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Набор по приглашению NCT07402902

Caffeine Strategies and Fat Oxidation

Без фазы С лечением Fat Metabolism Caffeine Cycling Exercise

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: Caffeine (Guinama Anhydrous Powder), Caffeine (Nescafé Classic Coffee), Caffeine (Kafewake Gum), Caffeine Mouth Rinse Solution.
Кому может быть актуально
Состояния в реестре: Fat Metabolism, Caffeine, Cycling, Exercise. Базовые параметры: 18 лет — 50 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
Испания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effects of Different Caffeine Ingestion Forms on Fat Oxidation During Cycle Ergometer Exercise

Обзор

The goal of this clinical trial is to learn if different forms of caffeine ingestion can influence fat oxidation during submaximal cycling exercise. The study will recruit healthy adults, both men and women, aged 18 to 50, who regularly perform aerobic exercise. The main questions it aims to answer are: * Does caffeine increase fat oxidation during one hour of cycling at the Fatmax intensity? * Do different forms of caffeine ingestion (capsule, coffee, chewing gum, or mouth rinse) differ in their effect on fat oxidation? * Do these caffeine forms alter total energy expenditure, cardiorespiratory response, or perceived exertion during exercise? * Are there differences in the occurrence or severity of side effects between caffeine administration methods? Researchers will compare each caffeine form to its corresponding placebo to determine their effects on fat oxidation and other physiological outcomes. Participants will: * Attend a pre-experimental session to determine their Fatmax intensity and VO₂max using an incremental cycling test * Perform eight experimental sessions, each consisting of one hour of cycling at Fatmax intensity * Receive caffeine or placebo via capsules, coffee, chewing gum, or mouth rinse according to a randomized, double-blind, crossover design * Be monitored for fat and carbohydrate oxidation, total energy expenditure, heart rate, and perceived exertion during exercise * Report any side effects immediately after the session and 24 hours later using a structured questionnaire All sessions will be conducted under controlled laboratory conditions with standardized protocols to ensure safety and reliable measurements.

Вмешательства

  • Препарат Caffeine (Guinama Anhydrous Powder)
    3 mg/kg of anhydrous caffeine powder (Guinama, Spain) administered in an opaque capsule 60 min before exercise.
  • Пищевая добавка Caffeine (Nescafé Classic Coffee)
    3 mg/kg of caffeine via Nescafé Classic (Nestlé, Switzerland) dissolved in 250 mL of water 60 min before exercise.
  • Пищевая добавка Caffeine (Kafewake Gum)
    3 mg/kg of caffeine via Kafewake gum (Arafarma group, Spain), chewed for 10 min before exercise.
  • Другое Caffeine Mouth Rinse Solution
    3 mg/kg of caffeine (Nescafé Classic) dissolved in 25 mL of water for a 20-second rinse before exercise.
  • Другое Placebo (Cellulose Capsule)
    Opaque capsule containing cellulose powder, matching caffeine capsules, taken 60 min before exercise.
  • Другое Placebo (Decaffeinated Coffee)
    Decaffeinated Nescafé (Nestlé, Switzerland) in 250 mL of water, matching caffeinated coffee, taken 60 min before.
  • Другое Placebo (Non-caffeine Gum)
    Kafewake Non-caffeinated gum (Arafarma group, Spain) with identical taste and texture, chewed for 10 min before.
  • Другое Placebo Mouth Rinse Solution
    Decaffeinated Nescafé in 25 mL of water for a 20-second rinse immediately before exercise.

Первичные конечные точки

  • Rate of fat oxidation during submaximal cycling exercise at Fatmax intensity [Срок оценки: 1 hour per experimental session]
Вторичные конечные точки (8)
  • Rate of carbohydrate oxidation during submaximal cycling exercise at Fatmax intensity [Срок оценки: 1 hour per experimental session]
  • Total energy expenditure during exercise [Срок оценки: 1 hour per experimental session]
  • Mean Exercise Heart Rate [Срок оценки: 1 hour per experimental session]
  • Oxygen consumption [Срок оценки: 1 hour per experimental session]
  • Carbon Dioxide Production [Срок оценки: 1 hour per experimental session]
  • Blood lactate concentration [Срок оценки: Every 20 minutes during each 1-hour session]
  • Rating of Perceived Exertion (RPE) during exercise [Срок оценки: Every 10 minutes during each 1-hour session]
  • Occurrence of caffeine-related side effects [Срок оценки: Immediately after each session and 24 hours post-exercise]

Критерии участия

Критерии включения

  • Healthy men and women aged 18-50 years
  • Regular aerobic exercise at least 1 hour per day, 2 days per week
  • Provide written informed consent

Критерии исключения

  • Smoking
  • Use of medication or ergogenic supplements during the study period
  • Caffeine intolerance or allergy
  • Cardiopulmonary or musculoskeletal disorders
  • Use of oral contraceptives in female participants

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
Двойное слепое
Основная цель
Фундаментальное исследование

Центры проведения

Испания · 1 центр
  • Estadio Raúl González Blanco, Camino del Molino 5 — Fuenlabrada

Публикации

  • Guest NS, VanDusseldorp TA, Nelson MT, Grgic J, Schoenfeld BJ, Jenkins NDM, Arent SM, Antonio J, Stout JR, Trexler ET, Smith-Ryan AE, Goldstein ER, Kalman DS, Campbell BI. International society of sports nutrition position stand: caffeine and exercise performance. J Int Soc Sports Nutr. 2021 Jan 2;18(1):1. doi: 10.1186/s12970-020-00383-4. PMID 33388079
  • Ruiz-Moreno C, Gutierrez-Hellin J, Amaro-Gahete FJ, Gonzalez-Garcia J, Giraldez-Costas V, Perez-Garcia V, Del Coso J. Caffeine increases whole-body fat oxidation during 1 h of cycling at Fatmax. Eur J Nutr. 2021 Jun;60(4):2077-2085. doi: 10.1007/s00394-020-02393-z. Epub 2020 Oct 6. PMID 33025051

Идентификаторы

NCT: NCT07402902 · URJC-CAF-FOX-2026

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