Investigating how exercise affects breastmilk composition in overweight women
Exercised Breastmilk: A Randomised Controlled Trial on the Effect of Exercise Training During Lactation on Breastmilk Composition
This study is testing how regular exercise affects the breastmilk of overweight women who are breastfeeding to see if it helps their babies grow healthier.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Norwegian University of Science and Technology Academic / other |
| Locations | 1 site (Trondheim) |
| Trial ID | NCT05488964 on ClinicalTrials.gov |
What this trial studies
This trial aims to explore the impact of regular endurance exercise on the composition of breastmilk in women who are overweight or obese during the lactation period. Participants will engage in a structured exercise program while exclusively breastfeeding their infants. The study will also assess whether changes in breastmilk composition influence the growth and health of the infants. The research is conducted by the Norwegian University of Science and Technology in Trondheim.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 or older with a BMI of 25 or higher before pregnancy or 28 or higher postpartum, who are exclusively breastfeeding and intend to continue for at least 8 weeks.
Not a fit: Patients who are pregnant, have diabetes, cardiovascular disease, or engage in high-intensity exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved breastmilk quality, benefiting both mothers and their infants.
How similar studies have performed: While there is limited research specifically on exercise and breastmilk composition, similar studies on lifestyle interventions during lactation have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Trondheim
- Dept Circulation and Medical Imaging, EXCAR Exercise Lab — Trondheim, Norway (Recruiting)
Study contacts
- Principal investigator: Trine Moholdt, PhD — Norwegian University of Science and Technology
- Study coordinator: Trine Moholdt, PhD
- Email: trine.moholdt@ntnu.no
- Phone: +4797098594
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.