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Набор скоро начнётся NCT06612658

Acute Effect of Capsimax on Resistance Exercise Performance, Muscle Oxygenation, Nitric Oxide Release, Resting Energy Expenditure and Reaction Time

Без фазы С лечением None Volunteer

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: A novel, proprietary encapsulated form of Capsicum extract in beadlet form standardized to 2% capsaicinoids.
Кому может быть актуально
Состояния в реестре: None Volunteer. Базовые параметры: 18 лет — 35 лет · Мужчины.
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
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Официальное название

A Prospective, Randomized Double-Blind, Placebo-Controlled, Cross-Over Study to Evaluate Acute Effect of Capsimax on Resistance Exercise Performance, Muscle Oxygenation, Nitric Oxide Release, Resting Energy Expenditure and Reaction Time

Обзор

Capsimax is a novel, proprietary encapsulated form of capsaicin, a natural and bioactive phytochemical found in chili pepper and other spicy food. The purpose of this study is to investigate the effect of Capsimax on resistance exercise performance, reaction time, and resting energy expenditure around exercise. This investigation will also measure muscle oxygenation and intramuscular nitric oxide in real time during resistance exercise using a non-invasive wearable technology. Primary Objective • To examine the effects of Capsimax on physical performance metrics including peak power and rate of force development during an isometric strength test and performance during the barbell back squat exercise protocol (e.g., repetitions performed, total volume, peak power, average power). Secondary Objectives * To examine the effects of Capsimax on resting energy expenditure around exercise. * To examine the effects of Capsimax on nitric oxide bioavailability and skeletal muscle oxygenation during exercise. Exploratory Objective • To examine the effects of Capsimax on reaction time around exercise

Подробное описание

Capsimax is a novel, proprietary encapsulated form of capsaicin, a natural and bioactive phytochemical found in chili pepper and other spicy food. The purpose of this study is to investigate the effect of Capsimax on resistance exercise performance, reaction time, and resting energy expenditure around exercise. This investigation will also measure muscle oxygenation and intramuscular nitric oxide in real time during resistance exercise using a non-invasive wearable technology.

Primary Objective • To examine the effects of Capsimax on physical performance metrics including peak power and rate of force development during an isometric strength test and performance during the barbell back squat exercise protocol (e.g., repetitions performed, total volume, peak power, average power).

Secondary Objectives

* To examine the effects of Capsimax on resting energy expenditure around exercise. * To examine the effects of Capsimax on nitric oxide bioavailability and skeletal muscle oxygenation during exercise.

Exploratory Objective

• To examine the effects of Capsimax on reaction time around exercise

Вмешательства

  • Пищевая добавка A novel, proprietary encapsulated form of Capsicum extract in beadlet form standardized to 2% capsaicinoids
    This study will investigate the effect of the supplement on exercise performance.

Первичные конечные точки

  • Resistance exercise performance [Срок оценки: 1 day]
  • Isometric strength test [Срок оценки: 1 day]
Вторичные конечные точки (3)
  • Energy expenditure [Срок оценки: 1 day]
  • Nitric oxide release and skeletal muscle oxygenation [Срок оценки: 1 day]
  • Subjective feelings of pain and rating of perceived exertion [Срок оценки: 1 day]

Критерии участия

Критерии включения

  • Male subjects aged between 18-35 years (both limits inclusive).
  • Subjects must have a BMI of 18.5 to 29.9 kg/m2 (both limits inclusive)
  • Subjects must have greater than one year of resistance training experience at a frequency of 2 days per week.
  • Subjects must be proficient in the barbell back squat exercise.
  • Subjects must be free of any physical limitations or chronic illness that may affect performance.
  • Subjects must be free of any medications.
  • Subjects who agree to refrain from consuming alcohol 24 hours prior to the visit days.
  • Subjects who agreed to refrain from consuming caffeine and caffeine-containing products 12 hour prior to visit days
  • Subject willing to provide written consent.

Критерии исключения

  • Subjects who have hypersensitivity or history of allergy to the study product.
  • Subjects with inability to swallow soft gel capsules.
  • Subjects with any other medical condition that might adversely impact the safety of the study participants or confound the study results.
  • Subjects who require medications.
  • Subjects who regularly use a dietary supplement containing Capsimax or other ingredients that would impact study endpoints.
  • Subjects who had been treated with any investigational drug or investigational device within a period of 3 months prior to study entry

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Тройное слепое
Основная цель
Другое

Центры проведения

США · 1 центр
  • Hofstra University — Hempstead

Идентификаторы

NCT: NCT06612658 · 20240805-AHK-SHS-GON-1 · HO-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