ObesityMILKSHAKENCT05488964
Effect of Exercise Training on Breastmilk Composition
A study testing Exercise in people with Obesity, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteNorway
- Study dates
- 1 Sep 2022to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site
Dept Circulation and Medical Imaging, EXCAR Exercise Lab
Trondheim
About this study
Official title: 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.
- Conditions
- Obesity
- Being tested
- Exercise
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Supervised endurance training with moderate-to-high intensity 3-4 times weekly.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Regular endurance training for 8 weeks Receives: Behavioral: Exercise |
| Control | No intervention | Habitual living for 8 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastmilk human milk oligosaccharide (HMO) 3'sialyllactose (3'SL)
Relative concentration of 3'SL in breastmilk
Measured: 0 to 8 weeks
Secondary outcomes (84)
Breastmilk human milk oligosaccharide (HMO) 3'sialyllactose (3'SL)
Relative concentration of 3'SL in breastmilk
Measured: 0 to 4 weeks
Breastmilk metabolites
Relative concentrations of metabolites in breastmilk determined using untargeted metabolomics profiling (mass spectrometry)
Measured: 0 to 8 weeks
Breastmilk metabolites
Relative concentrations of metabolites in breastmilk determined using untargeted metabolomics profiling (mass spectrometry)
Measured: 0 to 4 weeks
Breastmilk microRNA
RNA sequencing
Measured: 0 to 8 weeks
Breastmilk microRNA
RNA sequencing
Measured: 0 to 4 weeks
Maternal insulin sensitivity
Homeostatic model assessment of insulin resistance (HOMA-IR)
Measured: 0 to 8 weeks
Maternal fasting circulating insulin C-peptide concentrations
From fasting venous blood sampling
Measured: 0 to 8 weeks
Maternal fasting circulating glucose concentrations
From fasting venous blood sampling
Measured: 6 months after completion of the 8-week intervention period
Maternal circulating total cholesterol concentrations
From fasting venous blood sampling
Measured: 0 to 8 weeks
Maternal circulating total cholesterol concentrations
From fasting venous blood sampling
Measured: 6 months after completion of the 8-week intervention period
Maternal circulating high-density lipoprotein (HDL) concentrations
From fasting venous blood sampling
Measured: 0 to 8 weeks
Maternal circulating high-density lipoprotein (HDL) concentrations
From fasting venous blood sampling
Measured: 6 months after completion of the 8-week intervention period
Maternal circulating low-density lipoprotein (LDL) concentrations
From fasting venous blood sampling
Measured: 0 to 8 weeks
Maternal circulating low-density lipoprotein (LDL) concentrations
From fasting venous blood sampling
Measured: 6 months after completion of the 8-week intervention period
Maternal circulating triglycerides concentrations
From fasting venous blood sampling
Measured: 0 to 8 weeks
Maternal circulating triglycerides concentrations
From fasting venous blood sampling
Measured: 6 months after completion of the 8-week intervention period
Maternal glycated hemoglobin (HbA1c)
From fasting venous blood sampling
Measured: 0 to 8 weeks
Maternal glycated hemoglobin (HbA1c)
From fasting venous blood sampling
Measured: 6 months after completion of the 8-week intervention period
Maternal circulating high-sensitivity c-reactive protein
From fasting venous blood sampling
Measured: 0 to 8 weeks
Maternal circulating high-sensitivity c-reactive protein
From fasting venous blood sampling
Measured: 6 months after completion of the 8-week intervention period
Maternal total body mass
Impedance scale
Measured: 0 to 8 weeks
Maternal total body mass
Impedance scale
Measured: 6 months after completion of the 8-week intervention period
Maternal fat mass
Impedance scale
Measured: 0 to 8 weeks
Maternal fat mass
Impedance scale
Measured: 6 months after completion of the 8-week intervention period
Maternal fat-free mass
Impedance scale
Measured: 0 to 8 weeks
Maternal fat-free mass
Impedance scale
Measured: 6 months after completion of the 8-week intervention period
Maternal visceral fat area
Impedance scale
Measured: 0 to 8 weeks
Maternal visceral fat area
Impedance scale
Measured: 6 months after completion of the 8-week intervention period
Maternal bone mass
Impedance scale
Measured: 0 to 8 weeks
Maternal bone mass
Impedance scale
Measured: 6 months after completion of the 8-week intervention period
Maternal waist circumference
Measuring tape
Measured: 0 to 8 weeks
Maternal waist circumference
Measuring tape
Measured: 6 months after completion of the 8-week intervention period
Maternal cardiorespiratory fitness
Maximum oxygen uptake via direct gas exchange
Measured: 0 to 8 weeks
Maternal cardiorespiratory fitness
Maximum oxygen uptake via direct gas exchange
Measured: 6 months after completion of the 8-week intervention period
Maternal systolic blood pressure
Automatic cuff
Measured: 0 to 8 weeks
Maternal systolic blood pressure
Automatic cuff
Measured: 6 months after completion of the 8-week intervention period
Maternal diastolic blood pressure
Automatic cuff
Measured: 0 to 8 weeks
Maternal diastolic blood pressure
