Effect of Exercise Training on Breastmilk Composition

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>Regular endurance training for 8 weeks | Behavioral: Exercise<br>* Supervised endurance training with moderate-to-high intensity 3-4 times weekly.<br>|
| No Intervention: Control<br>Habitual living for 8 weeks | |

What is the study measuring?
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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 fasting circulating glucose concentrations | From fasting venous blood sampling | After 9 months from baseline | 
| Maternal circulating total cholesterol concentrations | From fasting venous blood sampling | 0 to 8 weeks | 
| 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 | 0 to 8 weeks | 
| 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 | 0 to 8 weeks | 
| 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 | 0 to 8 weeks | 
| Maternal circulating triglycerides concentrations | From fasting venous blood sampling | After 9 months from baseline | 
| Maternal glycated hemoglobin (HbA1c) | From fasting venous blood sampling | 0 to 8 weeks | 
| 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 | 0 to 8 weeks | 
| Maternal circulating high-sensitivity c-reactive protein | From fasting venous blood sampling | After 9 months from baseline | 
| Maternal total body mass | Impedance scale | 0 to 8 weeks | 
| Maternal total body mass | Impedance scale | After 9 months from baseline | 
| Maternal fat mass | Impedance scale | 0 to 8 weeks | 
| Maternal fat mass | Impedance scale | After 9 months from baseline | 
| Maternal fat-free mass | Impedance scale | 0 to 8 weeks | 
| Maternal fat-free mass | Impedance scale | After 9 months from baseline | 
| Maternal visceral fat area | Impedance scale | 0 to 8 weeks | 
| Maternal visceral fat area | 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 | 
| Maternal waist circumference | Measuring tape | 0 to 8 weeks | 
| Maternal waist circumference | Measuring tape | After 9 months from baseline | 
| Maternal cardiorespiratory fitness | Maximum oxygen uptake via direct gas exchange | 0 to 8 weeks | 
| Maternal cardiorespiratory fitness | Maximum oxygen uptake via direct gas exchange | After 9 months from baseline | 
| Maternal systolic blood pressure | Automatic cuff | 0 to 8 weeks | 
| Maternal systolic blood pressure | Automatic cuff | After 9 months from baseline | 
| Maternal diastolic blood pressure | Automatic cuff | 0 to 8 weeks | 
| Maternal diastolic blood pressure | Automatic cuff | After 9 months from baseline | 
| 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 | Number of steps per week, self-reported (questionnaire) | After 9 months from baseline | 
| Maternal physical activity | Minutes of moderate-intensity physical activity per week, self-reported (questionnaire) | 0 to 8 weeks | 
| 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) | 0 to 8 weeks | 
| Maternal psychological well-being | Self-reported (questionnaire) | After 9 months from baseline | 
| Infant total body mass | Impedance scale | 0 to 8 weeks | 
| Infant total body mass | Impedance scale | After 9 months from baseline | 
| Infant fat mass | Impedance scale | 0 to 8 weeks | 
| Infant fat mass | Impedance scale | After 9 months from baseline | 
| Infant muscle mass | Impedance scale | 0 to 8 weeks | 
| Infant muscle mass | Impedance scale | After 9 months from baseline | 
| Infant bone density | Impedance scale | 0 to 8 weeks | 
| Infant bone density | Impedance scale | After 9 months from baseline | 
| Infant hydration status | Impedance scale | 0 to 8 weeks | 
| Infant hydration status | Impedance scale | After 9 months from baseline | 
| 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 |