Effects of postpartum exercise on breastmilk composition
Breastmilk Composition in Response to a Bout of Exercise
Mayo Clinic · NCT06892483
This study is testing how a single workout by new mothers affects the nutrients and antibodies in their breastmilk to see if it can help their babies grow healthier.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Mayo Clinic (other) |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06892483 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore how a single bout of exercise by postpartum mothers influences the composition of their breastmilk and, consequently, the health of their infants. It focuses on understanding the relationship between maternal exercise and the nutrients and antibodies present in breastmilk, which are crucial for infant growth and immunity. By examining the impact of maternal factors such as obesity and diabetes on breastmilk, the study seeks to uncover the mechanisms through which postpartum exercise may benefit breastfed infants. The findings could provide insights into optimizing maternal health practices for improved infant outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are postpartum mothers who are not engaged in structured exercise programs and meet specific health criteria.
Not a fit: Patients with active coronary artery disease, heart failure, or those on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of how maternal exercise influences breastmilk composition, potentially leading to better health outcomes for infants.
How similar studies have performed: While the effects of postpartum exercise on breastmilk composition are not extensively studied, related research has shown that maternal health factors significantly influence breastmilk quality.
Eligibility criteria
Show full inclusion / exclusion criteria
Exclusion Criteria:
* Active coronary artery disease or heart failure.
* Participation in a structured exercise program ≥ 1 day/week in the "inactive" subcohort or \< 3 days per week in the "active" subcohort.
* A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
* Abnormal liver function test results (Transaminase \>2 times the upper limit of normal
* Abnormal renal function test results (calculated GFR \<60 mL/min/1.73m2);
* If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study
* Uncontrolled thyroid disease (TSH undetectable or \>10 mlU/L); testing required within three months prior to admission for subjects with a goiter, positive antibodies, or who are on thyroid hormone replacement, and within one year otherwise
* Abuse of alcohol or recreational drugs
* Active tobacco smoking within the past 3 months
* Infectious process not anticipated to resolve prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis).
* Uncontrolled arterial hypertension (Resting diastolic blood pressure \>90 mmHg and/or systolic blood pressure \>160 mmHg) at the time of screening.
* A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol
* Active pregnancy
* Restrictions on Use of Other Drugs or Treatments:
* Any other medication believed to be a contraindication to the subject's participation.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Mark Pataky, Ph.D. — Mayo Clinic
- Study coordinator: Linda Szymanski, M.D., Ph.D.
- Email: Szymanski.Linda@mayo.edu
- Phone: 5072668539
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.
Conditions: Infant Development, Obesity, Childhood, Diabetes, Childhood-Onset, Breast milk, Postpartum exercise