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- Ensayo clínico NCT02406040
Effects of Short-term Energy Deficit on Muscle Protein Turnover
14 de marzo de 2016 actualizado por: Stuart M. Phillips, McMaster University
Weight loss through energy restriction results in the loss of both fat and muscle mass.
Muscle mass is important for mobility, strength, glucose control and energy expenditure, and therefore the retention of muscle mass during energy restriction is an important goal.
The retention of muscle mass depends on the balance between muscle protein synthesis (MPS) and muscle protein breakdown (MPB).
It is well known that MPS is reduced during weight loss, however the effect of weight loss on MPB is currently a topic of debate.
The purpose of this study is to assess the effect of short-term (10 day) weight loss (40% energy deficit) on both MPS and MPB in order to gain insight into the mechanisms causing muscle loss during energy restriction.
In addition, the effect of resistance exercise and protein (both known to preserve muscle mass) on MPS and MPB will be examined
Descripción general del estudio
Descripción detallada
An undesirable consequence of energy restriction is the loss of muscle mass.
Muscle mass is determined by the the rates of two processes: muscle protein synthesis and muscle protein breakdown.
It has been consistently shown that a reduced rate of muscle protein synthesis exists during energy restriction.
However, it is currently unclear whether an increase in muscle protein breakdown also contributes to muscle mass loss.
In addition, the effect of high protein diets and resistance exercise on muscle protein turnover during energy restriction, two interventions known to preserve muscle, remains to be investigated.We aim to demonstrate that the decrease in muscle protein synthesis is the main contributor to a negative protein balance during energy restriction.
In addition, we hope to show that a higher-protein diet (2.4g/kg/d versus 1.2g/kg/d) and the addition of resistance exercise can help to maintain the muscle protein synthesis rate and thereby improve negative protein balance.The present study will be designed as a parallel group randomized controlled trial.
Subjects will be given pre-packaged diets (Copper County Foods) to consume which will put them in a relative energy deficit of 40% per day.
Based on random assignment, these subjects will either consume an adequate protein diet (1.2g/kg/d) or a high protein diet (2.4g/kg/d) for 10 consecutive days.
Participants in the adequate protein diet will consume a ratio of 50:35:15 (carbohydrates:fat:protein) while subjects within the high protein diet will consume a ratio of 50:15:35 (carbohydrates:fat:protein).
Subjects will undergo testing at baseline and following a 10 day dietary and unilateral resistance exercise intervention.
Testing will consist of muscle and blood samples.
Muscle protein synthesis and muscle protein breakdown will be measured using stable isotope tracers that are orally ingested (deuterated water) or infused into an antecubital vein (labelled phenylalanine tracers) before and after the 10 day diet.
Tipo de estudio
Intervencionista
Inscripción (Actual)
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.
Ubicaciones de estudio
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Ontario
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Hamilton, Ontario, Canadá, L8S 4K1
- Exercise Metabolism Research Laboratory, McMaster Univeristy
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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
20 años a 30 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Masculino
Descripción
Inclusion Criteria:
- Between the ages of 20 and 30 years inclusive
- Have a BMI between 25 and 33 inclusive
Exclusion Criteria:
- Have a body mass index less than 25 kg/m2 or greater than 33 kg/m2.
- Vegan
- History of allergy, sensitivity, or strong dislike towards dairy protein
- Smoker or user of tobacco products
- High physical activity
- Have health problems such as: renal or gastrointestinal disorders, metabolic disease, heart disease, vascular disease, rheumatoid arthritis, diabetes, poor lung function, uncontrolled blood pressure, dizziness, thyroid problems, or any other health conditions for which volunteers are being treated that might put them at risk for this study.
- Taking anti-diabetic, anti-inflammatory, platelet inhibitor, or anti-coagulant medications
- Use of an investigational drug product within the last 30 days
- Have participated in an infusion protocol in the last year
- Do not understand English or have a condition the PI believes would interfere with the ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put volunteers at undue risk
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 paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: High Protein
2.4g protein/kg/d.
The macronutrient composition will be 50:15:35 (carbohydrates:fat:protein) during Energy Restriction
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All meals will be provided for the duration of the energy restriction intervention and the energy deficit will be calculated based on estimated energy requirements by indirect calorimetry to provide 60% of energy requirements.
