Effects of postpartum exercise on breastmilk composition

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.