Automatic cuff
Measured: 6 months after completion of the 8-week intervention period
Maternal nutrition
Diet diary completed for four days at baseline and at study completion
Measured: 0 to 8 weeks
Maternal physical activity
Number of steps per week, self-reported (questionnaire)
Measured: 0 to 8 weeks
Maternal physical activity
Number of steps per week, self-reported (questionnaire)
Measured: 6 months after completion of the 8-week intervention period
Maternal physical activity
Minutes of moderate-intensity physical activity per week, self-reported (questionnaire)
Measured: 0 to 8 weeks
Maternal physical activity
Minutes of high-intensity physical activity per week, self-reported (questionnaire)
Measured: 6 months after completion of the 8-week intervention period
Maternal psychological well-being
Self-reported (questionnaire)
Measured: 0 to 8 weeks
Maternal psychological well-being
Self-reported (questionnaire)
Measured: 6 months after completion of the 8-week intervention period
Infant total body mass
Impedance scale
Measured: 0 to 8 weeks
Infant total body mass
Impedance scale
Measured: 6 months after completion of the 8-week intervention period
Infant fat mass
Impedance scale
Measured: 0 to 8 weeks
Infant fat mass
Impedance scale
Measured: 6 months after completion of the 8-week intervention period
Infant muscle mass
Impedance scale
Measured: 0 to 8 weeks
Infant muscle mass
Impedance scale
Measured: 6 months after completion of the 8-week intervention period
Infant bone density
Impedance scale
Measured: 0 to 8 weeks
Infant bone density
Impedance scale
Measured: 6 months after completion of the 8-week intervention period
Infant hydration status
Impedance scale
Measured: 0 to 8 weeks
Infant hydration status
Impedance scale
Measured: 6 months after completion of the 8-week intervention period
Infant total body mass (trajectories)
From health records
Measured: Infant age 4 weeks
Infant length (trajectories)
From health records
Measured: Infant age 4 weeks
Infant head circumference (trajectories)
From health records
Measured: Infant age 4 weeks
Infant total body mass (trajectories)
From health records
Measured: Infant age 6 weeks
Infant length (trajectories)
From health records
Measured: Infant age 6 weeks
Infant head circumference (trajectories)
From health records
Measured: Infant age 6 weeks
Infant total body mass (trajectories)
From health records
Measured: Infant age 3 months
Infant length (trajectories)
From health records
Measured: Infant age 3 months
Infant head circumference (trajectories)
From health records
Measured: Infant age 3 months
Infant total body mass (trajectories)
From health records
Measured: Infant age 6 months
Infant length (trajectories)
From health records
Measured: Infant age 6 months
Infant head circumference (trajectories)
From health records
Measured: Infant age 6 months
Infant total body mass (trajectories)
From health records
Measured: Infant age 8 months
Infant length (trajectories)
From health records
Measured: Infant age 8 months
Infant head circumference (trajectories)
From health records
Measured: Infant age 8 months
Infant total body mass (trajectories)
From health records
Measured: Infant age 10 months
Infant length (trajectories)
From health records
Measured: Infant age 10 months
Infant head circumference (trajectories)
From health records
Measured: Infant age 10 months
Infant total body mass (trajectories)
From health records
Measured: Infant age 12 months
Infant height (trajectories)
From health records
Measured: Infant age 12 months
Infant head circumference (trajectories)
From health records
Measured: Infant age 12 months
Infant total body mass (trajectories)
From health records
Measured: Infant age 24 months
Infant height (trajectories)
From health records
Measured: Infant age 24 months
Infant head circumference (trajectories)
From health records
Measured: Infant age 24 months
Infant gut microbiota
Sequencing
Measured: 0 to 4 weeks
Infant gut microbiota
Sequencing
Measured: 0 to 8 weeks
Infant microRNA
Sequencing
Measured: 0 to 8 weeks
Maternal serum human milk oligosaccharides (HMOs)
Concentrations of HMOs in maternal serum measured by mass spectrometry
Measured: 0 to 8 weeks
Infant faecal short-chain fatty acids (SCFAs)
Concentrations of short-chain fatty acids in infant faecal samples measured by gas chromatography-mass spectrometry.
Measured: Baseline to 24 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start1 Sep 2022
- Primary completion24 Nov 2025
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Trine Moholdt, PhD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488964
- Sponsor's protocol ID
- 479236
- Acronym
- MILKSHAKE
- Status last verified
- Oct 2026
- First submitted
- 6 Jul 2022
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
Moholdt T, Ashby ER, Tommerdal KH, Lemoine MCC, Holm RL, Saetrom P, Iversen AC, Ravi A, Simpson MR, Giskeodegard GF. Randomised controlled trial of exercise training during lactation on breast milk composition in breastfeeding people with overweight/obesity: a study protocol for the MILKSHAKE trial. BMJ Open Sport Exerc Med. 2023 Oct 6;9(4):e001751. doi: 10.1136/bmjsem-2023-001751. eCollection 2023.