In addition, one leg will be assigned to perform resistance exercise for 5 days during the 10 day energy deficit.
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Experimental: Adequate Protein
1.2g protein/kg/d.
The macronutrient composition will be 50:35:15 (carbohydrates:fat:protein) during Energy Restriction
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All meals will be provided for the duration of the energy restriction intervention and the energy deficit will be calculated based on estimated energy requirements by indirect calorimetry to provide 60% of energy requirements.
In addition, one leg will be assigned to perform resistance exercise for 5 days during the 10 day energy deficit.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Muscle protein turnover
Periodo de tiempo: Baseline and 10 days
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Change in muscle protein synthesis and muscle protein breakdown before and after the weight loss diet will be assessed.
The relationship between high protein diets (parallel groups) and exercise (unilateral resistance exercise) on muscle protein turnover will also be examined.
Muscle protein synthesis and muscle protein breakdown will be measured with stable isotope infusions of labelled phenylalanine tracers before and after the 10 day diet.
In addition, long term muscle protein synthesis will be measured with orally ingested deuterated water.
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Baseline and 10 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Molecular markers
Periodo de tiempo: Baseline and 10 days
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Change in the the transcriptional expression of genes involved in the ubiquitin-proteasome pathway (main regulator of muscle protein breakdown) measured in muscle samples obtained at baseline and following the 10 day dietary intervention by quantitative polymerase chain reaction (qPCR).
These same samples will be analyzed by western blot for the expression of active and inactive isoforms of caspase-3, an important component of muscle protein breakdown.
Finally, immunoprecipitation and western blot will be used to examine the ubiquitination of translation initiation factors at baseline and following the 10 day intervention
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Baseline and 10 days
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Areta JL, Burke LM, Camera DM, West DW, Crawshay S, Moore DR, Stellingwerff T, Phillips SM, Hawley JA, Coffey VG. Reduced resting skeletal muscle protein synthesis is rescued by resistance exercise and protein ingestion following short-term energy deficit. Am J Physiol Endocrinol Metab. 2014 Apr 15;306(8):E989-97. doi: 10.1152/ajpendo.00590.2013. Epub 2014 Mar 4.
- Pasiakos SM, Cao JJ, Margolis LM, Sauter ER, Whigham LD, McClung JP, Rood JC, Carbone JW, Combs GF Jr, Young AJ. Effects of high-protein diets on fat-free mass and muscle protein synthesis following weight loss: a randomized controlled trial. FASEB J. 2013 Sep;27(9):3837-47. doi: 10.1096/fj.13-230227. Epub 2013 Jun 5.
- Pasiakos SM, Vislocky LM, Carbone JW, Altieri N, Konopelski K, Freake HC, Anderson JM, Ferrando AA, Wolfe RR, Rodriguez NR. Acute energy deprivation affects skeletal muscle protein synthesis and associated intracellular signaling proteins in physically active adults. J Nutr. 2010 Apr;140(4):745-51. doi: 10.3945/jn.109.118372. Epub 2010 Feb 17.
- Hector AJ, Marcotte GR, Churchward-Venne TA, Murphy CH, Breen L, von Allmen M, Baker SK, Phillips SM. Whey protein supplementation preserves postprandial myofibrillar protein synthesis during short-term energy restriction in overweight and obese adults. J Nutr. 2015 Feb;145(2):246-52. doi: 10.3945/jn.114.200832. Epub 2014 Dec 17. Erratum In: J Nutr. 2015 Jun;145(6):1373.
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
1 de junio de 2015
Finalización primaria (Actual)
1 de enero de 2016
Finalización del estudio (Actual)
1 de enero de 2016
Fechas de registro del estudio
Enviado por primera vez
28 de marzo de 2015
Primero enviado que cumplió con los criterios de control de calidad
28 de marzo de 2015
Publicado por primera vez (Estimar)
1 de abril de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
16 de marzo de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
14 de marzo de 2016
Última verificación
1 de marzo de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- Not assigned (Charles A. Dana Foundation Brain and Immuno-Imaging Grant)
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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