SarcopeniaNCT07562698
Ursolic Acid-Standardized Apple Phospholipid-formulated Supplementation for Muscle Strength and Physical Performance in Older Adults With Mild Sarcopenia: A Randomized, Double-Blind, Placebo-Controlled Trial
A study testing Ursolic Acid-Standardized Apple Pomace Extract in people with Sarcopenia, run by Liaquat University of Medical & Health Sciences at 1 site in Pakistan.
Trial 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 Phospholipid-formulated… Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Ursolic Acid-Standardized Apple Pomace Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 sitePakistan
- Study dates
- 10 May 2026to 31 Aug 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Ursolic Acid-Standardized Apple Phospholipid-formulated Supplement on Muscle Strength and Physical Performance in Older Adults With Mild Sarcopenia: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial
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 Phospholipid-formulated 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.
Read the detailed description
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 Phospholipid-formulated supplement 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 patient-reported outcomes such as fatigue and health-related quality of life, and safety assessments including adverse events.
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.
- Conditions
- Sarcopenia
- Being tested
- Ursolic Acid-Standardized Apple Pomace Extract, Placebo
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ursolic Acid-Standardized Apple Pomace ExtractDietary supplement
Also called Apple pomace extract, Ursolic acid supplement
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.
PlaceboOther
Matching placebo tablets identical in appearance, taste, and packaging to the active supplement, administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Ursolic Acid 200 mg/day | Experimental | Participants will receive ursolic acid-standardized apple Phospholipid-formulated supplement 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. Receives: Dietary Supplement: Ursolic Acid-Standardized Apple Pomace Extract; Other: Placebo |
| Ursolic Acid 400 mg/day | Experimental | Participants will receive ursolic acid-standardized apple Phospholipid-formulated supplement 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. Receives: Dietary Supplement: Ursolic Acid-Standardized Apple Pomace Extract |
| Placebo | Active comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in handgrip strength from baseline
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.
Measured: Baseline to Week 12
Secondary outcomes (6)
Change in five-times chair stand test time
Time in seconds required to complete five consecutive chair stands without use of the arms, assessed as change from baseline.
Measured: Baseline to Week 12
Change in Short Physical Performance Battery (SPPB) score
Total SPPB score (range 0-12) assessing lower extremity function, including balance, gait speed, and chair stand performance, evaluated as change from baseline.
Measured: Baseline to Week 12
Change in gait speed
Usual gait speed measured over a 4-meter walk test, expressed in meters per second and evaluated as change from baseline.
Measured: Baseline to Week 12
Change in Timed Up and Go test time
Time in seconds required to stand from a chair, walk 3 meters, turn, return, and sit down, assessed as change from baseline.
Measured: Baseline to Week 12
Change in fatigue severity
Fatigue severity assessed using a validated fatigue severity scale, evaluated as change from baseline.
Measured: Baseline to Week 12
Change in health-related quality of life
Health-related quality of life assessed using the SF-36 physical and mental component summary scores, evaluated as change from baseline.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start10 May 2026
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1:1 ratio to receive either 200 mg/day ursolic acid-standardized apple Phospholipid-formulated 400 mg/day supplementation, or placebo for 12 weeks. Each participant will remain in their assigned group throughout the study period.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Amjad Khan, Liaquat University of Medical & Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562698
- Sponsor's protocol ID
- LUMHS/REC/-1612/30.04.2026
- Status last verified
- Oct 2026
- First submitted
- 24 Apr 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No