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The Role of Carbohydrate Blends and Electrolytes on Physical and Mental Performance During Cycling in the Heat (CARB-HEAT)

17 de junio de 2026 actualizado por: Stavros Kavouras, Arizona State University
The aim of the present study is to evaluate the effectiveness of a milk permeate-based sports drink on hydration, carbohydrate oxidation, exercise performance, vigilance, and reaction time in the heat. We anticipate that the milk permeate, with 44 g per liter and high sodium and potassium, will lead to better hydration, energy delivery, and physical and cognitive performance.

Descripción general del estudio

Descripción detallada

EXPERIMENTAL PROTOCOL Each subject will complete five trials (one familiarization and four experimental), consisting of computer-based vigilance and reaction time tests (VIG/RT) administered before and after approximately 2 hours of cycling in a warm environment (90°F, 25-35% relative humidity). Each trial will be identical, with the only difference being the type of drink consumed during each trial. The beverages are commercially available products and are not considered investigational products under FDA regulations.

The first trial will be a familiarization trial, during which participants will complete the VIG/RT tests and cycling protocol exactly as performed in the experimental trials, but no biological samples will be collected. The remaining trials will be completed in randomized order, and the drink consumed will be:

A) Placebo (flavored water) B) GoodSport® (milk-permeate, lactose-free sports drink) C) Gatorade® (traditional sports drink) D) Low-Carb GoodSport® During the experiments, core body temperature, heart rate, skin temperature, urine samples, and expiratory gases will be collected. Blood samples will be collected using an intravenous catheter placed in an antecubital vein (see protocol figure on the next page). During the familiarization trial, no samples will be collected.

INFORMED CONSENT AND BASELINE ASSESSMENT During the initial visit, subjects will read the consent form, discuss any concerns, and have questions addressed. After signing the consent form, participants will have 20 minutes to complete the medical health history, PAR-Q questionnaire, and Ingestible Core Body Temperature Sensor Contraindication Form in person on paper.

If the volunteer is deemed eligible, height, weight, and body composition will be assessed on site using a bioelectrical impedance analyzer, and the procedure will take approximately five minutes.

Participants will then complete a standard graded exercise test (GXT) performed on a cycle ergometer. Performance data (e.g., power output) obtained from this test will be used to determine the resistance applied to the cycle ergometer during the experimental trials (description provided below). During this test, the investigators will also assess maximal oxygen uptake (VO₂max) via indirect calorimetry to evaluate aerobic capacity.

Once testing is completed, the experimental trials will be scheduled. Participants will receive a food diary form to record all food and fluid intake on the day before each trial, and dietary restrictions or allergies will be documented. Participants will be asked to replicate this intake for subsequent visits. Frozen meals will be provided for consumption as dinner before the first experimental trial. Additional meals will be provided after each experimental visit.

EXPERIMENTAL PROCESSES Subjects will ingest an individually calibrated telemetric temperature pill (e-Celsius®, France) on the evening preceding each trial to avoid interaction with fluid ingestion during testing. Subjects will report to the laboratory after at least 10 hours of fasting from food and beverages other than water, and a urine sample will be collected to verify adequate hydration status.

The urine sample will be analyzed for urine specific gravity (USG). If USG is below 1.020, indicating adequate hydration, the protocol will proceed. If USG is greater than 1.029, the trial will be canceled and rescheduled. If USG is between 1.020 and 1.029, the volunteer will consume 16 oz of water, and another urine sample will be collected within 30 minutes. The trial will be canceled and rescheduled unless USG is below 1.020 at the subsequent sample or unless the volunteer is unable to provide an additional sample.

At the start of each experimental trial, subjects will consume a light breakfast, after which body composition will be assessed using a bioelectrical impedance scale. Subjects will then complete the vigilance and reaction time tests. After completion of the tests, an intravenous catheter will be placed in an antecubital vein, and a baseline blood sample will be collected. Subjects will then void the bladder, and body weight will be measured. Once these procedures are completed, subjects will be positioned on the cycle ergometer.

Cycling Endurance Exercise Performance Each trial includes 120 minutes of cycling at 70% of VO₂max, followed by a 5-km time trial. A relative beverage volume of 15 mL/kg/h will be provided. The total beverage volume will be divided into aliquots and administered every 10 minutes during the 120-minute exercise period.

