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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Change in handgrip strength from baseline
研究概览
简要总结
Sarcopenia is an age-related condition characterized by loss of muscle strength and physical performance, leading to increased risk of falls and disability. This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the effects of ursolic acid-standardized apple pomace supplementation on muscle strength and physical performance in older adults with mild sarcopenia. Participants will be randomly assigned to receive either 200 mg/day, 400 mg/day of the supplement, or placebo for 12 weeks. The primary outcome is change in handgrip strength, with additional assessments of physical performance, body composition, fatigue, and quality of life. The study will also evaluate the safety and tolerability of the intervention.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This is a double-blind study in which participants, care providers, investigators, and outcome assessors are blinded to treatment allocation. Study products and placebo are identical in appearance, packaging, and administration schedule. Unblinding is permitted only in case of medical necessity.
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Ursolic Acid-Standardized Apple Pomace Extract (Dietary Supplement)
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.
干预措施: Ursolic Acid-Standardized Apple Pomace Extract (Dietary Supplement)
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.
干预措施: Placebo (Other)
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.
干预措施: Placebo (Other)
结局指标
主要结局
Change in handgrip strength from baseline
时间窗: Baseline to Week 12
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.
次要结局
- Change in five-times chair stand test time(Baseline to Week 12)
- Change in Short Physical Performance Battery (SPPB) score(Baseline to Week 12)
- Change in gait speed(Baseline to Week 12)
- Change in Timed Up and Go test time(Baseline to Week 12)
- Change in body composition(Baseline to Week 12)
- Change in fatigue severity(Baseline to Week 12)
- Change in health-related quality of life(Baseline to Week 12)
研究者
Dr. Amjad Khan
Professor
Liaquat University of Medical & Health Sciences