SarcopeniaPhase 2NCT06503172
Whole Grain Job's Tear, Muscle Health, Blood Glucose and Lipid Level
A Phase 2 study testing Taiwanese whole grain job's tear (red job's tear) and White job's tear in people with Sarcopenia and Frailty, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Background: This investigation aims to explore efficacy of Taiwanese whole grain job's tear on muscle health and blood glucose and lipid levels in community-dwelling older adults. Read more about this study
- Who is it for?
- Ages 60 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Frailty, Hyperglycemia
- What is being tested?
- Taiwanese whole grain job's tear (red job's tear) and White job's tear
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Jun 2024to Dec 2024
- Phase
- Phase 2
- 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 60 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- People who aged 60-95 years
- Patients with following characteristics:
- feeling loss in activity detecting decline in self's walking speed. feeling tired of doing everything. having fall event in last year. People willing to follow the program and cooperate with us for following tracking.
- People who are neither vegan nor vegetarian People agree and be able to sign the informed consent.
Who cannot join
- People with any disease affecting their limbs, including:
- having fracture on limbs in the past 6 months having severe arthritis in the past 6 months any other whom PI recognized as weak control of their nervous system( e.g.: Parkinson's disease and stroke).
- People with intermittent limp caused by peripheral artery diseases People with weak control of mental disorder People with weak control of Cardiopulmonary disease People with weak control of Malignant tumor People with weak control of kidney diseases (eGFR <60ml/min/1.73) People with Visual impairment and Hearing disorder which cannot help to complete the program.
- People who have underwent hormone treatment and planned to undergo hormone treatment during program session.
- Any other condition that PI recognized as not suitable
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General hospital
Taipei, 112
Anchun Hwang
About this study
Official title: The Clinical Effectiveness of Taiwanese Whole Grain Job's Tear on Muscle Health, Blood Glucose and Lipid Levels- a Randomized Controlled Trial
Background: This investigation aims to explore efficacy of Taiwanese whole grain job's tear on muscle health and blood glucose and lipid levels in community-dwelling older adults.
Methods: An open-label, 16-week, randomized controlled, cross-over trial involving participants with subject complaint of slower gait or weakness or fall in last year were recruited. The intervention group consumed Taiwanese whole grain job's tear (red job's tear) or white job's tear. Assessments included laboratory tests, functional assessments, and body composition.
- Conditions
- Sarcopenia, Frailty, Hyperglycemia, Hyperlipidemia
- Being tested
- Taiwanese whole grain job's tear (red job's tear), White job's tear
- Medical subject headings
- Sarcopenia, Frailty, Hyperglycemia, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taiwanese whole grain job's tear (red job's tear)Biological
300cc drink made from red job's tear, 2 bottle/day from week 0 to week 8
White job's tearBiological
300cc drink made from white job's tear, 2 bottle/day from week 0 to week 8
| Study group | Role | What they receive |
|---|---|---|
| Taiwanese whole grain job's tear (Red job's tear) | Experimental | Taiwanese whole grain job's tear (Red job's tear) Receives: Biological: Taiwanese whole grain job's tear (red job's tear) |
| White job's tear | Active comparator | White job's tear Receives: Biological: White job's tear |
| Active comparator group | Active comparator | Active comparator group
* serve as comparator group from week 0 to week 8,
* assigned to red job's tear or white job's tear group from week 8 to week 16 Receives: Biological: Taiwanese whole grain job's tear (red job's tear); Biological: White job's tear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of appendicular skeletal muscle index(ASMI)
ASMI=appendicular skeletal muscle mass(kg)/(height(m)2)
Measured: 0, 8, 16 week
Changes of handgrip strength
Maximal handgrip strength of dominant hand (kg)
Measured: 0, 8, 16 week
Changes of gait speed
Usual gait speed measured by 6-meter walking (m/s)
Measured: 0, 8, 16 week
Changes of time required to finish timed up and go(TUG) test
Changes of time required to finish timed up and go(TUG) test
Measured: 0, 8, 16 week
Secondary outcomes (6)
Changes of inflammation marker
defined by hsCRP
Measured: 0, 8, 16 week
Changes of insulin resistance
Measured by HOMA-IR
Measured: 0, 8, 16 week
Changes of LDL
Changes of LDL
Measured: 0, 8, 16 week
Changes of muscle biomarker 1
Measured by serum myostatin
Measured: 0, 8 week
Changes of muscle biomarker 2
Measured by serum follistatin
Measured: 0, 8 week
Changes of muscle biomarker 3
Measured by serum activin A
Measured: 0, 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start14 Jun 2024
- Primary completionDec 2024 (estimated)
- Study completionDec 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 Veterans General Hospital, TaiwanThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- Taichung District Agricultural Research and Extension Station, Ministry of Agriculture, Taiwan
- Responsible party
- Sponsor
- Investigators
- Anchun Hwang, Doctor, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503172
- Sponsor's protocol ID
- 2024-04-005C
- Status last verified
- Jul 2024
- First submitted
- 21 Jun 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Effectiveness of Taiwanese Whole Grain Job's Tear on Muscle Health, Blood Glucose and Lipid Levels- a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06503172
- Acronym / sponsor ID
- 2024-04-005C
- Conditions
- Sarcopenia, Frailty, Hyperglycemia, Hyperlipidemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Collaborators
- Taichung District Agricultural Research and Extension Station, Ministry of Agriculture, Taiwan
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 16 Jul 2024 (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.
