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NCT Number: NCT06892483

Breastmilk in Response to a Bout of Exercise

The purpose of this study is to unveil the mechanistic benefits of a bout of postpartum maternal exercise on infant health that are provided by breastmilk.

Recruiting

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Devanshi Gupta

CONTACT

[email protected]

507-255-6752

Mark W Pataky, Ph. D., M.S.

PRINCIPAL_INVESTIGATOR

About this study

The nutrients and antibodies in breastmilk promote infant growth, development, and immunity. Breastfed infants exhibit lower risk of adult-onset obesity and type 2 diabetes compared to formula-fed infants, and the composition of breastmilk is influenced by maternal factors such as obesity and type 2 diabetes, profoundly impacting its health benefits. While postpartum maternal exercise enhances infant health, its effects on breastmilk composition remain unknown, hindering our understanding of how postpartum exercise benefits breastfed infants.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Pre-Pregnancy BMI

Other

Pre-pregnancy BMI between 18.5-24.99

Other names: Lean

Primary outcomes

  1. Breastmilk Exosome Concentration

    Time frame: 1 month

    The molecules in small extracellular vesicles (exosomes) can transmit information between cells throughout the body. A bout of exercise induces a robust release of exosomes in the plasma with unique molecular cargo. Exosomes are also present in breastmilk, and there is evidence that breastmilk exosomes can evade degradation in the infant gut and can thus transmit molecular information from mother to infant. Though maternal exercise is viewed as beneficial for the breastfeeding infant, the molecular mechanisms of how this occurs remain unknown. The primary objective of this trial will be to determine if a bout of maternal exercise increases the release exosomes in breastmilk. The investigators will measure breastmilk exosome concentration using nano particle tracking.

Study contacts

Contact information is provided by the study sponsor or research team.

Linda Szymanski, M.D., Ph.D.

CONTACT

[email protected]

5072668539

Mark Pataky, Ph.D.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Breastmilk Composition in Response to a Bout of Exercise

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Mar 24, 2025
Registry last updated
Jun 24, 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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