Sport NutritionNCT05909475
Supplementation With GKEX Sports Probiotic Combo for Muscle Gain and Fat Loss Assessment
A study testing GKEX in people with Sport Nutrition and Probiotic, run by National Taiwan Sport University at 1 site in Taiwan.
Trial summary
Objective: To discuss the "GKEX Sports Probiotics Combination (hereinafter referred to as GKEX)", a product commissioned by Grape King Biotechnology Co., Ltd., and its effects on increasing muscle mass, muscle strength, physical performance and improving body composition when combined with resistance exercise… Read more about this study
- Who is it for?
- Ages 20 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Sport Nutrition, Probiotic
- What is being tested?
- GKEX
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Jul 2022to 24 Dec 2022
- 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 20 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The tissues and organs of the body are functioning normally
- no disease, fatigue, or weakness
- independent and flexible activities
Who cannot join
- With a history of cardiovascular disease, hypertension, metabolic disease, asthma or cancer diagnosed by a physician
- BMI≧27
- Who have taken anti-inflammatory analgesics or acute and chronic diseases within one month, etc.,
- The students and related stakeholders guided by the host of this plan
- Who have the habit of smoking and drinking
- Within two weeks Have used probiotic products in powder, capsule or tablet form (including yogurt, yogurt, Yakult and other related foods)
- Food or allergic to lactic acid bacteria products
- Have had hepatobiliary and gastrointestinal surgery within 2 years (except hernia and polypectomy)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Graduate Institute of Sports Science, National Taiwan Sport University
Taoyuan, 33301
About this study
Objective: To discuss the "GKEX Sports Probiotics Combination (hereinafter referred to as GKEX)", a product commissioned by Grape King Biotechnology Co., Ltd., and its effects on increasing muscle mass, muscle strength, physical performance and improving body composition when combined with resistance exercise training. Method: The experiment adopts a double-blind design. After screening, 52 subjects (20 males and 32 females) were randomly divided into two groups, each with 10 males and 16 females: (1) placebo without GKEX probiotics Capsule group (Placebo) (2 capsules/day), (2) GKEX group (GKEX) (1x1010 CFU/capsule, 2 capsules/day). All subjects received daily supplementation samples for 6 weeks and received resistance exercise training three times a week. Before the intervention and 6 weeks after the intervention, the diet evaluation, systemic and resistive body composition, muscle ultrasound, muscle strength, maximum oxygen uptake, explosive power, anaerobic power, etc. were detected respectively.
- Conditions
- Sport Nutrition, Probiotic
- Being tested
- GKEX, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GKEXDietary supplement
GKEX group. Probiotic capsules contain 10 billion CFU (colony forming units) of GKEX, , 2 caps daily use.
PlaceboOther
The placebo capsule contains microcrystalline cellulose, 2 caps daily use.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The placebo capsule contains microcrystalline cellulose, 2 caps daily use. Receives: Other: Placebo |
| GKEX | Experimental | GKEX group. Probiotic capsules contain 10 billion CFU (colony forming units) of GKEX, , 2 caps daily use. Receives: Dietary Supplement: GKEX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isometric Mid-Thigh Pull (IMTP_RFD
Customized IMTP test equipment and two force plates (type 9287BA, Kistler Instruments AG, Winterthur, Switzerland) were used. All participants stood with their feet the same width apart, and the rod was placed between the thighs, with the torso upright, the spine neutral, and the knee and hip angles at 140°, to familiarize the participants with the IMPT test method. The average absolute peak rate of force development (RFD) parameters were recorded.
Measured: up to 6 weeks
Isometric Mid-Thigh Pull (IMTP)_relative peak force
Customized IMTP test equipment and two force plates (type 9287BA, Kistler Instruments AG, Winterthur, Switzerland) were used. All participants stood with their feet the same width apart, and the rod was placed between the thighs, with the torso upright, the spine neutral, and the knee and hip angles at 140°, to familiarize the participants with the IMPT test method. The average absolute peak rate of force development (RFD) parameters were recorded.
Measured: up to 6 weeks
Wingate Anaerobic Test (WAnT)_relative peak power
After a standard warm-up, all subjects were assessed with the classical WAnT on a cycloergometer (Monark 894E, Varberg, Sweden) in a 30 s "go all out" ultramax test. The seat height was adjusted to the satisfaction of each participant, and toe clips prevented the feet from slipping off the pedals. Before the initial test, the subjects warmed up for 5 min, and the power was approximately 50 W. After the warm-up, two preparation exercises lasting 3 s, during which the actual test load was 3% of their own body weight, were applied to accustom the participant to resistance. The test started, and the resistance was set on the friction belt of the dynamometer. External loading was estimated individually at 5% body weight. The average relative peak power parameters were recorded.