Background: This investigation aims to explore efficacy of Taiwanese whole grain job's tear on muscle health and blood glucose and lipid levels in community-dwelling older adults.
Methods: An open-label, 16-week, randomized controlled, cross-over trial involving participants with subject complaint of slower gait or weakness or fall in last year were recruited. The intervention group consumed Taiwanese whole grain job's tear (red job's tear) or white job's tear. Assessments included laboratory tests, functional assessments, and body composition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Taiwanese whole grain job's tear (Red job's tear) | Experimental | Biological: Taiwanese whole grain job's tear (red job's tear)Taiwanese whole grain job's tear (Red job's tear) |
| White job's tear | Active comparator | Biological: White job's tearWhite job's tear |
| Active comparator group | Active comparator | Biological: Taiwanese whole grain job's tear (red job's tear), Biological: White job's tearActive comparator group * serve as comparator group from week 0 to week 8, * assigned to red job's tear or white job's tear group from week 8 to week 16 |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- People who aged 60-95 years
- feeling loss in activity detecting decline in self's walking speed. feeling tired of doing everything. having fall event in last year. People willing to follow the program and cooperate with us for following tracking.
- People who are neither vegan nor vegetarian People agree and be able to sign the informed consent.
Key exclusion criteria (5 listed)
- having fracture on limbs in the past 6 months having severe arthritis in the past 6 months any other whom PI recognized as weak control of their nervous system( e.g.: Parkinson's disease and stroke).
- People with intermittent limp caused by peripheral artery diseases People with weak control of mental disorder People with weak control of Cardiopulmonary disease People with weak control of Malignant tumor People with weak control of kidney diseases (eGFR <60ml/min/1.73) People with Visual impairment and Hearing disorder which cannot help to complete the program.
- People who have underwent hormone treatment and planned to undergo hormone treatment during program session.
- Any other condition that PI recognized as not suitable
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 |
|---|---|---|
| Taiwanese whole grain job's tear (red job's tear)300cc drink made from red job's tear, 2 bottle/day from week 0 to week 8 | Biological | Active comparator group, Taiwanese whole grain job's tear (Red job's tear) |
| White job's tear300cc drink made from white job's tear, 2 bottle/day from week 0 to week 8 | Biological | Active comparator group, White job's tear |
Primary outcome
Changes of appendicular skeletal muscle index(ASMI)
Time frame: 0, 8, 16 week
ASMI=appendicular skeletal muscle mass(kg)/(height(m)2)
Changes of handgrip strength
Time frame: 0, 8, 16 week
Maximal handgrip strength of dominant hand (kg)
Changes of gait speed
Time frame: 0, 8, 16 week
Usual gait speed measured by 6-meter walking (m/s)
Changes of time required to finish timed up and go(TUG) test
Time frame: 0, 8, 16 week
Changes of time required to finish timed up and go(TUG) test
6 secondary outcomes
Changes of inflammation marker
Time frame: 0, 8, 16 week
Changes of insulin resistance
Time frame: 0, 8, 16 week
Changes of LDL
Time frame: 0, 8, 16 week
Changes of muscle biomarker 1
Time frame: 0, 8 week
Changes of muscle biomarker 2
Time frame: 0, 8 week
Changes of muscle biomarker 3
Time frame: 0, 8 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Anchun Hwang, Doctor principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Taiwanese whole grain job's tear (red job's tear) and White job's tear in people with Sarcopenia and Frailty, run by Taipei Veterans General Hospital, Taiwan 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 4 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 16 Jul 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Anchun Hwang, Doctor (886-2-28712121, anchun.hwang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of appendicular skeletal muscle index(ASMI) (time frame: 0, 8, 16 week). The study lists 4 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 16 Jul 2024.