Exercise alters breastmilk – could it protect infants from obesity and diabetes?

NCT ID NCT06892483

Knowledge-focused Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study from Mayo Clinic looks at how one session of exercise changes breastmilk. Researchers will measure tiny particles called exosomes that carry messages between cells. They want to see if exercise boosts these particles in breastmilk, which might help prevent childhood obesity and diabetes. The study includes 60 mothers who are either lean or obese, and either active or inactive.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to: If successful, this could reveal how exercise improves breastmilk, potentially guiding future recommendations for new mothers.
What could go wrong: This is an early observational study with only 60 participants, so results may not apply to all mothers. It looks at short-term changes, not long-term health outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus Pediatric Obesity type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes, childhood-onset Infant development Obesity, childhood

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Exercise alters breastmilk – could it protect infants from obesity and diabetes?

What the study statuses mean