Measured: up to 6 weeks
Wingate Anaerobic Test (WAnT)_relative mean power
After a standard warm-up, all subjects were assessed with the classical WAnT on a cycloergometer (Monark 894E, Varberg, Sweden) in a 30 s "go all out" ultramax test. The seat height was adjusted to the satisfaction of each participant, and toe clips prevented the feet from slipping off the pedals. Before the initial test, the subjects warmed up for 5 min, and the power was approximately 50 W. After the warm-up, two preparation exercises lasting 3 s, during which the actual test load was 3% of their own body weight, were applied to accustom the participant to resistance. The test started, and the resistance was set on the friction belt of the dynamometer. External loading was estimated individually at 5% body weight. The average relative mean power parameters were recorded.
Measured: up to 6 weeks
Wingate Anaerobic Test (WAnT)_fatigue index
After a standard warm-up, all subjects were assessed with the classical WAnT on a cycloergometer (Monark 894E, Varberg, Sweden) in a 30 s "go all out" ultramax test. The seat height was adjusted to the satisfaction of each participant, and toe clips prevented the feet from slipping off the pedals. Before the initial test, the subjects warmed up for 5 min, and the power was approximately 50 W. After the warm-up, two preparation exercises lasting 3 s, during which the actual test load was 3% of their own body weight, were applied to accustom the participant to resistance. The test started, and the resistance was set on the friction belt of the dynamometer. External loading was estimated individually at 5% body weight. The average fatigue index parameters were recorded.
Measured: up to 6 weeks
The Countermovement Jump (CMJ) Test
The CMJ test is a practical, effective, reliable, and simple method of measuring lower limb strength, which is related to the maximum speed, strength and explosive force of the lower limbs. For this test, participants stood on the Kistler force measurement platform (9260AA, Kistler Co., Ltd., Switzerland) on both feet and performed to inspection. During the test, they were asked to put their hands on their hips and remain on the platform. After that, they were asked to squat down until the knees bent 90 degrees and then to immediately jump as high as possible. The average power (MF), were recorded during the jump. Each participant repeated the test 3 times, and CMJ data were obtained at the designated points. The instrument was calibrated for each individual's weight.
Measured: up to 6 weeks
VO2max
To evaluate the maximum oxygen consumption and exercise performance, we used a treadmill (Pulsar, h/p/cosmos, Nussdorf-Traunstein, Germany) and an automatic breathing analyzer (Vmax 29c, Sensor Medics, Yorba Linda, CA, USA). In addition, a polar heart rate device was used to monitor the heart rate (HR). The speed range of the treadmill was set to 7.2 km/h and increased by 1.8 km/h every 2 min until fatigue, according to Bruce's protocol. When the breathing exchange rate (the volume ratio of carbon dioxide produced to oxygen consumed, VCO2/VO2) was higher than 1.10 and reached the maximum heart rate (maximum heart rate = 220 - age), oxygen consumption was considered to be maximum. The three highest VO2max peak were averaged to obtain the VO2max values of the individual volunteers.
