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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07562698
- Acronym / sponsor ID
- LUMHS/REC/-1612/30.04.2026
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Study start
- 10 May 2026 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ursolic Acid 200 mg/day | Experimental | Dietary Supplement: Ursolic Acid-Standardized Apple Pomace Extract, Other: PlaceboParticipants 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. |
| Ursolic Acid 400 mg/day | Experimental | Dietary Supplement: Ursolic Acid-Standardized Apple Pomace ExtractParticipants 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. |
| Placebo | Active comparator | Other: PlaceboParticipants 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. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ursolic Acid-Standardized Apple Pomace ExtractAlso: Apple pomace extract, Ursolic acid supplementOral 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. | Dietary supplement | Ursolic Acid 200 mg/day, Ursolic Acid 400 mg/day |
| PlaceboMatching placebo tablets identical in appearance, taste, and packaging to the active supplement, administered orally. | Other | Placebo, Ursolic Acid 200 mg/day |
Primary outcome
Change in handgrip strength from baseline
Time frame: 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.
6 secondary outcomes
Change in five-times chair stand test time
Time frame: Baseline to Week 12
Change in Short Physical Performance Battery (SPPB) score
Time frame: Baseline to Week 12
Change in gait speed
Time frame: Baseline to Week 12
Change in Timed Up and Go test time
Time frame: Baseline to Week 12
Change in fatigue severity
Time frame: Baseline to Week 12
Change in health-related quality of life
Time frame: Baseline to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in handgrip strength from baseline (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.