At the end of the 120-minute exercise bout, subjects will consume an additional beverage bolus before the 5-km time trial (see Figure 1 for drink timing), and another bolus will be consumed immediately before the post-exercise vigilance and reaction time (VIG/RT) tests. After completion of the tests, body composition will again be assessed using a bioelectrical impedance scale.

At regular intervals throughout the exercise protocol, body weight, blood samples, respiratory gases, and perceptual measures will be collected. See the study schematic provided below for specific measurement time points.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

14

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

  • Nombre: Sajjad Rezaei, MS
  • Número de teléfono: 515-441-4904
  • Correo electrónico: srezaei8@asu.edu

Ubicaciones de estudio

    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85004
        • 850 Phoenix Bioscience Core
        • Investigador principal:
          • Stavros Kavouras, PhD
        • Contacto:

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

  • Adulto

Acepta Voluntarios Saludables

Sí

Descripción

Inclusion Criteria:

  • Healthy and injury free (muscle, skeletal) for greater than 2 months
  • Active cyclists who train at least 3 times per week
  • Body mass index (BMI) range of 18.5-30 kg/m2
  • VO₂max ≥ 51 mL/kg/min for male participants
  • VO₂max ≥ 45 mL/kg/min for female participants

Exclusion Criteria:

  • Taking medicine influences the cardiovascular system
  • non-steroidal anti-inflammatory drugs during the last week
  • Cancer Diagnosis during the last 5 years
  • Current Pregnancy
  • History of renal disease, hypertension, obstructive gastrointestinal tract disease, disorders or impairment of the gag reflex, previous gastrointestinal surgery
  • History of heat stroke
  • Use of testosterone therapy
  • Adults who are unable to consent (impaired decision-making capacity)
  • Adults having Felinization of the esophagus
  • Adults who will undergo Nuclear Magnetic Resonance (NMR) or MRI scanning within 3 days of swallowing a temperature sensitive pills

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: Otro
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: Placebo
no caloric, no sodium containing flavor water
Flavor water
Experimental: Carbohydrate Milk Permeate sports drink
GoodSport sports drink
4.4% carbohydrate sports drink
Experimental: Traditional Sports drink with 6% carbs
Gatorade sports drink
Gatorade with 6% carbohydrate content
Experimental: Low Carbohydrate Milk Permeate sports drink
LowCarb GoodSport sports drink
2.2% Carbohydrate Milk Permeate sports drink

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time to completion of 5 kilometer cycling time trial
Periodo de tiempo: Five minutes after completion of the two-hour cycling protocol
cycling performance expressed as time to completion.
Five minutes after completion of the two-hour cycling protocol
Psycho-motor Vigilance test
Periodo de tiempo: Five minutes after completion of the 5-kilometer cycling test
Psycho-motor Vigilance test measured by reaction time in milliseconds
Five minutes after completion of the 5-kilometer cycling test

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Plasma Osmolality
Periodo de tiempo: Plasma osmolality at 0, 30, 60, 90, and 120 minutes of the 2-hour steady cycling, at the end of the 5-kilometer cycling time trial, and within 2 minutes after the cognitive test.
Plasma osmolality
Plasma osmolality at 0, 30, 60, 90, and 120 minutes of the 2-hour steady cycling, at the end of the 5-kilometer cycling time trial, and within 2 minutes after the cognitive test.
Carbohydrate oxidation rate during exercise
Periodo de tiempo: At minutes 15, 60, and 120 of the 2-h steady-state cycling exercise
Carbohydrate oxidation rate during 2-h steady-state cycling exercise
At minutes 15, 60, and 120 of the 2-h steady-state cycling exercise

Colaboradores e Investigadores

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

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)

22 de junio de 2026

Finalización primaria (Estimado)

30 de marzo de 2027

Finalización del estudio (Estimado)

31 de diciembre de 2027

Fechas de registro del estudio

Enviado por primera vez

10 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

17 de junio de 2026

Publicado por primera vez (Actual)

22 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de junio de 2026

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

17 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

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. .

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