Breastmilk in Response to a Bout of Exercise

Breastmilk Composition 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.

Study Overview

• Status: Recruiting
• Conditions: Obesity, Childhood; Infant Development; Diabetes, Childhood-Onset
• Intervention / Treatment: Other: Pre-Pregnancy BMI; Other: Pre-Pregnancy BMI

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Linda Szymanski, M.D., Ph.D.; Phone Number: 5072668539; Email: Szymanski.Linda@mayo.edu
• Study Contact Backup: Name: Mark Pataky, Ph.D.; Email: Pataky.Mark@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Contact: Devanshi Gupta; Phone Number: 507-255-6752; Email: Gupta.Devanshi@mayo.edu
      • Principal Investigator: Mark W Pataky, Ph. D., M.S.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Active; Exercise > 3 days per week of moderate-intensity exercise	Other: Pre-Pregnancy BMI; Pre-pregnancy BMI between 18.5-24.99; Other Names: Lean; Other: Pre-Pregnancy BMI; Pre-pregnancy BMI between 25-39.99; Other Names: Obese
Inactive; ≤ 1 day per week of exercise	Other: Pre-Pregnancy BMI; Pre-pregnancy BMI between 18.5-24.99; Other Names: Lean; Other: Pre-Pregnancy BMI; Pre-pregnancy BMI between 25-39.99; Other Names: Obese

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Mark Pataky, Ph.D., Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2025
• Primary Completion (Estimated): October 10, 2027
• Study Completion (Estimated): September 25, 2028

Study Registration Dates

• First Submitted: March 13, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 24, 2025

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 15, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Breast milk; Postpartum exercise
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 24-006207

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No