Breastmilk in Response to a Bout of Exercise
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pre-Pregnancy BMI, Pre-Pregnancy BMI.
- Who it may be relevant to
- Registry conditions: Infant Development, Obesity, Childhood, Diabetes, Childhood-Onset. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Breastmilk Composition in Response to a Bout of Exercise
Overview
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.
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.
Interventions
- Other Pre-Pregnancy BMI
Pre-pregnancy BMI between 18.5-24.99 - Other Pre-Pregnancy BMI
Pre-pregnancy BMI between 25-39.99
Primary outcome measures
- Breastmilk Exosome Concentration [Time frame: 1 month]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-crossover
Study locations
United States · 1 center
- Mayo Clinic — Rochester
Identifiers
NCT: NCT06892483 · 24-006207