Ursolic Acid-Standardized Apple Pomace Supplementation for Muscle Strength and Physical Performance in Older Adults With Mild Sarcopenia: A Randomized, Double-Blind, Placebo-Controlled Trial
Effects of Ursolic Acid-Standardized Apple Pomace Extract Formulated With Phospholipids on Muscle Strength and Physical Performance in Older Adults With Mild Sarcopenia: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Sarcopenia is an age-related skeletal muscle disorder characterized by progressive decline in muscle strength and physical performance, resulting in increased risk of falls, disability, and loss of independence. Despite its clinical relevance, no pharmacological therapies are currently approved, and management relies primarily on exercise and nutritional strategies, which may be insufficient or impractical for many individuals.
Ursolic acid is a naturally occurring triterpenoid found in apple peel and other plant sources, with preclinical evidence demonstrating beneficial effects on skeletal muscle mass, strength, and metabolic function. These effects have been linked to modulation of anabolic signaling pathways, including insulin and insulin-like growth factor-1 pathways, as well as suppression of muscle atrophy-related genes. Human studies remain limited, particularly in older adults with sarcopenia.
This study is a randomized, double-blind, placebo-controlled, parallel-group clinical trial designed to evaluate the effects of ursolic acid-standardized apple pomace extract formulated with phospholipids on muscle strength and physical performance in older adults with mild sarcopenia. A total of 105 participants will be randomized in a 1:1:1 ratio to receive either 200 mg/day, 400 mg/day of the active supplement, or placebo for 12 weeks.
The primary endpoint is change in handgrip strength from baseline to Week 6 and Week 12. Key secondary endpoints include measures of lower-limb functional strength and physical performance, including five-times chair stand test, Short Physical Performance Battery score, gait speed, and Timed Up and Go test. Additional outcomes include body composition assessed by bioelectrical impedance analysis, patient-reported outcomes such as fatigue and health-related quality of life, and safety assessments including adverse events and laboratory parameters.
The study is conducted in accordance with Good Clinical Practice and the Declaration of Helsinki, and aims to provide clinical evidence on the efficacy and safety of ursolic acid supplementation in a population with clinically relevant muscle function impairment.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Jāmshoro, Pakistán, 76090
- Liaquat University Hospitals
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age 65 to 80 years (inclusive)
- Male or female
- Community-dwelling outpatients
- Able and willing to provide written informed consent
- Able to comply with study procedures and attend scheduled visits
- Able to walk independently (assistive devices permitted) and safely perform physical performance assessments
- Stable medical condition and stable medication regimen for at least 4 weeks prior to screening
- Mild sarcopenia defined as:
- SARC-F score ≥4 or clinical suspicion of sarcopenia, and
Low muscle strength defined as:
Handgrip strength <27 kg for men or <16 kg for women, or Five-times chair stand test >15 seconds or inability to complete without use of arms
- Eligible for body composition assessment using bioelectrical impedance analysis (BIA)
Exclusion Criteria:
- Severe sarcopenia or severe functional impairment precluding safe participation
- Unstable or uncontrolled medical conditions that may interfere with participation or safety
- Severe renal or hepatic disease, including:
- eGFR <30 mL/min/1.73 m²
- Significant liver disease or markedly abnormal liver function tests
- Uncontrolled endocrine or metabolic disorders
- Active malignancy or ongoing cancer treatment
- Use of medications affecting muscle mass or function, including:
- Chronic systemic corticosteroids
- Anabolic steroids or testosterone therapy
- Other investigational muscle-modifying agents
- Recent structured resistance training within the past 3 months
- Use of muscle-targeted supplements (e.g., creatine, HMB) within the previous 4-8 weeks
- Contraindications to BIA (e.g., pacemaker or implanted electronic device)
- Acute illness within 4 weeks prior to screening
- Cognitive impairment preventing informed consent or protocol compliance
- Known allergy or intolerance to ursolic acid or study product components
- Any condition that, in the opinion of the investigator, may compromise safety, compliance, or data integrity
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Ursolic Acid 200 mg/day
Participants will receive ursolic acid-standardized apple pomace extract tablets at a total daily dose of 200 mg for 12 weeks.
The dosing regimen consists of one 200 mg active tablet taken at breakfast and one placebo tablet taken at dinner.
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Oral supplementation with ursolic acid-standardized apple pomace extract formulated with phospholipids.
The product is standardized to contain triterpenes including ursolic acid and is administered as tablets.
Otros nombres:
Matching placebo tablets identical in appearance, taste, and packaging to the active supplement, administered orally.
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Experimental: Ursolic Acid 400 mg/day
Participants will receive ursolic acid-standardized apple pomace extract tablets at a total daily dose of 400 mg for 12 weeks.
The dosing regimen consists of one 200 mg active tablet taken at breakfast and one 200 mg active tablet taken at dinner.
|
Oral supplementation with ursolic acid-standardized apple pomace extract formulated with phospholipids.
The product is standardized to contain triterpenes including ursolic acid and is administered as tablets.
Otros nombres:
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Comparador activo: Placebo
Participants will receive matching placebo tablets identical in appearance to the active supplement, administered as one tablet at breakfast and one tablet at dinner for 12 weeks.
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Matching placebo tablets identical in appearance, taste, and packaging to the active supplement, administered orally.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in handgrip strength from baseline
Periodo de tiempo: Baseline to Week 12
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Handgrip strength will be measured in kilograms using a calibrated hand dynamometer.
The best value from three attempts on the dominant hand in a standardized seated position will be recorded.
The outcome represents the change from baseline.
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Baseline to Week 12
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in five-times chair stand test time
Periodo de tiempo: Baseline to Week 12
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Time in seconds required to complete five consecutive chair stands without use of the arms, assessed as change from baseline.
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Baseline to Week 12
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Change in Short Physical Performance Battery (SPPB) score
Periodo de tiempo: Baseline to Week 12
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Total SPPB score (range 0-12) assessing lower extremity function, including balance, gait speed, and chair stand performance, evaluated as change from baseline.
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Baseline to Week 12
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Change in gait speed
Periodo de tiempo: Baseline to Week 12
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Usual gait speed measured over a 4-meter walk test, expressed in meters per second and evaluated as change from baseline.
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Baseline to Week 12
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Change in Timed Up and Go test time
Periodo de tiempo: Baseline to Week 12
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Time in seconds required to stand from a chair, walk 3 meters, turn, return, and sit down, assessed as change from baseline.
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Baseline to Week 12
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Change in body composition
Periodo de tiempo: Baseline to Week 12
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Body composition parameters assessed by bioelectrical impedance analysis, including skeletal muscle mass, skeletal muscle index, and fat mass, evaluated as change from baseline.
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Baseline to Week 12
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Change in fatigue severity
Periodo de tiempo: Baseline to Week 12
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Fatigue severity assessed using a validated fatigue severity scale, evaluated as change from baseline.
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Baseline to Week 12
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Change in health-related quality of life
Periodo de tiempo: Baseline to Week 12
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Health-related quality of life assessed using the SF-12 physical and mental component summary scores, evaluated as change from baseline.
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Baseline to Week 12
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (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
- LUMHS/REC/-1612/30.04.2026
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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