- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07586839
Effect of a Nutritional Supplement on Muscle Recovery (RECOVER)
7 de mayo de 2026 actualizado por: Marlou Dirks, Wageningen University
The Role of a Nutritional Formulation Containing Caprylic Acid and Omega 3 Fatty Acids in Promoting Skeletal Muscle Function Recovery to Damaging Exercise in Healthy, Young Volunteers
The aim is to develop a food supplement drink that supports muscle health by combining specific fatty acids, which can positively affect metabolic and inflammation processes that are important for muscle health.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Descripción detallada
This study will assess the effects of a vegan nutritional formulation containing caprylic acid and omega-3 fatty acids on recovery from muscle-damaging exercise.
The goal is to determine whether this supplement can mitigate muscle damage, reduce inflammation, and accelerate functional recovery, thereby supporting long-term muscle health and functional independence.
This research has the potential to reveal a novel approach to muscle health management, contributing to the development of safe and effective nutritional strategies that support healthy aging.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
28
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.
Estudio Contacto
- Nombre: Silvie Timmers, PhD
- Número de teléfono: +31 317-484 136
- Correo electrónico: silvie.timmers@wur.nl
Ubicaciones de estudio
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Gelderland
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Wageningen, Gelderland, Países Bajos, 6708WD
- Reclutamiento
- Wageningen University and Research
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Contacto:
- Human and Animal Physiology
- Número de teléfono: +31317484136
- Correo electrónico: office.hap@wur.nl
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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
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Young (≥18 and ≤35 years)
- Male sex
- Non-obese (≥18.5 and ≤27.5 kg/m2)
- Recreationally active (performing non-competitive exercise at least one time a week for minimally 30 minutes)
Exclusion Criteria:
- Smoking
- Participation in structural exercise with a major eccentric component (e.g. soccer, basketball, trail running, etc…)
- Chronic use of any prescribed over the counter pharmaceuticals
- Any history of medical or surgical events that may effect the study outcomes
- Following a specific diet (e.g. weight loss, ketogenic, vegan)
- Taking protein supplements
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: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Testdrink
Drink containing caprylic acid and omega-3 fatty acids
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Seven day supplementation with a muscle damaging exercise performed on day four
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Comparador de placebos: Control drink
Control drink that differs in fatty acid composition
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Seven day supplementation with a muscle damaging exercise performed on day four
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in isometric muscle strength of the vastus lateralis muscle on a muscle dynamometer before and 72h after damaging exercise
Periodo de tiempo: The change in muscle strength will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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The main study endpoint is the change in skeletal muscle function recovery from a single bout of damaging eccentric exercise between an emulsion containing caprylic acid and omega 3 fatty acids, compared to a control emulsion, from before exercise (t=0) to 72 hours post-exercise.
Skeletal muscle function will be measured as maximal voluntary isometric muscle strength of the vastus lateralis muscle on a muscle dynamometer.
The maximal voluntary strength is expressed as maximal voluntary contraction (Newtons).
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The change in muscle strength will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in muscle fatigue from before until 72 hours after damaging exercise measured with electrical stimulation on a muscle dynamometer
Periodo de tiempo: The change in fatigue resistance will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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The change in muscle fatigue recovery from a single bout of damaging eccentric exercise between an emulsion containing caprylic acid and omega 3 fatty acids compared to a control emulsion will be examined by means of a two-minute fatigue inducing protocol on a skeletal muscle dynamometer.
Every other second during two minutes, electrically induced muscle contractions will be evoked on the vastus lateralis muscle at 40% of the maximal voluntary muscle strength.
The percental decline in muscle force (N) generating capacity will be monitored as indicator of fatigue resistance.
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The change in fatigue resistance will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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Change in muscle soreness from before until up to 72 hours after a damaging exercise using a VAS-Scale and soreness questionnaire
Periodo de tiempo: The change in muscle soreness will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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The change in muscle soreness from a single bout of eccentric exercise between an emulsion containing caprylic acid and omega 3 fatty acids, compared to a control emulsion will be measured by means of a VAS-Scale, measuring current muscle soreness, as well as a retrospective pain questionnaire, measuring muscle soreness over the preceding 24 hours.
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The change in muscle soreness will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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Plasma creatine kinase concentrations before and up to 72 hours after damaging exercise in blood
Periodo de tiempo: The change in plasma creatine kinase will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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The change in creatine kinase concentrations from a single bout of eccentric exercise between an emulsion containing caprylic acid and omega 3 fatty acids, compared to a control emulsion, will be measured using commercially available kits.
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The change in plasma creatine kinase will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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Plasma cholesterol concentrations before and up to 72 hours after damaging exercise in blood
Periodo de tiempo: The change in plasma cholesterol concentrations will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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The change in plasma cholesterol concentrations from a single bout of eccentric exercise between an emulsion containing caprylic acid and omega 3 fatty acids, compared to a control emulsion, will be measured using commercially available kits
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The change in plasma cholesterol concentrations will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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Plasma triglyceride concentrations before and up to 72 hours after damaging exercise in blood
Periodo de tiempo: The change in plasma triglycerides will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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The change in plasma triglyceride concentrations from a single bout of eccentric exercise between an emulsion containing caprylic acid and omega 3 fatty acids, compared to a control emulsion, will be measured using commercially available kits.
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The change in plasma triglycerides will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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Plasma beta-hydroxybutyrate concentrations before and up to 72 hours after damaging exercise in blood
Periodo de tiempo: The change in plasma beta-hydroxybutyrate will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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The change in plasma beta-hydroxybutyrate concentrations from a single bout of eccentric exercise between an emulsion containing caprylic acid and omega 3 fatty acids, compared to a control emulsion, will be measured using commercially available kits.
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The change in plasma beta-hydroxybutyrate will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 (Actual)
26 de septiembre de 2025
Finalización primaria (Estimado)
1 de junio de 2026
Finalización del estudio (Estimado)
1 de septiembre de 2026
Fechas de registro del estudio
Enviado por primera vez
21 de febrero de 2025
Primero enviado que cumplió con los criterios de control de calidad
7 de mayo de 2026
Publicado por primera vez (Actual)
14 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
7 de mayo de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NL88300.028.24
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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