- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07561619
Yeast Protein for Muscle Mass
Yeast Protein for Muscle Anabolism: A Randomized Controlled Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a double-blinded randomized clinical trial of a 16-week nutrition intervention with yeast and whey protein in 72 people (36 per group; 18 male and 18 female) between the ages of 18 and 35, recruited from the University of Alberta campus, Edmonton, Canada. Consenting participants will be randomly assigned to one of two groups: whey protein or yeast protein by the study coordinator, who will not collect study outcome measurements or analyze the data.
The goal of the trial is to determine if consumption of 40 g per day of yeast protein produces similar effects to 40 g supplementation with whey protein. It is anticipated that daily yeast protein consumption will show similar gains in muscle mass and improvement in immune function, increased diversity in gut microbiota, and amino acid-derived metabolites compared to whey protein.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jianping Wu, PhD
- Número de teléfono: (780) 492-6885
- Correo electrónico: jwu3@ualberta.ca
Ubicaciones de estudio
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Alberta
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Edmonton, Alberta, Canadá, T6G 2R3
- The University of Alberta North Campus
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Contacto:
- Jianping Wu, PhD
- Número de teléfono: (780) 492-6885
- Correo electrónico: jwu3@ualberta.ca
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Investigador principal:
- Jianping Wu, PhD
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Investigador principal:
- Vera Mazurak, PhD
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Investigador principal:
- Normand Bouleé, PhD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Participants must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and follow-up.
- Prior resistance training experience (defined as performing resistance exercises >1/week for the past 3 months or longer) to enable them to reach a large training stimulus relatively quickly and to avoid the longer phase of neuromuscular adaptations
- ≥18 years and <35 years of age
Exclusion Criteria:
- Diabetes, musculoskeletal disease, cancer, Crohn's disease, or any other acute or chronic condition that interferes (or the medication prescribed for those conditions) with muscle anabolism.
- Diagnosed with or being treated for heart disease, stroke, high blood pressure 130/80 mmHg or higher
- Pain/discomfort/pressure in the chest during activities of daily living or physical activity
- Pregnant or not on adequate contraception.
- A known hypersensitivity/allergy to ingredients in the supplements.
- Inflammatory bowel diseases
- Enrolment in any other clinical protocol or investigational study that may interfere with study procedures
- Taking antibiotics
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Proteína de suero
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Lower and upper body resistance training exercises 3 times a week for 16 weeks
60g of protein supplement (40g of protein).
Oral administration, 30g during exercise and anytime after exercise, or 30g in the morning and evening if no exercise is performed for a period of 16 weeks.
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Experimental: Yeast Protein
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Lower and upper body resistance training exercises 3 times a week for 16 weeks
60g of protein supplement (40g of protein).
Oral administration, 30g during exercise and anytime after exercise, or 30g in the morning and evening if no exercise is performed for a period of 16 weeks.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes in muscle mass
Periodo de tiempo: 16 weeks
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The primary outcome of the study is the change in muscle mass.
It is hypothesized that participants consuming yeast protein will show an increase in appendicular lean mass similar to that observed with whey protein.
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16 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes in muscle function, inflammatory biomarkers, oxidative stress markers, gut microbiota and metabolites
Periodo de tiempo: 16 weeks
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The secondary outcomes of the study include changes in muscle function, which will be assessed through one repetition maximum (1RM) testing for both the bench press and leg press.
Additionally, the investigators will evaluate inflammatory biomarkers, specifically plasma cytokines, as well as oxidative stress markers such as glutathione, total antioxidant capacity, and protein carbonyl levels.
The study will also investigate gut microbiota and metabolites.
The investigators hypothesize that the secondary outcomes will show similar effects in participants taking yeast protein compared to those taking whey protein.
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16 weeks
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Cermak NM, Res PT, de Groot LC, Saris WH, van Loon LJ. Protein supplementation augments the adaptive response of skeletal muscle to resistance-type exercise training: a meta-analysis. Am J Clin Nutr. 2012 Dec;96(6):1454-64. doi: 10.3945/ajcn.112.037556. Epub 2012 Nov 7.
- Patel S. Emerging trends in nutraceutical applications of whey protein and its derivatives. J Food Sci Technol. 2015 Nov;52(11):6847-58. doi: 10.1007/s13197-015-1894-0. Epub 2015 Jun 9.
- West DWD, Abou Sawan S, Mazzulla M, Williamson E, Moore DR. Whey Protein Supplementation Enhances Whole Body Protein Metabolism and Performance Recovery after Resistance Exercise: A Double-Blind Crossover Study. Nutrients. 2017 Jul 11;9(7):735. doi: 10.3390/nu9070735.
- Norton LE, Wilson GJ, Layman DK, Moulton CJ, Garlick PJ. Leucine content of dietary proteins is a determinant of postprandial skeletal muscle protein synthesis in adult rats. Nutr Metab (Lond). 2012 Jul 20;9(1):67. doi: 10.1186/1743-7075-9-67.
- Joy JM, Lowery RP, Wilson JM, Purpura M, De Souza EO, Wilson SM, Kalman DS, Dudeck JE, Jager R. The effects of 8 weeks of whey or rice protein supplementation on body composition and exercise performance. Nutr J. 2013 Jun 20;12:86. doi: 10.1186/1475-2891-12-86.
- Banaszek A, Townsend JR, Bender D, Vantrease WC, Marshall AC, Johnson KD. The Effects of Whey vs. Pea Protein on Physical Adaptations Following 8-Weeks of High-Intensity Functional Training (HIFT): A Pilot Study. Sports (Basel). 2019 Jan 4;7(1):12. doi: 10.3390/sports7010012.
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Pro00156043
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- CIF
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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