Pre-Exercise Whey and Pea Protein in Adolescents With Type 1 Diabetes
Effects of Pre-Exercise Whey and Pea Protein Intake on Glycemic Responses and Postprandial Appetite During and After Moderate-Intensity Aerobic Exercise in Jordanian Adolescents With Type 1 Diabetes: A Randomized Crossover Trial.
The goal of this clinical trial is to learn whether drinking whey protein or pea protein before exercise affects blood sugar levels and appetite in adolescents with type 1 diabetes. The study will also compare two different amounts of each type of protein.
The main questions this study aims to answer are:
- Does drinking whey or pea protein before exercise affect blood sugar levels during and after moderate-intensity exercise?
- Does the amount of protein consumed before exercise affect blood sugar levels?
- Does whey or pea protein affect feelings of hunger, fullness, and satiety after exercise?
Researchers will compare four conditions: a low and moderate amount of whey protein and a low and moderate amount of pea protein. Each participant will complete all four conditions on separate study visits, allowing researchers to compare the effects within the same person.
Participants will:
- Drink a protein beverage 45 min before exercise.
- Complete 45 min moderate-intensity aerobic exercise under supervision.
- Wear a continuous glucose monitor to measure blood sugar levels during and after exercise.
- Report their feelings of hunger, fullness, and satiety at several times during the study.
- Follow the same general food, physical activity, and diabetes management instructions before each study visit.
The study may help researchers understand whether the type and amount of protein consumed before exercise can help manage blood sugar levels and appetite around exercise in adolescents with type 1 diabetes.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Sondos Alobaidi
- Número de teléfono: 00962796329336
- Correo electrónico: sondosalobaidi@gmail.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Male and female adolescents with T1D
- Age: 12-18 years
- T1D duration ≥ 1 year and HbA1c <10%
- BMI-for Age- z-score between -2 and +2
- Able to complete 45 min moderate-intensity aerobic exercise
- Using CGM or willing / able to wear study CGM
- Using multiple daily injections
Exclusion Criteria:
- Medical comorbidities (celiac disease and thyroid disease),
- Diabetes complications or gastroparesis,
- milk protein allergy or eating disorders,
- severe hypo/ diabetic ketoacidosis in the past 3 months
- Age: <12 or > 18 years
- T1D duration < 1 year or HbA1c ≥10%
- BMI -for Age- z-score < -2 or > +2
- Unable to exercise safely (physical limitations, intellectual disability, autism, mental health conditions)
- Not using/willing/able to use CGM
- Using once daily/mixed insulin regimens
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: low whey protein
Participants will consume a whey protein beverage providing 0.25 g of protein per kg of body weight, 45 minutes before moderate-intensity aerobic exercise. They will then complete the standardized exercise session under supervision. Glucose levels and appetite will be monitored during and after exercise. |
Participants will consume a whey protein beverage providing 0.25 g of protein per kg of body weight, 45 minutes before moderate-intensity aerobic exercise. They will then complete the standardized exercise session under supervision. Glucose levels and appetite will be monitored during and after exercise. |
|
Experimental: moderate whey protein
Participants will consume a whey protein beverage providing the moderate prespecified dose of protein per kg of body weight, 45 minutes before moderate-intensity aerobic exercise. They will then complete the standardized exercise session under supervision. Glucose levels and appetite will be monitored during and after exercise. |
Participants will consume a whey protein beverage providing the moderate prespecified dose of protein per kg of body weight, 45 minutes before moderate-intensity aerobic exercise. They will then complete the standardized exercise session under supervision. Glucose levels and appetite will be monitored during and after exercise. |
|
Experimental: low pea protein
|
Participants will consume a pea protein beverage providing 0.25 g of protein per kg of body weight, 45 minutes before moderate-intensity aerobic exercise. They will then complete the standardized exercise session under supervision. Glucose levels and appetite will be monitored during and after exercise. |
|
Experimental: moderate pea protein
|
Participants will consume a pea protein beverage providing the moderate prespecified dose of protein per kg of body weight, 45 minutes before moderate-intensity aerobic exercise. They will then complete the standardized exercise session under supervision. Glucose levels and appetite will be monitored during and after exercise. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Continuous blood glucose levels using CGM "FreeStyle Libre 2 sensor"
Periodo de tiempo: 3 hours
|
3 hours
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
postprandial appetite using VAS
Periodo de tiempo: 3 hours
|
3 hours
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- UJ-T1D-PRO-2026
- UJ IRB Approval Number (Otro identificador: University of Jordan)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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