- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00926250
Effects of PS-IPC Supplementation on Muscle Mass and Functional Outcomes in Older Adults (PS-IPC)
Effects of Pro-Stat Immuno-Protein Complex (PS-IPC) Supplementation on Muscle Mass and Function, Inflammatory Markers, and Immune Function in Older Adults
Sarcopenia, the age-associated loss of skeletal muscle mass and strength, is a frequent precursor to functional impairment, disability, falls, and loss of independence in the elderly. The prevalence of sarcopenia is high, with ≥ 45% of the U.S. population aged 60 years or older sarcopenic. Some possible causative factors include a decline in muscle protein synthesis, inactivity, hormonal changes, pro-inflammatory conditions, and reactive oxygen species within the muscle mitochondria, which may all be exacerbated by inadequate nutritional intake. Since dietary protein is targeted to muscle and muscle mass represents the largest tissue in the body, protein nutrition plays a significant role in muscle metabolism.
SPECIFIC AIMS The specific aim of this proposed study is to determine the effect of PS-IPC supplementation on muscle mass, muscle strength, muscle quality, and inflammatory / immune markers in healthy older adults. Subjects scoring 4 - 10 on the Short-Physical Performance Battery and aged 60-85 years will consume PS-IPC supplements or placebo three times daily for 12 weeks.
HYPOTHESES
- Subjects consuming PS-IPC will have a greater increase in muscle mass and muscle strength compared to a control group consuming a placebo supplement.
- Subjects consuming PS-IPC will demonstrate a greater increase in the fractional rate of muscle protein synthesis compared with a placebo control group.
- Subjects receiving PS-IPC will have a reduction in plasma concentrations of various inflammatory markers of immune function, compared to subjects consuming the placebo.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72205
- University of Arkansas for Medical Sciences
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- BMI of less than or equal to 35 kg/m2, be weight stable (+/- 5 kg) over the previous 4 months (via oral report), report the absence of alcohol or drug abuse, require minimal help in performing activities of daily living, and have a Short Physical Performance Battery score of 4 - 10.
Exclusion Criteria:
- Subjects with acute or chronic disease or who may be using drugs that might interfere with skeletal muscle metabolism / function or immune function will be excluded from participation. Other exclusion criteria include cognitive deficits identified by a Mini-Mental State Examination score < 24, mobility impairment requiring a wheelchair, infections, endocrine diseases (e.g., diabetes or untreated thyroid dysfunction), active inflammatory conditions, autoimmune disorders, renal dysfunction, anemia (hemoglobin < 11.5 g/dL), cardiac problems in preceding 3 months or congestive heart failure, chronic obstructive lung disease, neoplasia other than of the skin during the preceding 5 years, influenza vaccine within last 3 weeks or other vaccines within last 6 weeks, known systemic reaction to any immune function test antigen, and use of the following drugs: immunosuppressants, antianginal agents, antiarrhythmics, antibiotics within last 2 weeks, and oral steroids. Other conditions may be used as inclusion / exclusion criteria at the discretion of the study physician to ensure the safe participation of potential study subjects.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador de placebos: Suplementación con placebo
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Each subject in this study will be provided the PS-IPC dietary supplement or placebo to consume three times per day for the 12-week duration of the intervention.
The placebo supplement will consist of an iso-caloric supplement designed to match the PS-IPC supplement in volume, color, consistency, and palatability.
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Experimental: PS-IPC supplementation
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Each subject in this study will be provided the PS-IPC dietary supplement or placebo to consume three times per day for the 12-week duration of the intervention.
The placebo supplement will consist of an iso-caloric supplement designed to match the PS-IPC supplement in volume, color, consistency, and palatability.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Muscle protein synthesis
Periodo de tiempo: 14-16 months
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14-16 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Body composition
Periodo de tiempo: 14-16 months
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14-16 months
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Skeletal muscle strength and function
Periodo de tiempo: 14-16 months
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14-16 months
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Immune function
Periodo de tiempo: 14-16 months
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14-16 months
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Physical activity level
Periodo de tiempo: 14-16 months
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14-16 months
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Self-perceived quality of life
Periodo de tiempo: 14-16 months
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14-16 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Arny A Ferrando, PhD, University of Arkansas
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
- 109167
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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