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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Experimental | Regular endurance training for 8 weeks |
|
| Control | No Intervention | Habitual living for 8 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | Supervised endurance training with moderate-to-high intensity 3-4 times weekly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Breastmilk human milk oligosaccharide (HMO) 3'sialyllactose (3'SL) | Relative concentration of 3'SL in breastmilk | 0 to 8 weeks |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise adherence | Number of sessions completed (logbook) | 0 to 8 weeks |
| Exercise compliance | Heart rate during exercise (heart rate monitor) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Trine Moholdt, PhD | Norwegian University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept Circulation and Medical Imaging, EXCAR Exercise Lab | Trondheim | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37829712 | Derived | 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. |
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All IPD that underlie results in a publication
Starting 6 months after publication
IPD will be shared upon requests from researchers. The principal investigator (Trine Moholdt) will review requests.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| 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 |
| 0 to 8 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |