Ursolic Acid-Standardized Apple Pomace Supplementation for Muscle Strength and Physical Performan… (NCT07562698) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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
105 participantsStarted 2026-05-10
Plain-language summary
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.
Who can participate
Age range65 Years – 80 Years
SexALL
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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 mus…
What they're measuring
1
Change in handgrip strength from baseline
Timeframe: Baseline to Week 12
Trial details
NCT IDNCT07562698
SponsorLiaquat University of Medical & Health Sciences