Effect of Exercise Training on Breastmilk Composition

Obesity Clinical Trial

— MILKSHAKE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05488964
• Other study ID #: 479236
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: March 1, 2026

Study information

• Verified date: August 2023
• Source: Norwegian University of Science and Technology
• Contact: Trine Moholdt, PhD
• Phone: +4797098594
• Email: trine.moholdt[@]ntnu.no
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Exercise
Supervised endurance training with moderate-to-high intensity 3-4 times weekly.

Locations

Country	Name	City	State
Norway	Dept Circulation and Medical Imaging, EXCAR Exercise Lab	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

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