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Идёт набор NCT07258576

Menstrual Cycle vs. Oral Contraceptives: Effects on Muscle Protein Metabolism After Resistance Exercise

Без фазы С лечением Female Sex Hormones Menstrual Cycle Oral Contraceptives Protein Metabolism

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Protein Beverage, Stable Isotope Tracer [D5]phenylalanine, Stable Isotope Tracer [13C]phenylalanine.
Кому может быть актуально
Состояния в реестре: Female Sex Hormones, Menstrual Cycle, Oral Contraceptives, Protein Metabolism. Базовые параметры: 18 лет — 40 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
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Официальное название

The Effect of Menstrual Cycle Phase and Oral Contraceptive Use on Muscle Protein Metabolism Post-Resistance Training

Обзор

The muscles of the body are constantly breaking down old proteins and building new ones. These two processes, protein breakdown and protein synthesis, together are known as protein turnover. Protein turnover is essential for maintaining healthy muscle. Despite its importance, females have historically been underrepresented in protein metabolism research. A long-standing assumption has been that fluctuations in female sex hormones such as estrogen and progesterone, whether across the natural menstrual cycle or in individuals using oral contraceptives (OCs), make metabolism and training responses too variable to study. Because of this, many researchers have excluded female participants for logistical reasons. Resistance exercise, such as weightlifting, is the most effective way to increase muscle size and strength. Each resistance-training session triggers muscle protein synthesis (MPS), the process by which new muscle proteins are built. Consuming dietary protein or individual amino acids further increases the rate at which new proteins are formed. Over time, higher rates of protein synthesis support muscle growth and the maintenance of other lean tissues in the body. The purpose of this study is to examine how menstrual cycle phases and OC use influence the synthesis of proteins in both muscle tissue and the rest of the body. Improving scientific understanding in this area will support more effective, evidence-based training and nutrition recommendations for females.

Вмешательства

  • Пищевая добавка Protein Beverage
    Participants will consume 16 half-hourly (8 hours) isoenergetic, isonitrogenous beverages containing 1.2 g/kg/d protein.
  • Пищевая добавка Stable Isotope Tracer [D5]phenylalanine
    Protein beverages will be enriched with the stable isotope \[D5\]phenylalanine. The use of \[D5\]phenylalanine will allow for determination of muscle protein synthesis.
  • Пищевая добавка Stable Isotope Tracer [13C]phenylalanine
    Protein beverages will be enriched with the stable isotope tracer \[13C\]phenylalanine. The use of \[13C\]phenylalanine will allow for the determination of the fate of amino acids in the body (incorporation into body protein or oxidation) which can be used to determine protein requirements.

Первичные конечные точки

  • Muscle Protein Synthesis (MPS) [Срок оценки: 8 hours]
Вторичные конечные точки (1)
  • Whole Body Protein Synthesis (WBPS) [Срок оценки: 4 hours]

Критерии участия

Критерии включения

  • Age: 18-40 years
  • BMI between 18.5-29.9 kg/m2 (non-obese)
  • Recreationally active (resistance train minimum twice a week)
  • Using monophasic or triphasic oral contraceptives for >1 year (for oral contraceptive users)
  • Have regular menstrual cycles (21-35 days) for the past 3 months and discontinued any hormonal contraceptive use for at least 6 months (non-oral contraceptive users)
  • Must meet a progesterone sufficiency test (non-oral contraceptive users)

Критерии исключения

  • Mid-luteal progesterone levels <16umol
  • Chronic disease diagnosis (cardiovascular, thyroid, diabetes)
  • Current or recent remission of cancer
  • Regular use of non-steroidal anti-inflammatory drugs (NSAIDs; except low-dose aspirin), anticoagulants
  • Use of prescription drugs that would impact muscle protein synthesis, e.g. Statins, Lithium, ADHD medication.
  • Insertion of intrauterine device (IUD) - exception: copper
  • Use of emergency contraception in the last 3 months (e.g. Plan B)
  • Severe food allergies (e.g. soy, nuts)
  • Smoking, use of performance enhancing drugs (growth hormones, testosterone)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

Канада · 1 центр
  • Goldring Center for High Performance Sport — Toronto

Идентификаторы

NCT: NCT07258576 · MCOC - REB00048059

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