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Search / Trial NCT06892483

Breastmilk in Response to a Bout of Exercise

Launched by MAYO CLINIC · Mar 20, 2025

Trial Information

Current as of April 29, 2025

Recruiting

Keywords

Breast Milk Postpartum Exercise

ClinConnect Summary

This clinical trial is exploring how exercise by new mothers might affect the health benefits passed to their infants through breastmilk. The researchers want to understand how a single session of exercise after giving birth can improve the quality of breastmilk and, in turn, support infant development and potentially help prevent obesity and diabetes in childhood.

To participate in this study, women aged between 18 and 45 who are new mothers will be eligible, but they must not have certain health conditions, such as heart disease, active pregnancy, or any serious medical issues that could interfere with the study. Participants can expect to engage in a brief exercise session, and researchers will then analyze their breastmilk to see if there are any positive changes. This study aims to provide valuable insights into how maternal health and activity can impact the health of their babies.

Gender

FEMALE

Eligibility 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.

About Mayo Clinic

Mayo Clinic is a renowned nonprofit medical practice and research institution dedicated to providing comprehensive healthcare and advancing medical knowledge through innovative research and education. With a commitment to patient-centered care, Mayo Clinic conducts numerous clinical trials aimed at exploring new therapies and improving treatment outcomes across various disciplines. Leveraging a multidisciplinary approach, the institution collaborates with leading experts and cutting-edge technology to ensure rigorous scientific standards and ethical practices in all its research endeavors. Through its trials, Mayo Clinic seeks to translate breakthroughs in science into tangible benefits for patients, fostering advancements in medicine that enhance health and quality of life.

Locations

Rochester, Minnesota, United States

Patients applied

0 patients applied

Trial Officials

Mark Pataky, Ph.D.

Principal Investigator

Mayo Clinic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported