Recruiting

Postpartum Exercise

Sponsor:

Mayo Clinic

Code:

NCT06892483

Conditions

Infant Development

Obesity, Childhood

Diabetes, Childhood-Onset

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Pre-Pregnancy BMI

Pre-Pregnancy BMI

Study Details

Brief summary:

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.

Conditions

Infant Development

Obesity, Childhood

Diabetes, Childhood-Onset

Study ID

NCT06892483

Start date

Apr 21, 2025

Status verified date

Jun, 2026

Completion date

Sep 25, 2028

Anticipated

Primary completion date

Oct 10, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Active

Exercise > 3 days per week of moderate-intensity exercise

Inactive

≤ 1 day per week of exercise

Interventions

Pre-Pregnancy BMI

Pre-pregnancy BMI between 18.5-24.99

Pre-Pregnancy BMI

Pre-pregnancy BMI between 25-39.99

Primary outcome measure

  • Breastmilk Exosome Concentration [ Time Frame: 1 month ]

Central Contacts and Locations

Central contacts

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

5072668539Szymanski.Linda@mayo.edu

Mark Pataky, Ph.D.

Pataky.Mark@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Devanshi Gupta

507-255-6752Gupta.Devanshi@mayo.edu

Principal Investigator:

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

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 24, 2026

Last verified

Jun, 2026

Keywords

  • Breast milk
  • Postpartum exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-24.