SarcopeniaNCT05911516
Pennisetum Purpureum in Sarcopenia Patients
A study testing Pennisetum purpureum in people with Sarcopenia, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
The purpose of this study was to investigate the effects of Pennisetum purpureum health food supplementation on muscle mass and muscle strength. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Pennisetum purpureum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2023to Mar 2024
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult between 18-75 years old
- skeletal muscle mass in extremities by dual-energy X-ray absorptiometry less than 7.0 kg/m2 in men and less than 5.4 kg/m2 in women
- one of the following criteria were met: (1) handgrip strength less than 28 kg in men and less than 18 kg in women and (2) 5-time chair stand test over than 12 seconds
Who cannot join
- The volunteers have history of cardiovascular, liver, kidney, and diabetes mellitus
- acute sport injury
- participated in any clinical trials or experimental research in the last 3 months before our experiment
- taking supplement during the experimental period
- did not maintain their regular eating habit or drink alcohol
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University
Taipei, 110
Ming Ta Yang, Doctorate, 886-2-27361661 ext. 2275, yangrugby@tmu.edu.tw
About this study
Official title: Effects of Pennisetum Purpureum Health Food Supplementation on Muscle Mass and Muscle Strength
The purpose of this study was to investigate the effects of Pennisetum purpureum health food supplementation on muscle mass and muscle strength.
Read the detailed description
All participants performed anthropometric measurements (body height, body weight, BMI, blood pressure, body composition, upper arm circumference, and lower thigh circumference), blood collection (hormones, liver function, and kidney function), exercise test (grip strength and 10-m walking test), as well as questionnaire survey before supplementation. Participants were assigned to either the experimental (n=20) or placebo (n=20) group according to their body composition, upper arm circumference, and lower thigh circumference. The definition of insufficient muscle mass was based on the Asian working group for sarcopenia (AWGS) that skeletal muscle mass in extremities by dual-energy X-ray absorptiometry less than 7.0 kg/m2 in men and less than 5.4 kg/m2 in women is a necessary condition, and one of the following criteria were met: (1) handgrip strength less than 28 kg in men and less than 18 kg in women and (2) 5-time chair stand test over than12 seconds. The anthropometric measurements (body height, body weight, BMI, blood pressure, body composition, upper arm circumference, and lower thigh circumference), blood collection (hormones, liver function, and kidney function), exercise test (grip strength and 10-m walking test), as well as questionnaire survey, were collected after 8 weeks and 12 weeks of supplementation.
- Conditions
- Sarcopenia
- Being tested
- Pennisetum purpureum, Placebo
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pennisetum purpureumDietary supplement
300mg Participants received 900mg of Pennisetum purpureum orally daily for 12 weeks
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Pennisetum purpureum group | Experimental | Not described Receives: Dietary Supplement: Pennisetum purpureum |
| Placebo group | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body height
Measured: Baseline (before supplementation)
Body height
Measured: 8 weeks of supplementation
Body height
Measured: 12 weeks of supplementation
Body weight
Measured: Baseline (before supplementation)
Body weight
Measured: 8 weeks of supplementation
Body weight
Measured: 12 weeks of supplementation
BMI (body mass index)
Measured: Baseline (before supplementation)
BMI (body mass index)
Measured: 8 weeks of supplementation
BMI (body mass index)
Measured: 12 weeks of supplementation
Systolic blood pressure
Measured: Baseline (before supplementation)
Systolic blood pressure
Measured: 8 weeks of supplementation
Systolic blood pressure
Measured: 12 weeks of supplementation
Diastolic blood pressure
Measured: Baseline (before supplementation)
Diastolic blood pressure
Measured: 8 weeks of supplementation
Diastolic blood pressure
Measured: 12 weeks of supplementation
ASM (Appendicular Skeletal Muscle Mass)
Measured: 12 weeks of supplementation
