Los Efectos de PeptiStrong y Suero de Leche en la Función Muscular en Adultos Mayores
Los Efectos de PeptiStrong y Proteína de Suero en Dosis Baja frente a Proteína de Suero en Dosis Alta Sola sobre la Función Muscular en Adultos Mayores
Examining the effects of PeptiStrong and protein on muscle function in older adults
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
The aim of this study is to compare two protein drinks containing whey protein (derived from milk) in healthy adults aged 60 to 85 years. One group will consume a standard whey protein drink (20g), while the other group will consume a drink with half the total protein dose (10g) made of whey protein and PeptiStrong, a fava bean hydrolysate containing bioactive peptides.
The study will assess whether the lower protein drink containing PeptiStrong will lead to equal or greater improvements than the standard drink in physical function, such as the ability to stand up from a chair, walk at a normal pace, maintain balance, and grip strength. The study will also examine markers related to inflammation, fatigue, and quality of life.
The intended value of this research is to improve understanding of how targeted nutritional strategies may help maintain or improve muscle function in older adults. The findings may help inform future nutritional recommendations and the development of practical dietary interventions aimed at supporting healthy ageing and independence.
Tipo de estudio
Tipo de estudio
Inscripción (Actual)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Liverpool, Reino Unido, L3 3AF
- LJMU, Byrom Street
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Men and women aged 60 to 85 years at the time of enrolment
- Community-dwelling (living independently or with minimal assistance)
- Able to walk independently (with or without a walking aid) and complete simple physical function tests (such as standing up from a chair and walking short distances)
- Willing and able to attend two study visits at the research facility (baseline and end of study)
- Willing and able to consume a protein drink containing whey protein (derived from milk) once daily for 30 days
- Able to understand the study information and provide written informed consent
Exclusion Criteria:
- Any known food allergy or intolerance to fava bean protein or milk protein
- Diagnosed kidney disease or any medical condition where increased protein intake is contraindicated
- Yes to any of the answers on the "Older Adult Functional Assessment Screening Questionnaire"
- Individuals with implanted electronic devices
- Current or recent (within the past 3 months) participation in another clinical research study involving a nutritional or exercise intervention
- Conditions that significantly impair mobility or balance such that safe completion of the physical function tests is not possible
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
|
Experimental: PeptiStrong + whey protein
2.4g PeptiStrong (provides 1.6g protein) + 8.4g of whey protein = 10g total protein |
Fava bean protein hydrolysate containing bioactive peptides mixed with whey protein as dry powder for drinkable protein shake |
|
Comparador activo: Whey protein
20g whey protein |
Whey protein as dry powder for drinkable protein shake |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Hand Grip Strength via hand held dynamometer
Periodo de tiempo: Baseline to Week 4
|
Change from baseline to end of study in grip strength as assessed via hand held dynamometer |
Baseline to Week 4
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Chair Stand Test - Part of short performance physical battery
Periodo de tiempo: Baseline to week 4
|
Change from baseline to end of study in physical function assessment via chair stands. This test measures the time taken to complete 5 sit-to-stand repetitions in seconds. A lower time (fewer seconds) = better performance. As part of the full short performance physical battery it is converted to a subscore of 0-4, where a higher score = better performance |
Baseline to week 4
|
|
Gait Speed as part of short performance physical battery
Periodo de tiempo: Baseline to week 4
|
Change from baseline to end of study in physical function assessment assessed as time to walk a fixed distance in seconds and reporting in meters per second. Higher speeds indicate better performance. This is converted to a subscore of 0-4 within the full short performance physical battery |
Baseline to week 4
|
|
6 Minute Walking Endurance Test
Periodo de tiempo: Baseline to week 4
|
Change from baseline to end of study in physical function and endurance assessed as the total distance walked in 6 minutes in meters. A greater distance reflects better walking endurance and functional capacity. |
Baseline to week 4
|
|
Balance test as part of short performance physical battery
Periodo de tiempo: Baseline to week 4
|
Change from baseline to end of study in balance as assessed by the ability to hold three standing positions of increasing difficulty: side-by-side, semi-tandem, and tandem stance in seconds. Higher scores indicate better balance. The overall score is converted to a a sub-score of 0-4 within the full short performance physical battery. |
Baseline to week 4
|
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Balance assessment via force plates
Periodo de tiempo: Baseline to week 4
|
Change from baseline to end of study in balance as assessed via force plates |
Baseline to week 4
|
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Quality of Life via the Sarcopenia Quality of Life (SarQoL®) Questionnaire
Periodo de tiempo: Baseline to week 4
|
Change from baseline to end of study in quality of life as measured via subjective SarQOL questionnaire. The total score ranges from 0 to 100, with higher scores reflecting a higher quality of life. |
Baseline to week 4
|
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Fatigue via Multidimensional Fatigue Inventory Questionnaire
Periodo de tiempo: Baseline to week 4
|
Change from baseline to end of study in self-reported fatigue as assessed via multidimensional fatigue inventory questionnaire. This 20-item questionnaire covers five dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation, and Reduced Activity. Each subscale score ranges from 4 to 20, with higher scores indicating greater fatigue |
Baseline to week 4
|
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C-reactive protein (CRP) via blood test
Periodo de tiempo: Baseline to week 4
|
Change from baseline to the end of study in inflammatory marker C-reactive protein (CRP) in serum as mg/L |
Baseline to week 4
|
|
Interleukins via blood test
Periodo de tiempo: Baseline to week 4
|
Change from baseline to the end of study in Interleukin inflammatory markers in serum as pg/mL |
Baseline to week 4
|
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Body composition: Muscle mass and body fat via bioelectrical impedance analysis
Periodo de tiempo: Baseline to week 4
|
Change from baseline to end of study in muscle mass and body fat as measured by bioelectrical impedance analysis in kilograms and % of total body weight |
Baseline to week 4
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
Investigadores
- Investigador principal: Graeme Close, Professor, Liverpool John Moore University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- PEPVFH+60/26
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.
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