Measured: up to 6 weeks
Muscle composition_muscle thickness
Use muscular ultrasound (BenQ T3300) to scan muscle thickness
Measured: up to 6 weeks
Muscle composition_fascia thickness
Use muscular ultrasound (BenQ T3300) to scan fascia thickness
Measured: up to 6 weeks
dual-energy X-ray absorptiometry, DXA
A non-invasive dual-energy X-ray absorptive bone density testing room (Lunar iDXA, GE Healthcare, Chicago, IL, USA) was used for systemic body composition and bone density measurements. The subject was required to lie flat on the test bed, with their body at the center line, and their limbs within the detection range. Two different energy X-rays were used to scan the inspected part, then the scintillation detector received the X-rays that had penetrated the inspected part, and analyzed the obtained muscle mass
Measured: up to 6 weeks
Body composition_body fat
The multi-frequency principle was applied to measure body composition by using a bioelectrical impedance analyzer (BIA) on an InBody 570 device (In-body, Seoul, South Korea). To perform the measurements, after the subjects' palms and soles were removed from the sensors, the subjects stood on the footing electrodes and held the sensing handles with two hands. During the measurements, the subjects kept their arms open and left their bodies at an angle of 30° without speaking or moving. The subjects also fasted for at least 8 h before the test. The body fat were meansure
Measured: up to 6 weeks
Body composition_muscle mass
The multi-frequency principle was applied to measure body composition by using a bioelectrical impedance analyzer (BIA) on an InBody 570 device (In-body, Seoul, South Korea). To perform the measurements, after the subjects' palms and soles were removed from the sensors, the subjects stood on the footing electrodes and held the sensing handles with two hands. During the measurements, the subjects kept their arms open and left their bodies at an angle of 30° without speaking or moving. The subjects also fasted for at least 8 h before the test. The muscle mass were meansure
Measured: up to 6 weeks
Grip strength
Use the armed grip machine (T.K.K.5401, Takei Scientific Instruments Co.,Ltd, Niigata, Japan) to measure, hold each of the left and right hands three times until they are weak, and record the maximum value
Measured: up to 6 weeks
Secondary outcomes (10)
Safety assessment - AST
Safety is assessed function of liver such as AST (8-38 IU/L).
Measured: up to 6 weeks
Safety assessment - ALT
Safety is assessed function of liver such as ALT (4-44 IU/L).
Measured: up to 6 weeks
Safety assessment - T-Cholesterol
Safety is assessed function of blood lipid such as T-Cholesterol (<200 mg/dL).
Measured: up to 6 weeks
Safety assessment - Uric Acid
Safety is assessed function of kidney such as Uric Acid (3.4-7.6 mg/dl)
Measured: up to 6 weeks
Safety assessment - BUN
Safety is assessed function of kidney such as Bun (6-20 mg/dl)
Measured: up to 6 weeks
Safety assessment - Creatinine
Safety is assessed function of kidney such as Creatinine (0.6-1.3 mg/dl)
Measured: up to 6 weeks
Safety assessment - Glucose
Safety is assessed function of Glucose (70~100 mg/dL)
Measured: up to 6 weeks
Safety assessment - Triglycerides
Safety is assessed function of blood lipid such as Triglycerides (<150 mg/dL)
Measured: up to 6 weeks
Safety assessment - LDL
Safety is assessed function of blood lipid such as LDL (0~140mg/dl)
Measured: up to 6 weeks
Safety assessment - HDL
Safety is assessed function of blood lipid such as HDL (>40mg/dl)
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start4 Jul 2022
- Primary completion24 Dec 2022
- Study completion24 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sport NutritionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan Sport University
- Sponsor type
- University, hospital or other
- Collaborators
- Grape King Bio Ltd.
- Responsible party
- Principal investigator, Chi-Chang Huang, National Taiwan Sport University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909475
- Sponsor's protocol ID
- 22-022
- Status last verified
- Jun 2023
- First submitted
- 1 Jun 2023
- Last updated
- 18 Jun 2023
- 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 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementation With GKEX Sports Probiotic Combo for Muscle Gain and Fat Loss Assessment
- ClinicalTrials.gov ID
- NCT05909475
- Acronym / sponsor ID
- 22-022
- Conditions
- Sport Nutrition, Probiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- National Taiwan Sport UniversityUniversity, hospital or other
- Collaborators
- Grape King Bio Ltd.
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- 24 Dec 2022 (actual)
- Study completion
- 24 Dec 2022 (actual)
- First posted
- 18 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.