ASM (Appendicular Skeletal Muscle Mass)
Measured: 8 weeks of supplementation
Upper Arm Circumference
Measured: Baseline (before supplementation)
Upper Arm Circumference
Measured: 8 weeks of supplementation
Upper Arm Circumference
Measured: 12 weeks of supplementation
Thigh Circumference
Measured: Baseline (before supplementation)
Thigh Circumference
Measured: 8 weeks of supplementation
Thigh Circumference
Measured: 12 weeks of supplementation
Grip Strength
Measured: Baseline (before supplementation)
Grip Strength
Measured: 8 weeks of supplementation
Grip Strength
Measured: 12 weeks of supplementation
10-Meter Walk Test
Measured: Baseline (before supplementation)
10-Meter Walk Test
Measured: 8 weeks of supplementation
10-Meter Walk Test
Measured: 12 weeks of supplementation
Testosterone level
Measured: Baseline (before supplementation)
Testosterone level
Measured: 8 weeks of supplementation
Testosterone level
Measured: 12 weeks of supplementation
Cortisol level
Measured: Baseline (before supplementation)
Cortisol level
Measured: 8 weeks of supplementation
Cortisol level
Measured: 12 weeks of supplementation
Growth Hormone level
Measured: Baseline (before supplementation)
Growth Hormone level
Measured: 8 weeks of supplementation
Growth Hormone level
Measured: 12 weeks of supplementation
Insulin-like Growth Factor-1
Measured: Baseline (before supplementation)
Insulin-like Growth Factor-1
Measured: 8 weeks of supplementation
Insulin-like Growth Factor-1
Measured: 12 weeks of supplementation
follistain level
Measured: Baseline (before supplementation)
follistain level
Measured: 8 weeks of supplementation
follistain level
Measured: 12 weeks of supplementation
myostain level
Measured: Baseline (before supplementation)
myostain level
Measured: 8 weeks of supplementation
myostain level
Measured: 12 weeks of supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Jun 2023
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
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.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants were assigned to either the experimental (n=20) or placebo (n=20) group according to their body composition, upper arm circumference, and lower thigh circumference.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911516
- Sponsor's protocol ID
- N202305092
- Status last verified
- May 2023
- First submitted
- 26 May 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pennisetum Purpureum Health Food Supplementation on Muscle Mass and Muscle Strength
- ClinicalTrials.gov ID
- NCT05911516
- Acronym / sponsor ID
- N202305092
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 22 Jun 2023 (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.
The purpose of this study was to investigate the effects of Pennisetum purpureum health food supplementation on muscle mass and muscle strength.
Detailed description
All participants performed anthropometric measurements (body height, body weight, BMI, blood pressure, body composition, upper arm circumference, and lower thigh circumference), blood collection (hormones, liver function, and kidney function), exercise test (grip strength and 10-m walking test), as well as questionnaire survey before supplementation. Participants were assigned to either the experimental (n=20) or placebo (n=20) group according to their body composition, upper arm circumference, and lower thigh circumference. The definition of insufficient muscle mass was based on the Asian working group for sarcopenia (AWGS) that skeletal muscle mass in extremities by dual-energy X-ray absorptiometry less than 7.0 kg/m2 in men and less than 5.4 kg/m2 in women is a necessary condition, and one of the following criteria were met: (1) handgrip strength less than 28 kg in men and less than 18 kg in women and (2) 5-time chair stand test over than12 seconds. The anthropometric measurements (body height, body weight, BMI, blood pressure, body composition, upper arm circumference, and lower thigh circumference), blood collection (hormones, liver function, and kidney function), exercise test (grip strength and 10-m walking test), as well as questionnaire survey, were collected after 8 weeks and 12 weeks of supplementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants were assigned to either the experimental (n=20) or placebo (n=20) group according to their body composition, upper arm circumference, and lower thigh circumference.
