
0 to 8 weeks
Infant bone density
Time Frame: 0 to 8 weeks
Impedance scale
0 to 8 weeks
Infant hydration status
Time Frame: 0 to 8 weeks
Impedance scale
0 to 8 weeks
Infant total body mass (trajectories)
Time Frame: Infant age 4 weeks
From health records
Infant age 4 weeks
Infant length (trajectories)
Time Frame: Infant age 4 weeks
From health records
Infant age 4 weeks
Infant head circumference (trajectories)
Time Frame: Infant age 4 weeks
From health records
Infant age 4 weeks
Infant total body mass (trajectories)
Time Frame: Infant age 6 weeks
From health records
Infant age 6 weeks
Infant length (trajectories)
Time Frame: Infant age 6 weeks
From health records
Infant age 6 weeks
Infant head circumference (trajectories)
Time Frame: Infant age 6 weeks
From health records
Infant age 6 weeks
Infant total body mass (trajectories)
Time Frame: Infant age 3 months
From health records
Infant age 3 months
Infant length (trajectories)
Time Frame: Infant age 3 months
From health records
Infant age 3 months
Infant head circumference (trajectories)
Time Frame: Infant age 3 months
From health records
Infant age 3 months
Infant total body mass (trajectories)
Time Frame: Infant age 6 months
From health records
Infant age 6 months
Infant length (trajectories)
Time Frame: Infant age 6 months
From health records
Infant age 6 months
Infant head circumference (trajectories)
Time Frame: Infant age 6 months
From health records
Infant age 6 months
Infant total body mass (trajectories)
Time Frame: Infant age 8 months
From health records
Infant age 8 months
Infant length (trajectories)
Time Frame: Infant age 8 months
From health records
Infant age 8 months
Infant head circumference (trajectories)
Time Frame: Infant age 8 months
From health records
Infant age 8 months
Infant total body mass (trajectories)
Time Frame: Infant age 10 months
From health records
Infant age 10 months
Infant length (trajectories)
Time Frame: Infant age 10 months
From health records
Infant age 10 months
Infant head circumference (trajectories)
Time Frame: Infant age 10 months
From health records
Infant age 10 months
Infant total body mass (trajectories)
Time Frame: Infant age 12 months
From health records
Infant age 12 months
Infant height (trajectories)
Time Frame: Infant age 12 months
From health records
Infant age 12 months
Infant head circumference (trajectories)
Time Frame: Infant age 12 months
From health records
Infant age 12 months
Infant total body mass (trajectories)
Time Frame: Infant age 24 months
From health records
Infant age 24 months
Infant height (trajectories)
Time Frame: Infant age 24 months
From health records
Infant age 24 months
Infant head circumference (trajectories)
Time Frame: Infant age 24 months
From health records
Infant age 24 months
Infant gut microbiota
Time Frame: 0 to 4 weeks
Sequencing
0 to 4 weeks
Infant gut microbiota
Time Frame: 0 to 8 weeks
Sequencing
0 to 8 weeks
Infant microRNA
Time Frame: 0 to 8 weeks
Sequencing
0 to 8 weeks
Maternal fasting circulating glucose concentrations
Time Frame: After 9 months from baseline
From fasting venous blood sampling
After 9 months from baseline
Maternal circulating total cholesterol concentrations
Time Frame: After 9 months from baseline
From fasting venous blood sampling
After 9 months from baseline
Maternal circulating high-density lipoprotein (HDL) concentrations
Time Frame: After 9 months from baseline
From fasting venous blood sampling
After 9 months from baseline
Maternal circulating low-density lipoprotein (LDL) concentrations
Time Frame: After 9 months from baseline
From fasting venous blood sampling
After 9 months from baseline
Maternal circulating triglycerides concentrations
Time Frame: After 9 months from baseline
From fasting venous blood sampling
After 9 months from baseline
Maternal glycated hemoglobin (HbA1c)
Time Frame: After 9 months from baseline
From fasting venous blood sampling
After 9 months from baseline
Maternal circulating high-sensitivity c-reactive protein
Time Frame: After 9 months from baseline
From fasting venous blood sampling
After 9 months from baseline
Maternal fat-free mass
Time Frame: After 9 months from baseline
Impedance scale
After 9 months from baseline
Maternal visceral fat area
Time Frame: After 9 months from baseline
Impedance scale
After 9 months from baseline
Maternal waist circumference
Time Frame: After 9 months from baseline
Measuring tape
After 9 months from baseline
Maternal cardiorespiratory fitness
Time Frame: After 9 months from baseline
Maximum oxygen uptake via direct gas exchange
After 9 months from baseline
Maternal systolic blood pressure
Time Frame: After 9 months from baseline
Automatic cuff
After 9 months from baseline
Maternal diastolic blood pressure
Time Frame: After 9 months from baseline
Automatic cuff
After 9 months from baseline
Maternal physical activity
Time Frame: After 9 months from baseline
Number of steps per week, self-reported (questionnaire)
After 9 months from baseline
Maternal physical activity
Time Frame: After 9 months from baseline
Minutes of high-intensity physical activity per week, self-reported (questionnaire)
After 9 months from baseline
Maternal psychological well-being
Time Frame: After 9 months from baseline
Self-reported (questionnaire)
After 9 months from baseline
Infant total body mass
Time Frame: After 9 months from baseline
Impedance scale
After 9 months from baseline
Infant fat mass
Time Frame: After 9 months from baseline
Impedance scale
After 9 months from baseline
Infant muscle mass
Time Frame: After 9 months from baseline
Impedance scale
After 9 months from baseline
Infant bone density
Time Frame: After 9 months from baseline
Impedance scale
After 9 months from baseline
Infant hydration status
Time Frame: After 9 months from baseline
Impedance scale
After 9 months from baseline
Maternal total body mass
Time Frame: After 9 months from baseline
Impedance scale
After 9 months from baseline
Maternal fat mass
Time Frame: After 9 months from baseline
Impedance scale
After 9 months from baseline
Maternal bone mass
Time Frame: 0 to 8 weeks
Impedance scale
0 to 8 weeks
Maternal bone mass
Time Frame: After 9 months from baseline
Impedance scale
After 9 months from baseline

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Exercise adherence
Time Frame: 0 to 8 weeks
Number of sessions completed (logbook)
0 to 8 weeks
Exercise compliance
Time Frame: 0 to 8 weeks
Heart rate during exercise (heart rate monitor)
0 to 8 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Norwegian University of Science and Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Trine Moholdt, PhD, Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 24, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 479236

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication

IPD Sharing Time Frame

Starting 6 months after publication

IPD Sharing Access Criteria

IPD will be shared upon requests from researchers. The principal investigator (Trine Moholdt) will review requests.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

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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