Objective: To discuss the "GKEX Sports Probiotics Combination (hereinafter referred to as GKEX)", a product commissioned by Grape King Biotechnology Co., Ltd., and its effects on increasing muscle mass, muscle strength, physical performance and improving body composition when combined with resistance exercise training. Method: The experiment adopts a double-blind design. After screening, 52 subjects (20 males and 32 females) were randomly divided into two groups, each with 10 males and 16 females: (1) placebo without GKEX probiotics Capsule group (Placebo) (2 capsules/day), (2) GKEX group (GKEX) (1x1010 CFU/capsule, 2 capsules/day). All subjects received daily supplementation samples for 6 weeks and received resistance exercise training three times a week. Before the intervention and 6 weeks after the intervention, the diet evaluation, systemic and resistive body composition, muscle ultrasound, muscle strength, maximum oxygen uptake, explosive power, anaerobic power, etc. were detected respectively.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboThe placebo capsule contains microcrystalline cellulose, 2 caps daily use. |
| GKEX | Experimental | Dietary Supplement: GKEXGKEX group. Probiotic capsules contain 10 billion CFU (colony forming units) of GKEX, , 2 caps daily use. |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The tissues and organs of the body are functioning normally
- no disease, fatigue, or weakness
- independent and flexible activities
Key exclusion criteria (8 listed)
- With a history of cardiovascular disease, hypertension, metabolic disease, asthma or cancer diagnosed by a physician
- BMI≧27
- Who have taken anti-inflammatory analgesics or acute and chronic diseases within one month, etc.,
- The students and related stakeholders guided by the host of this plan
- Who have the habit of smoking and drinking
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 |
|---|---|---|
| GKEXGKEX group. Probiotic capsules contain 10 billion CFU (colony forming units) of GKEX, , 2 caps daily use. | Dietary supplement | GKEX |
| PlaceboThe placebo capsule contains microcrystalline cellulose, 2 caps daily use. | Other | Placebo |
Primary outcome
Isometric Mid-Thigh Pull (IMTP_RFD
Time frame: up to 6 weeks
Customized IMTP test equipment and two force plates (type 9287BA, Kistler Instruments AG, Winterthur, Switzerland) were used. All participants stood with their feet the same width apart, and the rod was placed between the thighs, with the torso upright, the spine neutral, and the knee and hip angles at 140°, to familiarize the participants with the IMPT test method. The average absolute peak rate of force development (RFD) parameters were recorded.
Isometric Mid-Thigh Pull (IMTP)_relative peak force
Time frame: up to 6 weeks
Customized IMTP test equipment and two force plates (type 9287BA, Kistler Instruments AG, Winterthur, Switzerland) were used. All participants stood with their feet the same width apart, and the rod was placed between the thighs, with the torso upright, the spine neutral, and the knee and hip angles at 140°, to familiarize the participants with the IMPT test method. The average absolute peak rate of force development (RFD) parameters were recorded.
Wingate Anaerobic Test (WAnT)_relative peak power
Time frame: up to 6 weeks
After a standard warm-up, all subjects were assessed with the classical WAnT on a cycloergometer (Monark 894E, Varberg, Sweden) in a 30 s "go all out" ultramax test. The seat height was adjusted to the satisfaction of each participant, and toe clips prevented the feet from slipping off the pedals. Before the initial test, the subjects warmed up for 5 min, and the power was approximately 50 W. After the warm-up, two preparation exercises lasting 3 s, during which the actual test load was 3% of their own body weight, were applied to accustom the participant to resistance. The test started, and the resistance was set on the friction belt of the dynamometer. External loading was estimated individually at 5% body weight. The average relative peak power parameters were recorded.
Wingate Anaerobic Test (WAnT)_relative mean power
Time frame: up to 6 weeks
After a standard warm-up, all subjects were assessed with the classical WAnT on a cycloergometer (Monark 894E, Varberg, Sweden) in a 30 s "go all out" ultramax test. The seat height was adjusted to the satisfaction of each participant, and toe clips prevented the feet from slipping off the pedals. Before the initial test, the subjects warmed up for 5 min, and the power was approximately 50 W. After the warm-up, two preparation exercises lasting 3 s, during which the actual test load was 3% of their own body weight, were applied to accustom the participant to resistance. The test started, and the resistance was set on the friction belt of the dynamometer. External loading was estimated individually at 5% body weight. The average relative mean power parameters were recorded.
Wingate Anaerobic Test (WAnT)_fatigue index
Time frame: up to 6 weeks
After a standard warm-up, all subjects were assessed with the classical WAnT on a cycloergometer (Monark 894E, Varberg, Sweden) in a 30 s "go all out" ultramax test. The seat height was adjusted to the satisfaction of each participant, and toe clips prevented the feet from slipping off the pedals. Before the initial test, the subjects warmed up for 5 min, and the power was approximately 50 W. After the warm-up, two preparation exercises lasting 3 s, during which the actual test load was 3% of their own body weight, were applied to accustom the participant to resistance. The test started, and the resistance was set on the friction belt of the dynamometer. External loading was estimated individually at 5% body weight. The average fatigue index parameters were recorded.
