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Active, Not Recruiting

NCT Number: NCT05488964

Effect of Exercise Training 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dept Circulation and Medical Imaging, EXCAR Exercise Lab

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

Supervised endurance training with moderate-to-high intensity 3-4 times weekly.

Primary outcomes

  1. Breastmilk human milk oligosaccharide (HMO) 3'sialyllactose (3'SL)

    Time frame: 0 to 8 weeks

    Relative concentration of 3'SL in breastmilk

Secondary outcomes

  1. Breastmilk human milk oligosaccharide (HMO) 3'sialyllactose (3'SL)

    Time frame: 0 to 4 weeks

    Relative concentration of 3'SL in breastmilk

  2. Breastmilk metabolites

    Time frame: 0 to 8 weeks

    Relative concentrations of metabolites in breastmilk determined using untargeted metabolomics profiling (mass spectrometry)

  3. Breastmilk metabolites

    Time frame: 0 to 4 weeks

    Relative concentrations of metabolites in breastmilk determined using untargeted metabolomics profiling (mass spectrometry)

  4. Breastmilk microRNA

    Time frame: 0 to 8 weeks

    RNA sequencing

  5. Breastmilk microRNA

    Time frame: 0 to 4 weeks

    RNA sequencing

  6. Maternal insulin sensitivity

    Time frame: 0 to 8 weeks

    Homeostatic model assessment of insulin resistance (HOMA-IR)

  7. Maternal fasting circulating insulin C-peptide concentrations

    Time frame: 0 to 8 weeks

    From fasting venous blood sampling

  8. Maternal fasting circulating glucose concentrations

    Time frame: After 9 months from baseline

    From fasting venous blood sampling

  9. Maternal circulating total cholesterol concentrations

    Time frame: 0 to 8 weeks

    From fasting venous blood sampling

  10. Maternal circulating total cholesterol concentrations

    Time frame: After 9 months from baseline

    From fasting venous blood sampling

  11. Maternal circulating high-density lipoprotein (HDL) concentrations

    Time frame: 0 to 8 weeks

    From fasting venous blood sampling

  12. Maternal circulating high-density lipoprotein (HDL) concentrations

    Time frame: After 9 months from baseline

    From fasting venous blood sampling

  13. Maternal circulating low-density lipoprotein (LDL) concentrations

    Time frame: 0 to 8 weeks

    From fasting venous blood sampling

  14. Maternal circulating low-density lipoprotein (LDL) concentrations

    Time frame: After 9 months from baseline

    From fasting venous blood sampling

  15. Maternal circulating triglycerides concentrations

    Time frame: 0 to 8 weeks

    From fasting venous blood sampling

  16. Maternal circulating triglycerides concentrations

    Time frame: After 9 months from baseline

    From fasting venous blood sampling

  17. Maternal glycated hemoglobin (HbA1c)

    Time frame: 0 to 8 weeks

    From fasting venous blood sampling

  18. Maternal glycated hemoglobin (HbA1c)

    Time frame: After 9 months from baseline

    From fasting venous blood sampling

  19. Maternal circulating high-sensitivity c-reactive protein

    Time frame: 0 to 8 weeks

    From fasting venous blood sampling

  20. Maternal circulating high-sensitivity c-reactive protein

    Time frame: After 9 months from baseline

    From fasting venous blood sampling

  21. Maternal total body mass

    Time frame: 0 to 8 weeks

    Impedance scale

  22. Maternal total body mass

    Time frame: After 9 months from baseline

    Impedance scale

  23. Maternal fat mass

    Time frame: 0 to 8 weeks

    Impedance scale

  24. Maternal fat mass

    Time frame: After 9 months from baseline

    Impedance scale

  25. Maternal fat-free mass

    Time frame: 0 to 8 weeks

    Impedance scale

  26. Maternal fat-free mass

    Time frame: After 9 months from baseline

    Impedance scale

  27. Maternal visceral fat area

    Time frame: 0 to 8 weeks

    Impedance scale

  28. Maternal visceral fat area

    Time frame: After 9 months from baseline

    Impedance scale

  29. Maternal bone mass

    Time frame: 0 to 8 weeks

    Impedance scale

  30. Maternal bone mass

    Time frame: After 9 months from baseline

    Impedance scale

  31. Maternal waist circumference

    Time frame: 0 to 8 weeks

    Measuring tape

  32. Maternal waist circumference

    Time frame: After 9 months from baseline

    Measuring tape

  33. Maternal cardiorespiratory fitness

    Time frame: 0 to 8 weeks

    Maximum oxygen uptake via direct gas exchange

  34. Maternal cardiorespiratory fitness

    Time frame: After 9 months from baseline

    Maximum oxygen uptake via direct gas exchange

  35. Maternal systolic blood pressure

    Time frame: 0 to 8 weeks

    Automatic cuff

  36. Maternal systolic blood pressure

    Time frame: After 9 months from baseline

    Automatic cuff

  37. Maternal diastolic blood pressure

    Time frame: 0 to 8 weeks

    Automatic cuff

  38. Maternal diastolic blood pressure

    Time frame: After 9 months from baseline

    Automatic cuff

  39. Maternal nutrition

    Time frame: 0 to 8 weeks

    Diet diary completed for four days at baseline and at study completion

  40. Maternal physical activity

    Time frame: 0 to 8 weeks

    Number of steps per week, self-reported (questionnaire)

