RECRUITING

Breastmilk in Response to a Bout of Exercise

Conditions

Infant Development Obesity, Childhood Diabetes, Childhood-Onset Breast milk Postpartum exercise

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Breastmilk Composition in Response to a Bout of Exercise

Quick Facts

Study Start:2025-04-21

Study Completion:2028-09-25

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06892483

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	* 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.

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

* 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.

Contacts and Locations

Study Contact

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

CONTACT

5072668539

Szymanski.Linda@mayo.edu

Mark Pataky, Ph.D.

CONTACT

Pataky.Mark@mayo.edu

Principal Investigator

Mark Pataky, Ph.D.

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Mark Pataky, Ph.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-21

Study Completion Date2028-09-25

Study Record Updates

Study Start Date2025-04-21

Study Completion Date2028-09-25

Terms related to this study

Keywords Provided by Researchers

Breast milk
Postpartum exercise

Additional Relevant MeSH Terms

Infant Development
Obesity, Childhood
Diabetes, Childhood-Onset