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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。
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Breastmilk in Response to a Bout of Exercise

募集中
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます!「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT06892483観察研究 臨床試験 で、乳児の発達、小児肥満、Diabetes, Childhood-onset に関するものです。現在は 募集中 で、2025年4月21日 から開始しています。60 名の参加者 の募集が計画されています。この治験は メイヨー・クリニック によって主催され、2028年9月25日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年5月16日 です。
概要
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.
詳細説明
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.
公式タイトル

Breastmilk Composition in Response to a Bout of Exercise

疾患/病気
乳児の発達小児肥満Diabetes, Childhood-onset
その他の研究識別子
  • 24-006207
NCT番号
開始日
2025-04-21
最終更新日
2025-05-16
終了予定日
2028-09-25
目標参加者数
60
試験の種類
観察研究
状況
募集中
キーワード
Breast milk
Postpartum exercise
群(アーム)/介入
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
主要評価項目
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
適格基準

  • 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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責任者
Mark Pataky, 研究責任者, Principal Investigator, Mayo Clinic
試験中央連絡先
連絡先: Linda Szymanski, M.D., Ph.D., 5072668539, [email protected]
連絡先: Mark Pataky, Ph.D., [email protected]
1 1カ国の場所

Minnesota

Mayo Clinic, Rochester, Minnesota, 55905, United States
Devanshi Gupta, 連絡先, 507-255-6752, [email protected]
Mark W Pataky, Ph. D., M.S., 研究責任者
募集中