| Arm | Type | Receives |
|---|---|---|
| Pennisetum purpureum group | Experimental | Dietary Supplement: Pennisetum purpureum |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult between 18-75 years old
- skeletal muscle mass in extremities by dual-energy X-ray absorptiometry less than 7.0 kg/m2 in men and less than 5.4 kg/m2 in women
- one of the following criteria were met: (1) handgrip strength less than 28 kg in men and less than 18 kg in women and (2) 5-time chair stand test over than 12 seconds
Key exclusion criteria (5 listed)
- The volunteers have history of cardiovascular, liver, kidney, and diabetes mellitus
- acute sport injury
- participated in any clinical trials or experimental research in the last 3 months before our experiment
- taking supplement during the experimental period
- did not maintain their regular eating habit or drink alcohol
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 |
|---|---|---|
| Pennisetum purpureum300mg Participants received 900mg of Pennisetum purpureum orally daily for 12 weeks | Dietary supplement | Pennisetum purpureum group |
| PlaceboPlacebo | Dietary supplement | Placebo group |
Primary outcome
Body height
Time frame: Baseline (before supplementation)
Body height
Time frame: 8 weeks of supplementation
Body height
Time frame: 12 weeks of supplementation
Body weight
Time frame: Baseline (before supplementation)
Body weight
Time frame: 8 weeks of supplementation
Body weight
Time frame: 12 weeks of supplementation
BMI (body mass index)
Time frame: Baseline (before supplementation)
BMI (body mass index)
Time frame: 8 weeks of supplementation
BMI (body mass index)
Time frame: 12 weeks of supplementation
Systolic blood pressure
Time frame: Baseline (before supplementation)
Systolic blood pressure
Time frame: 8 weeks of supplementation
Systolic blood pressure
Time frame: 12 weeks of supplementation
Diastolic blood pressure
Time frame: Baseline (before supplementation)
Diastolic blood pressure
Time frame: 8 weeks of supplementation
Diastolic blood pressure
Time frame: 12 weeks of supplementation
ASM (Appendicular Skeletal Muscle Mass)
Time frame: 12 weeks of supplementation
ASM (Appendicular Skeletal Muscle Mass)
Time frame: 8 weeks of supplementation
Upper Arm Circumference
Time frame: Baseline (before supplementation)
Upper Arm Circumference
Time frame: 8 weeks of supplementation
Upper Arm Circumference
Time frame: 12 weeks of supplementation
Thigh Circumference
Time frame: Baseline (before supplementation)
Thigh Circumference
Time frame: 8 weeks of supplementation
Thigh Circumference
Time frame: 12 weeks of supplementation
Grip Strength
Time frame: Baseline (before supplementation)
Grip Strength
Time frame: 8 weeks of supplementation
Grip Strength
Time frame: 12 weeks of supplementation
10-Meter Walk Test
Time frame: Baseline (before supplementation)
10-Meter Walk Test
Time frame: 8 weeks of supplementation
10-Meter Walk Test
Time frame: 12 weeks of supplementation
Testosterone level
Time frame: Baseline (before supplementation)
Testosterone level
Time frame: 8 weeks of supplementation
Testosterone level
Time frame: 12 weeks of supplementation
Cortisol level
Time frame: Baseline (before supplementation)
Cortisol level
Time frame: 8 weeks of supplementation
Cortisol level
Time frame: 12 weeks of supplementation
Growth Hormone level
Time frame: Baseline (before supplementation)
Growth Hormone level
Time frame: 8 weeks of supplementation
Growth Hormone level
Time frame: 12 weeks of supplementation
Insulin-like Growth Factor-1
Time frame: Baseline (before supplementation)
Insulin-like Growth Factor-1
Time frame: 8 weeks of supplementation
Insulin-like Growth Factor-1
Time frame: 12 weeks of supplementation
follistain level
Time frame: Baseline (before supplementation)
follistain level
Time frame: 8 weeks of supplementation
follistain level
Time frame: 12 weeks of supplementation
myostain level
Time frame: Baseline (before supplementation)
myostain level
Time frame: 8 weeks of supplementation
myostain level
Time frame: 12 weeks of supplementation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
Related trials for Sarcopenia
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
MF-300 for Treatment of Age-Related Sarcopenia
Sarcopenia in Elderly
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pennisetum purpureum in people with Sarcopenia, run by Taipei Medical University at 1 site in Taiwan.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 Dec 2023. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming Ta Yang, Doctorate (886-2-27361661 ext. 2275, yangrugby@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body height (time frame: Baseline (before supplementation)). The study lists 47 primary outcomes in all. 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 19 Dec 2023.