The Countermovement Jump (CMJ) Test
Time frame: up to 6 weeks
The CMJ test is a practical, effective, reliable, and simple method of measuring lower limb strength, which is related to the maximum speed, strength and explosive force of the lower limbs. For this test, participants stood on the Kistler force measurement platform (9260AA, Kistler Co., Ltd., Switzerland) on both feet and performed to inspection. During the test, they were asked to put their hands on their hips and remain on the platform. After that, they were asked to squat down until the knees bent 90 degrees and then to immediately jump as high as possible. The average power (MF), were recorded during the jump. Each participant repeated the test 3 times, and CMJ data were obtained at the designated points. The instrument was calibrated for each individual's weight.
VO2max
Time frame: up to 6 weeks
To evaluate the maximum oxygen consumption and exercise performance, we used a treadmill (Pulsar, h/p/cosmos, Nussdorf-Traunstein, Germany) and an automatic breathing analyzer (Vmax 29c, Sensor Medics, Yorba Linda, CA, USA). In addition, a polar heart rate device was used to monitor the heart rate (HR). The speed range of the treadmill was set to 7.2 km/h and increased by 1.8 km/h every 2 min until fatigue, according to Bruce's protocol. When the breathing exchange rate (the volume ratio of carbon dioxide produced to oxygen consumed, VCO2/VO2) was higher than 1.10 and reached the maximum heart rate (maximum heart rate = 220 - age), oxygen consumption was considered to be maximum. The three highest VO2max peak were averaged to obtain the VO2max values of the individual volunteers.
Muscle composition_muscle thickness
Time frame: up to 6 weeks
Use muscular ultrasound (BenQ T3300) to scan muscle thickness
Muscle composition_fascia thickness
Time frame: up to 6 weeks
Use muscular ultrasound (BenQ T3300) to scan fascia thickness
dual-energy X-ray absorptiometry, DXA
Time frame: up to 6 weeks
A non-invasive dual-energy X-ray absorptive bone density testing room (Lunar iDXA, GE Healthcare, Chicago, IL, USA) was used for systemic body composition and bone density measurements. The subject was required to lie flat on the test bed, with their body at the center line, and their limbs within the detection range. Two different energy X-rays were used to scan the inspected part, then the scintillation detector received the X-rays that had penetrated the inspected part, and analyzed the obtained muscle mass
Body composition_body fat
Time frame: up to 6 weeks
The multi-frequency principle was applied to measure body composition by using a bioelectrical impedance analyzer (BIA) on an InBody 570 device (In-body, Seoul, South Korea). To perform the measurements, after the subjects' palms and soles were removed from the sensors, the subjects stood on the footing electrodes and held the sensing handles with two hands. During the measurements, the subjects kept their arms open and left their bodies at an angle of 30° without speaking or moving. The subjects also fasted for at least 8 h before the test. The body fat were meansure
Body composition_muscle mass
Time frame: up to 6 weeks
The multi-frequency principle was applied to measure body composition by using a bioelectrical impedance analyzer (BIA) on an InBody 570 device (In-body, Seoul, South Korea). To perform the measurements, after the subjects' palms and soles were removed from the sensors, the subjects stood on the footing electrodes and held the sensing handles with two hands. During the measurements, the subjects kept their arms open and left their bodies at an angle of 30° without speaking or moving. The subjects also fasted for at least 8 h before the test. The muscle mass were meansure
Grip strength
Time frame: up to 6 weeks
Use the armed grip machine (T.K.K.5401, Takei Scientific Instruments Co.,Ltd, Niigata, Japan) to measure, hold each of the left and right hands three times until they are weak, and record the maximum value
10 secondary outcomes
Safety assessment - AST
Time frame: up to 6 weeks
Safety assessment - ALT
Time frame: up to 6 weeks
Safety assessment - T-Cholesterol
Time frame: up to 6 weeks
Safety assessment - Uric Acid
Time frame: up to 6 weeks
Safety assessment - BUN
Time frame: up to 6 weeks
Safety assessment - Creatinine
Time frame: up to 6 weeks
Safety assessment - Glucose
Time frame: up to 6 weeks
Safety assessment - Triglycerides
Time frame: up to 6 weeks
Safety assessment - LDL
Time frame: up to 6 weeks
Safety assessment - HDL
Time frame: up to 6 weeks
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 18 Jun 2023.
- 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.
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 GKEX in people with Sport Nutrition and Probiotic, run by National Taiwan Sport 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 8 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 18 Jun 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?
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?
Isometric Mid-Thigh Pull (IMTP_RFD (time frame: up to 6 weeks). The study lists 13 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 18 Jun 2023.