Effects of Whey Protein and Resistance Training on Muscle Mass in Patients With Intestinal Failure
Effect of Whey Protein Supplementation Combined With Resistance Training on Muscle Mass in Patients With Intestinal Failure: A Randomized Controlled Trial
This single-center, prospective, four-arm randomized controlled trial will enroll 72 adults with chronic intestinal failure and low muscle mass. All participants will receive standardized basic nutritional support and will be randomly assigned to one of four groups: usual care, whey protein supplementation, resistance training, or whey protein supplementation combined with resistance training.
Participants assigned to whey protein supplementation will receive 20 g of whey protein daily for 6 weeks. Participants assigned to resistance training will complete moderate-intensity resistance exercises for approximately 30 minutes, 3 to 5 times per week, for 6 weeks. Participants in the combined group will receive both interventions.
Body composition, appendicular skeletal muscle mass index, phase angle, handgrip strength, 6-meter walking speed, laboratory indicators, and quality of life will be assessed at baseline, week 6, and week 8. The study aims to evaluate the effectiveness and safety of whey protein supplementation and resistance training, alone or in combination, for improving muscle mass and physical function in patients with chronic intestinal failure.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients with chronic intestinal failure and low muscle mass.
- Willing to participate in the study and provide written informed consent.
- Able to complete the assigned 6-week intervention and the assessments at baseline, week 6, and week 8.
Exclusion Criteria:
- Known allergy to whey protein.
- Severe renal dysfunction.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Control Group
Participants will receive standardized basic nutritional support and usual clinical care without additional whey protein supplementation or protocol-specified resistance training.
|
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Experimental: Resistance Training Group
Participants will receive standardized basic nutritional support and moderate-intensity resistance training for approximately 30 minutes per session, 3 to 5 times per week, for 6 weeks.
|
Participants will perform moderate-intensity resistance training for approximately 30 minutes per session, 3 to 5 times per week, for 6 weeks, in addition to standardized basic nutritional support.
|
|
Experimental: Combined Intervention Group
Participants will receive standardized basic nutritional support, 20 g of whey protein orally once daily, and moderate-intensity resistance training for approximately 30 minutes per session, 3 to 5 times per week, for 6 weeks.
|
Participants will perform moderate-intensity resistance training for approximately 30 minutes per session, 3 to 5 times per week, for 6 weeks, in addition to standardized basic nutritional support.
Participants will receive standardized basic nutritional support and 20 g of whey protein orally once daily for 6 weeks.
|
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Experimental: Whey Protein Supplementation Group
|
Participants will receive standardized basic nutritional support and 20 g of whey protein orally once daily for 6 weeks.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Change in Appendicular Skeletal Muscle Mass Index
Periodo de tiempo: Baseline, Week 6, and Week 8
|
Baseline, Week 6, and Week 8
|
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026DZKY-134-01
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.
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