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FueL Use During eXercise in Males and Females (FLUX)

14 de septiembre de 2026 actualizado por: Jenna Gillen, University of Toronto

Influence of Pre-exercise Nutrition on Exercise Fuel Use in Males and Females

This study will investigate whether pre-exercise nutrition influences sex differences in fuel utilization during endurance exercise. Twenty-four recreationally active adults (12 females and 12 males) will complete three experimental exercise trials in a randomized, counterbalanced crossover design. Before each trial, participants will consume either a carbohydrate beverage, a protein-based beverage, or a flavour-matched non-caloric beverage representing the fasted condition. Thirty minutes later, participants will complete 90 minutes of moderate-intensity cycling followed by a cycling time-to-task-failure test. Whole-body carbohydrate and fat oxidation, exogenous substrate oxidation, blood metabolites, and exercise performance will be assessed.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

Sex differences in substrate utilization during fasted endurance exercise are well established, with females generally demonstrating greater reliance on fat oxidation and lower carbohydrate utilization than males. However, exercise is frequently performed following nutrient ingestion, and it remains unclear whether sex differences in substrate utilization persist when carbohydrate or protein is consumed before exercise.

This randomized, counterbalanced crossover study will compare three pre-exercise nutritional conditions: carbohydrate (CHO), protein (PRO), and fasted/placebo (FAST). Participants will complete each condition separated by a minimum three-day washout. Following an overnight fast, participants will consume the assigned beverage and rest for 30 minutes before completing 90 minutes of cycling at 65% of VO2peak. This will be followed by a two-minute rest and a cycling time-to-task-failure test at 85% of maximal work rate.

The primary objective is to determine whether pre-exercise nutrition modifies sex differences in whole-body carbohydrate and fat oxidation and exogenous substrate oxidation during exercise. A secondary objective is to determine the effects of pre-exercise nutrition and sex on subsequent exercise performance.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

24

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

    • Ontario
      • Toronto, Ontario, Canadá, M5S 2C9

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 35 años (Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Participating in ≥150 minutes of moderate-to-vigorous physical activity per week
  • VO₂peak classified as "good" or above based on American College of Sports Medicine normative values: >35.0 mL/kg/min for females and >39.0 mL/kg/min for males
  • Body mass index (BMI) between 18 and 27 kg/m²
  • Participating in 3-5 structured exercise sessions per week
  • Weight stable, defined as within ±2 kg for at least 6 months
  • Non-smoker
  • Females must be eumenorrheic

Exclusion Criteria:

  • Polycystic ovarian syndrome (PCOS) or endometriosis Current use of oral contraceptives or oral contraceptive use within the previous 3 months Diagnosed cardiovascular or metabolic disease Hypergonadism or hypogonadism Use of medications for management of blood glucose or lipid metabolism Pregnant or <12 months postpartum Lactating or breastfeeding within 3 months of study commencement Menopausal Recreational tobacco smoking Inability to complete the study exercise protocols or comply with pre-trial dietary or physical activity controls Use of medications that may affect substrate metabolism, including corticosteroids or non-steroidal anti-inflammatory drugs (NSAIDs) Currently following a low-carbohydrate diet, such as a ketogenic or Atkins diet

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Ciencia básica
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Carbohydrate (CHO)

Participants will consume a carbohydrate beverage following an overnight fast. Thirty minutes after beverage consumption, participants will complete 90 minutes of cycling at 65% of VO2peak, followed by a 2-minute rest and a cycling time-to-task-failure test at 85% of maximal work rate.

A carbohydrate beverage providing 1 g glucose/kg body mass, enriched with 1 mg/kg body mass [U-13C6]-D-glucose for assessment of exogenous carbohydrate oxidation, with calorie-free flavouring. The beverage will be consumed within 5 minutes, 30 minutes before exercise.

Experimental: Protein (PRO)

Participants will consume a protein-based beverage following an overnight fast. Thirty minutes after beverage consumption, participants will complete 90 minutes of cycling at 65% of VO2peak, followed by a 2-minute rest and a cycling time-to-task-failure test at 85% of maximal work rate.

A protein-based beverage providing 0.45 g protein/kg body mass and supplemented with 0.24 g fat/kg body mass to match the energy content of the carbohydrate condition. The beverage is enriched with L-[1-13C]leucine and flavour-matched to the carbohydrate beverage. It will be consumed within 5 minutes, 30 minutes before exercise.

Comparador de placebos: Fasted (FAST)

Participants will remain fasted and consume a non-caloric, flavour-matched beverage. Thirty minutes after beverage consumption, participants will complete 90 minutes of cycling at 65% of VO2peak, followed by a 2-minute rest and a cycling time-to-task-failure test at 85% of maximal work rate.

A non-caloric beverage consisting of water and sugar-free flavouring, flavour-matched to the carbohydrate beverage. The beverage will be consumed within 5 minutes following an overnight fast, 30 minutes before exercise.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Whole-body carbohydrate oxidation
Periodo de tiempo: During the 90-minute exercise bout

Whole-body carbohydrate oxidation will be calculated from oxygen consumption (VO2) and carbon dioxide production (VCO2) measured by indirect calorimetry during 90 minutes of moderate-intensity cycling. Carbohydrate oxidation will be compared between the carbohydrate, protein, and fasted conditions and between females and males.

During the 90-minute exercise bout
Whole-body fat oxidation
Periodo de tiempo: During the 90-min exercise bout

Whole-body fat oxidation will be calculated from VO2 and VCO2 measured by indirect calorimetry during 90 minutes of moderate-intensity cycling. Fat oxidation will be compared between the carbohydrate, protein, and fasted conditions and between females and males.

During the 90-min exercise bout
Exogenous glucose oxidation
Periodo de tiempo: During the 90-min exercise bout

Exogenous glucose oxidation will be determined during the carbohydrate condition using breath 13CO2 enrichment following ingestion of [U-13C6]-D-glucose. Breath samples will be analyzed by isotope ratio mass spectrometry, and exogenous glucose oxidation will be calculated using 13CO2 enrichment and carbon dioxide production.

During the 90-min exercise bout
Exogenous leucine oxidation
Periodo de tiempo: During the 90-min exercise bout

Exogenous leucine oxidation will be determined during the protein condition using breath ¹³CO₂ enrichment following ingestion of L-[1-¹³C]leucine. Breath samples will be analyzed by isotope ratio mass spectrometry, and exogenous leucine oxidation will be calculated using breath ¹³CO₂ enrichment and carbon dioxide production.

During the 90-min exercise bout

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time to task failure
Periodo de tiempo: Immediately following the 90-min exercise bout

Exercise performance will be assessed as time to volitional exhaustion during a cycling time-to-task-failure test performed at 85% of maximal work rate following the 90-minute moderate-intensity cycling bout.

Immediately following the 90-min exercise bout

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Jenna Gillen, PhD, University of Toronto

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

30 de septiembre de 2026

Finalización primaria (Estimado)

30 de junio de 2027

Finalización del estudio (Estimado)

30 de junio de 2027

Fechas de registro del estudio

Enviado por primera vez

14 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

14 de septiembre de 2026

Publicado por primera vez (Actual)

18 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

14 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • HSREB50670

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .