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治験 NCT06892483(対象:乳児の発達、小児肥満、Diabetes, Childhood-onset)は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
Breastmilk in Response to a Bout of Exercise
Breastmilk Composition in Response to a Bout of Exercise
- 24-006207
Postpartum exercise
| 参加グループ/群 | 介入/治療法 |
|---|---|
Active Exercise \> 3 days per week of moderate-intensity exercise | Pre-pregnancy BMI Pre-pregnancy BMI between 18.5-24.99 Pre-pregnancy BMI Pre-pregnancy BMI between 25-39.99 |
Inactive ≤ 1 day per week of exercise | Pre-pregnancy BMI Pre-pregnancy BMI between 18.5-24.99 Pre-pregnancy BMI Pre-pregnancy BMI between 25-39.99 |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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 |
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.
Minnesota