  41. Maternal physical activity

    Time frame: After 9 months from baseline

    Number of steps per week, self-reported (questionnaire)

  42. Maternal physical activity

    Time frame: 0 to 8 weeks

    Minutes of moderate-intensity physical activity per week, self-reported (questionnaire)

  43. Maternal physical activity

    Time frame: After 9 months from baseline

    Minutes of high-intensity physical activity per week, self-reported (questionnaire)

  44. Maternal psychological well-being

    Time frame: 0 to 8 weeks

    Self-reported (questionnaire)

  45. Maternal psychological well-being

    Time frame: After 9 months from baseline

    Self-reported (questionnaire)

  46. Infant total body mass

    Time frame: 0 to 8 weeks

    Impedance scale

  47. Infant total body mass

    Time frame: After 9 months from baseline

    Impedance scale

  48. Infant fat mass

    Time frame: 0 to 8 weeks

    Impedance scale

  49. Infant fat mass

    Time frame: After 9 months from baseline

    Impedance scale

  50. Infant muscle mass

    Time frame: 0 to 8 weeks

    Impedance scale

  51. Infant muscle mass

    Time frame: After 9 months from baseline

    Impedance scale

  52. Infant bone density

    Time frame: 0 to 8 weeks

    Impedance scale

  53. Infant bone density

    Time frame: After 9 months from baseline

    Impedance scale

  54. Infant hydration status

    Time frame: 0 to 8 weeks

    Impedance scale

  55. Infant hydration status

    Time frame: After 9 months from baseline

    Impedance scale

  56. Infant total body mass (trajectories)

    Time frame: Infant age 4 weeks

    From health records

  57. Infant length (trajectories)

    Time frame: Infant age 4 weeks

    From health records

  58. Infant head circumference (trajectories)

    Time frame: Infant age 4 weeks

    From health records

  59. Infant total body mass (trajectories)

    Time frame: Infant age 6 weeks

    From health records

  60. Infant length (trajectories)

    Time frame: Infant age 6 weeks

    From health records

  61. Infant head circumference (trajectories)

    Time frame: Infant age 6 weeks

    From health records

  62. Infant total body mass (trajectories)

    Time frame: Infant age 3 months

    From health records

  63. Infant length (trajectories)

    Time frame: Infant age 3 months

    From health records

  64. Infant head circumference (trajectories)

    Time frame: Infant age 3 months

    From health records

  65. Infant total body mass (trajectories)

    Time frame: Infant age 6 months

    From health records

  66. Infant length (trajectories)

    Time frame: Infant age 6 months

    From health records

  67. Infant head circumference (trajectories)

    Time frame: Infant age 6 months

    From health records

  68. Infant total body mass (trajectories)

    Time frame: Infant age 8 months

    From health records

  69. Infant length (trajectories)

    Time frame: Infant age 8 months

    From health records

  70. Infant head circumference (trajectories)

    Time frame: Infant age 8 months

    From health records

  71. Infant total body mass (trajectories)

    Time frame: Infant age 10 months

    From health records

  72. Infant length (trajectories)

    Time frame: Infant age 10 months

    From health records

  73. Infant head circumference (trajectories)

    Time frame: Infant age 10 months

    From health records

  74. Infant total body mass (trajectories)

    Time frame: Infant age 12 months

    From health records

  75. Infant height (trajectories)

    Time frame: Infant age 12 months

    From health records

  76. Infant head circumference (trajectories)

    Time frame: Infant age 12 months

    From health records

  77. Infant total body mass (trajectories)

    Time frame: Infant age 24 months

    From health records

  78. Infant height (trajectories)

    Time frame: Infant age 24 months

    From health records

  79. Infant head circumference (trajectories)

    Time frame: Infant age 24 months

    From health records

  80. Infant gut microbiota

    Time frame: 0 to 4 weeks

    Sequencing

  81. Infant gut microbiota

    Time frame: 0 to 8 weeks

    Sequencing

  82. Infant microRNA

    Time frame: 0 to 8 weeks

    Sequencing

Other outcomes

  1. Exercise adherence

    Time frame: 0 to 8 weeks

    Number of sessions completed (logbook)

  2. Exercise compliance

    Time frame: 0 to 8 weeks

    Heart rate during exercise (heart rate monitor)

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Registry information

Official study title

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

Acronym: MILKSHAKE

Important dates

Study start
2022
Primary completion
2025
Study completion
2028
First posted
Aug 5, 2022
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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