Obesity
Conditions
Brief 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.
Interventions
BEHAVIORALExercise
Supervised endurance training with moderate-to-high intensity 3-4 times weekly.
Sponsors
Norwegian University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breastmilk human milk oligosaccharide (HMO) 3'sialyllactose (3'SL) | 0 to 8 weeks | Relative concentration of 3'SL in breastmilk |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breastmilk human milk oligosaccharide (HMO) 3'sialyllactose (3'SL) | 0 to 4 weeks | Relative concentration of 3'SL in breastmilk |
| Breastmilk metabolites | 0 to 8 weeks | Relative concentrations of metabolites in breastmilk determined using untargeted metabolomics profiling (mass spectrometry) |
| Breastmilk microRNA | 0 to 8 weeks | RNA sequencing |
| Maternal insulin sensitivity | 0 to 8 weeks | Homeostatic model assessment of insulin resistance (HOMA-IR) |
| Maternal fasting circulating insulin C-peptide concentrations | 0 to 8 weeks | From fasting venous blood sampling |
| Maternal fasting circulating glucose concentrations | After 9 months from baseline | From fasting venous blood sampling |
| Maternal circulating total cholesterol concentrations | 0 to 8 weeks | From fasting venous blood sampling |
| Maternal circulating high-density lipoprotein (HDL) concentrations | 0 to 8 weeks | From fasting venous blood sampling |
| Maternal circulating low-density lipoprotein (LDL) concentrations | 0 to 8 weeks | From fasting venous blood sampling |
| Maternal circulating triglycerides concentrations | 0 to 8 weeks | From fasting venous blood sampling |
| Maternal glycated hemoglobin (HbA1c) | 0 to 8 weeks | From fasting venous blood sampling |
| Maternal circulating high-sensitivity c-reactive protein | 0 to 8 weeks | From fasting venous blood sampling |
| Maternal total body mass | 0 to 8 weeks | Impedance scale |
| Maternal fat mass | 0 to 8 weeks | Impedance scale |
| Maternal fat-free mass | 0 to 8 weeks | Impedance scale |
| Maternal visceral fat area | 0 to 8 weeks | Impedance scale |
| Maternal bone mass | 0 to 8 weeks | Impedance scale |
| Maternal waist circumference | 0 to 8 weeks | Measuring tape |
| Maternal cardiorespiratory fitness | 0 to 8 weeks | Maximum oxygen uptake via direct gas exchange |
| Maternal systolic blood pressure | 0 to 8 weeks | Automatic cuff |
| Maternal diastolic blood pressure | 0 to 8 weeks | Automatic cuff |
| Maternal nutrition | 0 to 8 weeks | Diet diary completed for four days at baseline and at study completion |
| Maternal physical activity | 0 to 8 weeks | Number of steps per week, self-reported (questionnaire) |
| Maternal psychological well-being | 0 to 8 weeks | Self-reported (questionnaire) |
| Infant total body mass | 0 to 8 weeks | Impedance scale |
| Infant fat mass | 0 to 8 weeks | Impedance scale |
| Infant muscle mass | 0 to 8 weeks | Impedance scale |
| Infant bone density | 0 to 8 weeks | Impedance scale |
| Infant hydration status | 0 to 8 weeks | Impedance scale |
| Infant total body mass (trajectories) | Infant age 4 weeks | From health records |
| Infant length (trajectories) | Infant age 4 weeks | From health records |
| Infant head circumference (trajectories) | Infant age 4 weeks | From health records |
| Infant height (trajectories) | Infant age 12 months | From health records |
| Infant gut microbiota | 0 to 4 weeks | Sequencing |
| Infant microRNA | 0 to 8 weeks | Sequencing |
Countries
Norway
Contacts
PRINCIPAL_INVESTIGATORTrine Moholdt, PhD
Norwegian University of Science and Technology
Outcome results
None listed