PubMed 37829712
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercised Breastmilk: A Randomised Controlled Trial on the Effect of Exercise Training During Lactation on Breastmilk Composition
- ClinicalTrials.gov ID
- NCT05488964
- Acronym / sponsor ID
- MILKSHAKE / 479236
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 24 Nov 2025 (actual)
- Study completion
- Mar 2028 (estimated)
- First posted
- 5 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExerciseRegular endurance training for 8 weeks |
| Control | No intervention | –Habitual living for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseSupervised endurance training with moderate-to-high intensity 3-4 times weekly. | Behavioural | Exercise |
Primary outcome
Breastmilk human milk oligosaccharide (HMO) 3'sialyllactose (3'SL)
Time frame: 0 to 8 weeks
Relative concentration of 3'SL in breastmilk
84 secondary outcomes
Breastmilk human milk oligosaccharide (HMO) 3'sialyllactose (3'SL)
Time frame: 0 to 4 weeks
Breastmilk metabolites
Time frame: 0 to 8 weeks
Breastmilk metabolites
Time frame: 0 to 4 weeks
Breastmilk microRNA
Time frame: 0 to 8 weeks
Breastmilk microRNA
Time frame: 0 to 4 weeks
Maternal insulin sensitivity
Time frame: 0 to 8 weeks
Maternal fasting circulating insulin C-peptide concentrations
Time frame: 0 to 8 weeks
Maternal fasting circulating glucose concentrations
Time frame: 6 months after completion of the 8-week intervention period
Maternal circulating total cholesterol concentrations
Time frame: 0 to 8 weeks
Maternal circulating total cholesterol concentrations
Time frame: 6 months after completion of the 8-week intervention period
Maternal circulating high-density lipoprotein (HDL) concentrations
Time frame: 0 to 8 weeks
Maternal circulating high-density lipoprotein (HDL) concentrations
Time frame: 6 months after completion of the 8-week intervention period
Maternal circulating low-density lipoprotein (LDL) concentrations
Time frame: 0 to 8 weeks
Maternal circulating low-density lipoprotein (LDL) concentrations
Time frame: 6 months after completion of the 8-week intervention period
Maternal circulating triglycerides concentrations
Time frame: 0 to 8 weeks
Maternal circulating triglycerides concentrations
Time frame: 6 months after completion of the 8-week intervention period
Maternal glycated hemoglobin (HbA1c)
Time frame: 0 to 8 weeks
Maternal glycated hemoglobin (HbA1c)
Time frame: 6 months after completion of the 8-week intervention period
Maternal circulating high-sensitivity c-reactive protein
Time frame: 0 to 8 weeks
Maternal circulating high-sensitivity c-reactive protein
Time frame: 6 months after completion of the 8-week intervention period
Maternal total body mass
Time frame: 0 to 8 weeks
Maternal total body mass
Time frame: 6 months after completion of the 8-week intervention period
Maternal fat mass
Time frame: 0 to 8 weeks
Maternal fat mass
Time frame: 6 months after completion of the 8-week intervention period
Maternal fat-free mass
Time frame: 0 to 8 weeks
Maternal fat-free mass
Time frame: 6 months after completion of the 8-week intervention period
Maternal visceral fat area
Time frame: 0 to 8 weeks
Maternal visceral fat area
Time frame: 6 months after completion of the 8-week intervention period
Maternal bone mass
Time frame: 0 to 8 weeks
Maternal bone mass
Time frame: 6 months after completion of the 8-week intervention period
Maternal waist circumference
Time frame: 0 to 8 weeks
Maternal waist circumference
Time frame: 6 months after completion of the 8-week intervention period
Maternal cardiorespiratory fitness
Time frame: 0 to 8 weeks
Maternal cardiorespiratory fitness
Time frame: 6 months after completion of the 8-week intervention period
Maternal systolic blood pressure
Time frame: 0 to 8 weeks
Maternal systolic blood pressure
Time frame: 6 months after completion of the 8-week intervention period
Maternal diastolic blood pressure
Time frame: 0 to 8 weeks
Maternal diastolic blood pressure
Time frame: 6 months after completion of the 8-week intervention period
Maternal nutrition
Time frame: 0 to 8 weeks
Maternal physical activity
Time frame: 0 to 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Derived from this study: PubMed 37829712Moholdt T, Ashby ER, Tommerdal KH, Lemoine MCC, Holm RL, Saetrom P, Iversen AC, Ravi A, Simpson MR, Giskeodegard GF. Randomised controlled trial of exercise training during lactation on breast milk composition in breastfeeding people with overweight/obesity: a study protocol for the MILKSHAKE trial. BMJ Open Sport Exerc Med. 2023 Oct 6;9(4):e001751. doi: 10.1136/bmjsem-2023-001751. eCollection 2023.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trine Moholdt, PhD principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Obesity, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastmilk human milk oligosaccharide (HMO) 3'sialyllactose (3'SL) (time frame: 0 to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05488964, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.