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Идёт набор NCT07579455

Acute Pharmacokinetics of Create Wellness Gummies in Healthy Adults

Без фазы С лечением Creatine Absorption in Healthy Adults

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: Create Wellness Creatine Gummies, Creatine Monohydrate Powder.
Кому может быть актуально
Состояния в реестре: Creatine Absorption in Healthy Adults. Базовые параметры: 18 лет — 45 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

The purpose of this study is to compare blood creatine levels following acute oral supplementation of Create Wellness creatine gummies to creatine monohydrate powder.

Подробное описание

To examine and compare acute effects of Create Wellness creatine gummies and creatine monohydrate powder on blood creatine levels.

Prior to the baseline visit, each participant will be sent an electronic version of the informed consent to review participation details. Those interested will complete a phone screening for inclusion/exclusion criteria. If the participant qualifies for the study and is interested in participating, verbal consent will be obtained. An electronic link for written consent and a self-reported medical health history questionnaire will be sent after verbal consent. Each participant will provide electronic written informed consent and complete the health/medical history questionnaire. Following written electronic consent, health history will be reviewed by the research team to confirm eligibility.

Visits 1 \& 2: Participants will be asked to arrive to the laboratory after an 8-hour overnight fast from caloric foods and beverages and having abstained from vigorous exercise, caffeine, alcohol, and tobacco for the previous 24-hours. Anthropometrics (height and weight) and body composition (via multi-frequency bioelectrical impedance analysis) will be obtained upon arrival and a urine sample will be collected to determine acute hydration and pregnancy status for female participants. Blood samples will then be obtained from the antecubital region at baseline and 30-min, 1-hour, 2-hours, 3-hours, 4-hours, and 5-hours following oral ingestion of the assigned supplement. Participants will be randomized to supplement order of Create Wellness creatine gummies (3 gummies, 4.5 grams of creatine monohydrate) or creatine monohydrate powder (4.5 grams creatine monohydrate in 240 mL water). Gastrointestinal surveys will be also be collected. All research visits will take place at the ATHENA Laboratory in the Health and Exercise Science Department at the University of Oklahoma, Norman Campus. All data will be collected by the Principal Investigator and ATHENA Laboratory Research Assistants.

Вмешательства

  • Пищевая добавка Create Wellness Creatine Gummies
    Create Wellness creatine gummies provide 4.5 grams of creatine monohydrate in a 3 gummy serving size.
  • Пищевая добавка Creatine Monohydrate Powder
    4.5 grams of creatine monohydrate powder (Creapure®) dissolved in 240 mL of water.

Первичные конечные точки

  • Peak plasma concentration (Cmax) [Срок оценки: 0 to 5-hours following supplementation.]
  • Time to peak plasma concentration (Tmax) [Срок оценки: 0 to 5-hours following supplementation.]
  • Area under the curve (AUC) [Срок оценки: 0 to 5-hours following supplementation.]

Критерии участия

Критерии включения

  • Adults between the ages of 18-45 yrs
  • Body mass index of <35 kg/m2
  • Recreationally active \[(≥30 minutes of moderate-intensity physical activity per week as defined by the International Physical Activity Questionnaire (IPAQ)\]
  • Healthy and free from major diseases as determined from screening call and health history questionnaire.
  • Agrees to complete pre-assessment guidelines (8-hour fast from caloric foods and beverages, 24-hour abstention from vigorous physical activity, caffeine, alcohol, and tobacco).

Критерии исключения

  • Chronic kidney disease, liver disease, chronic obstructive pulmonary disease, or cancer.
  • Currently using medications that may directly impact the primary outcomes including: diuretics and corticosteroids).
  • Currently using creatine monohydrate
  • Severely impaired hearing or speech or inability to speak English.

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
Простое слепое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • ATHENA Laboratory — Norman

Идентификаторы

NCT: NCT07579455 · 19428

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