Breastmilk in Response to a Bout of Exercise
Breastmilk Composition in Response to a Bout of Exercise
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2025
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2025
CompletedFirst Posted
Study publicly available on registry
March 24, 2025
CompletedStudy Start
First participant enrolled
April 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 25, 2028
June 24, 2026
June 1, 2026
2.5 years
March 13, 2025
June 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Breastmilk Exosome Concentration
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.
1 month
Study Arms (2)
Active
Exercise \> 3 days per week of moderate-intensity exercise
Inactive
≤ 1 day per week of exercise
Interventions
Eligibility Criteria
Depending upon mode of delivery, it may take up to 6-8 weeks to return to pre-pregnancy physical activity levels, and participants may prefer to have their postpartum visit to receive "medical clearance". Thus, by 2 months after delivery, most participants will have been medically cleared to exercise. Recruitment and screening of participants will take primarily place in the clinical setting either prior to or within 2 months of giving birth. Participants will be consulted throughout the \>2-month period postpartum by an Internationally Board-Certified Lactation Consultant on the study team to increase the likelihood of successful breastfeeding for participants that are recruited prior to giving birth. Half of the participants will be enrolled with a pre-pregnancy BMI between 18.5-24.99 (n=30; normal weight) and the other half will be between 25-39.99 (n=30; obese). The participant's first recorded first-trimester BMI will be used.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Biospecimen
Blood samples and breastmilk will be collected
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Pataky, Ph.D.
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Month
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 13, 2025
First Posted
March 24, 2025
Study Start
April 21, 2025
Primary Completion (Estimated)
October 10, 2027
Study Completion (Estimated)
September 25, 2028
Last Updated
June 24, 2026
Record last verified: 2026-06