Effect of Exercise Training on Breastmilk Composition (MILKSHAKE)

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: Active, not recruiting
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Exercise

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Breastmilk human milk oligosaccharide (HMO) 3'sialyllactose (3'SL)	Relative concentration of 3'SL in breastmilk	0 to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breastmilk human milk oligosaccharide (HMO) 3'sialyllactose (3'SL)	Relative concentration of 3'SL in breastmilk	0 to 4 weeks
Breastmilk metabolites	Relative concentrations of metabolites in breastmilk determined using untargeted metabolomics profiling (mass spectrometry)	0 to 8 weeks
Breastmilk metabolites	Relative concentrations of metabolites in breastmilk determined using untargeted metabolomics profiling (mass spectrometry)	0 to 4 weeks
Breastmilk microRNA	RNA sequencing	0 to 8 weeks
Breastmilk microRNA	RNA sequencing	0 to 4 weeks
Maternal insulin sensitivity	Homeostatic model assessment of insulin resistance (HOMA-IR)	0 to 8 weeks
Maternal fasting circulating insulin C-peptide concentrations	From fasting venous blood sampling	0 to 8 weeks
Maternal circulating total cholesterol concentrations	From fasting venous blood sampling	0 to 8 weeks
Maternal circulating high-density lipoprotein (HDL) concentrations	From fasting venous blood sampling	0 to 8 weeks
Maternal circulating low-density lipoprotein (LDL) concentrations	From fasting venous blood sampling	0 to 8 weeks
Maternal circulating triglycerides concentrations	From fasting venous blood sampling	0 to 8 weeks
Maternal glycated hemoglobin (HbA1c)	From fasting venous blood sampling	0 to 8 weeks
Maternal circulating high-sensitivity c-reactive protein	From fasting venous blood sampling	0 to 8 weeks
Maternal total body mass	Impedance scale	0 to 8 weeks
Maternal fat mass	Impedance scale	0 to 8 weeks
Maternal fat-free mass	Impedance scale	0 to 8 weeks
Maternal visceral fat area	Impedance scale	0 to 8 weeks
Maternal waist circumference	Measuring tape	0 to 8 weeks
Maternal cardiorespiratory fitness	Maximum oxygen uptake via direct gas exchange	0 to 8 weeks
Maternal systolic blood pressure	Automatic cuff	0 to 8 weeks
Maternal diastolic blood pressure	Automatic cuff	0 to 8 weeks
Maternal nutrition	Diet diary completed for four days at baseline and at study completion	0 to 8 weeks
Maternal physical activity	Number of steps per week, self-reported (questionnaire)	0 to 8 weeks
Maternal physical activity	Minutes of moderate-intensity physical activity per week, self-reported (questionnaire)	0 to 8 weeks
Maternal psychological well-being	Self-reported (questionnaire)	0 to 8 weeks
Infant total body mass	Impedance scale	0 to 8 weeks
Infant fat mass	Impedance scale	0 to 8 weeks
Infant muscle mass	Impedance scale	0 to 8 weeks
Infant bone density	Impedance scale	0 to 8 weeks
Infant hydration status	Impedance scale	0 to 8 weeks
Infant total body mass (trajectories)	From health records	Infant age 4 weeks
Infant length (trajectories)	From health records	Infant age 4 weeks
Infant head circumference (trajectories)	From health records	Infant age 4 weeks
Infant total body mass (trajectories)	From health records	Infant age 6 weeks
Infant length (trajectories)	From health records	Infant age 6 weeks
Infant head circumference (trajectories)	From health records	Infant age 6 weeks
Infant total body mass (trajectories)	From health records	Infant age 3 months
Infant length (trajectories)	From health records	Infant age 3 months
Infant head circumference (trajectories)	From health records	Infant age 3 months
Infant total body mass (trajectories)	From health records	Infant age 6 months
Infant length (trajectories)	From health records	Infant age 6 months
Infant head circumference (trajectories)	From health records	Infant age 6 months
Infant total body mass (trajectories)	From health records	Infant age 8 months
Infant length (trajectories)	From health records	Infant age 8 months
Infant head circumference (trajectories)	From health records	Infant age 8 months
Infant total body mass (trajectories)	From health records	Infant age 10 months
Infant length (trajectories)	From health records	Infant age 10 months
Infant head circumference (trajectories)	From health records	Infant age 10 months
Infant total body mass (trajectories)	From health records	Infant age 12 months
Infant height (trajectories)	From health records	Infant age 12 months
Infant head circumference (trajectories)	From health records	Infant age 12 months
Infant total body mass (trajectories)	From health records	Infant age 24 months
Infant height (trajectories)	From health records	Infant age 24 months
Infant head circumference (trajectories)	From health records	Infant age 24 months
Infant gut microbiota	Sequencing	0 to 4 weeks
Infant gut microbiota	Sequencing	0 to 8 weeks
Infant microRNA	Sequencing	0 to 8 weeks
Maternal fasting circulating glucose concentrations	From fasting venous blood sampling	After 9 months from baseline
Maternal circulating total cholesterol concentrations	From fasting venous blood sampling	After 9 months from baseline
Maternal circulating high-density lipoprotein (HDL) concentrations	From fasting venous blood sampling	After 9 months from baseline
Maternal circulating low-density lipoprotein (LDL) concentrations	From fasting venous blood sampling	After 9 months from baseline
Maternal circulating triglycerides concentrations	From fasting venous blood sampling	After 9 months from baseline
Maternal glycated hemoglobin (HbA1c)	From fasting venous blood sampling	After 9 months from baseline
Maternal circulating high-sensitivity c-reactive protein	From fasting venous blood sampling	After 9 months from baseline
Maternal fat-free mass	Impedance scale	After 9 months from baseline
Maternal visceral fat area	Impedance scale	After 9 months from baseline
Maternal waist circumference	Measuring tape	After 9 months from baseline
Maternal cardiorespiratory fitness	Maximum oxygen uptake via direct gas exchange	After 9 months from baseline
Maternal systolic blood pressure	Automatic cuff	After 9 months from baseline
Maternal diastolic blood pressure	Automatic cuff	After 9 months from baseline
Maternal physical activity	Number of steps per week, self-reported (questionnaire)	After 9 months from baseline
Maternal physical activity	Minutes of high-intensity physical activity per week, self-reported (questionnaire)	After 9 months from baseline
Maternal psychological well-being	Self-reported (questionnaire)	After 9 months from baseline
Infant total body mass	Impedance scale	After 9 months from baseline
Infant fat mass	Impedance scale	After 9 months from baseline
Infant muscle mass	Impedance scale	After 9 months from baseline
Infant bone density	Impedance scale	After 9 months from baseline
Infant hydration status	Impedance scale	After 9 months from baseline
Maternal total body mass	Impedance scale	After 9 months from baseline
Maternal fat mass	Impedance scale	After 9 months from baseline
Maternal bone mass	Impedance scale	0 to 8 weeks
Maternal bone mass	Impedance scale	After 9 months from baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise adherence	Number of sessions completed (logbook)	0 to 8 weeks
Exercise compliance	Heart rate during exercise (heart rate monitor)	0 to 8 weeks

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Investigators: Principal Investigator: Trine Moholdt, PhD, Norwegian University of Science and Technology

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): November 24, 2025
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: July 6, 2022
• First Submitted That Met QC Criteria: August 3, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID 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