Breastmilk in Response to a Bout of Exercise
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
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.
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);
Trial population
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.
Trial design
Design model
Case-crossover
Time perspective
Cross-sectional
Treatments tested in this trial
Pre-Pregnancy BMI
Other interventionPre-pregnancy BMI between 18.5-24.99
Pre-Pregnancy BMI
Other interventionPre-pregnancy BMI between 25-39.99
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Active1 intervention
Group B: Inactive1 intervention
Trial outcomes
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.
Time frame
1 monthSponsors and contacts
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Source ClinicalTrials.gov