FatigueNCT05346432
Effects of Lactobacillus Paracasei PS23 on Anti-fatigue
A study testing PS23 in people with Fatigue, run by Chi-Chang Huang at 1 site in Taiwan.
Trial summary
This research is to explore the effects of supplementing Lactobacillus paracasei PS23 to reduce fatigue and improve physical fitness after exhaustive exercise. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- What is being tested?
- PS23
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2022to 10 Jul 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult men and women aged 20-40 who are generally non-athletic players
Who cannot join
- BMI≧27
- Known allergy to probiotics
- Have current or history of inflammatory bowel disease
- Patients using of other probiotic products (sachet, capsule or tablet) within the preceding two weeks
- Those who have taken medication such as anti-inflammatory pain killer or antibiotics in the past one month
- smoker and alcoholic
Show all 10Show fewer
- Who have been injured within 6 months
- Who has been diagnosed and treated of cardiovascular disease, hypertension, metabolic disease, asthma, or cancer
- Have undergone surgery of liver, bladder, or gastrointestinal tract
- Who has conflict of interest with PI
Trial locations and contacts
1 site in 1 country.
About this study
This research is to explore the effects of supplementing Lactobacillus paracasei PS23 to reduce fatigue and improve physical fitness after exhaustive exercise.
Read the detailed description
Studies have found that the intestinal flora of athletes is different from that of ordinary people, and short-chain fatty acids play a very important role. Previous animal experiments have found that supplementing with specific probiotics can slow down muscle loss in aging mice. In addition, clinical studies have found that supplementing with probiotics can improve sports performance by regulating the intestinal flora and related metabolites. Therefore, the purpose of this research is to explore the effects of supplementing Lactobacillus paracasei PS23 to reduce fatigue and improve physical fitness after exhaustive exercise. This study compares supplementary samples with placebo and adopts a double-blind study design.
- Conditions
- Fatigue
- Being tested
- PS23
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PS23Dietary supplement
PS23 belongs to Lactobacillus paracasei group.Probiotic capsules contain 10 billion CFU (colony forming units) of PS23
| Study group | Role | What they receive |
|---|---|---|
| PS23 | Experimental | The PS23 belongs to Lactobacillus paracasei group, 2 caps daily use. Receives: Dietary Supplement: PS23 |
| heat-treated PS23 | Experimental | PS23 heat-treated, 2 caps daily use. Receives: Dietary Supplement: PS23 |
| placebo | Placebo comparator | The placebo capsule contains microcrystalline cellulose, 2 caps daily use. Receives: Dietary Supplement: PS23 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress assessment - difference of Testosterone level
To assess inflammation indicators, volunteers fasted for at least 8 hours before performing muscle exhaustion exercises. At designated time points in the recovery period, including baseline (0) and 3h, 24h, and 48 after exercise, blood samples were collected with brachial venous catheters. Used commercial kit human Testosterone (Cayman, Mich, USA) and Elisa reader (PerkinElmer, Massachusetts, USA) for analysis Male 265-923 (in ng/dl) Female 15-70 (in ng/dl) for 19 years and older
Measured: From Baseline to 6 Weeks Assessed
Difference in Clinical Biochemistry of CK level
To assess inflammation indicators, volunteers fasted for at least 8 hours before performing muscle exhaustion exercises. At designated time points in the recovery period, blood samples were collected with brachial venous catheters. Assess serum CK(Creatine Kinase, U/L) to monitor physiological fitness. Serum CK (U/L), were assessed for monitoring physiological adaptation. All biochemical indices were assessed using an autoanalyzer (Hitachi 7060, Tokyo, Japan).
Measured: From Baseline to 6 Weeks Assessed, including baseline (0) and 3h, 24h, and 48 after exercise
Difference of Muscle damage - blood level of myoglobin
To assess Muscle damage such as myoglobin (Female:14.3~65.8, Male:17.4~105.7) Volunteers fasted for at least 8 hours before performing muscle exhaustion exercises. At designated time points in the recovery period, blood samples were collected with brachial venous catheters. Used commercial kit human myoglobin (Cayman, Mich, USA) and Elisa reader (PerkinElmer, Massachusetts, USA) for analysis
Measured: From Baseline to 6 Weeks Assessed, including baseline (0) and 3h, 24h, and 48 after exercise
Oxidative stress assessment - blood of MDA level
comparing blood levels of oxidative markers such as Malondialdehyde (MDA)
Measured: From Baseline to 6 Weeks Assessed
Difference in Oxidative stress - blood level of CRP
To assess inflammation indicators, volunteers fasted for at least 8 hours before performing muscle exhaustion exercises. At designated time points in the recovery period, blood samples were collected with brachial venous catheters. Used commercial kit human CRP (Cayman, Mich, USA) and Elisa reader (PerkinElmer, Massachusetts, USA) for analysis
Measured: From Baseline to 6 Weeks Assessed, including baseline (0) and 3h, 24h, and 48 after exercise
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: From Baseline to 6 Weeks Assessed, In this study, this assessment was performed before and 24 and 48h after the exhaustive exercise program.
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 peak power (Fpeak), 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: From Baseline to 6 Weeks Assessed, In this study, this assessment was performed before and 24 and 48h after the exhaustive exercise program.
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. flight time (FT) 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: From Baseline to 6 Weeks Assessed, In this study, this assessment was performed before and 24 and 48h after the exhaustive exercise program.
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 strength development speed (30 ms) 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: From Baseline to 6 Weeks Assessed, In this study, this assessment was performed before and 24 and 48h after the exhaustive exercise program.
Wingate Anaerobic Test (WAnT)
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 recorded results were the relative mean power (W/kg), relative peak power (W/kg), and fatigue index (%). This assessment was performed before and 24 and 72 h after the exhaustive exercise program.
Measured: From Baseline to 6 Weeks Assessed
Isometric Mid-Thigh Pull (IMTP)
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 force (PF), relative peak force (N/Kg), rate of force development (RFD), peak rate of force development (pRFD), time to peak force (TPF) and time to peak rate of force development (TPRFD) parameters were recorded. This assessment was performed before and 24 and 48h after the exhaustive exercise program.
Measured: From Baseline to 6 Weeks Assessed
Isometric Mid-Thigh Pull (IMTP)
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 force (PF) were recorded.
Measured: From Baseline to 6 Weeks Assessed. This assessment was performed before and 24 and 48h after the exhaustive exercise program.
Isometric Mid-Thigh Pull (IMTP)
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: From Baseline to 6 Weeks Assessed. This assessment was performed before and 24 and 48h after the exhaustive exercise program.
Secondary outcomes (16)
Gut microbiota
Collect the DNA of fecal flora to test the diversity and abundance of gut microbiota in Stool samples before and after probiotics
Measured: From Baseline to 6 Weeks Assessed
Change in Perceived Stress Scale (PSS) Score From Baseline to Change in Perceived Stress Scale (PSS)
The PSS scores is a rating tool used to gauge the course of stree. The minimum total score possible is 0 and the maximum total score possible is 40. Higher values represent a worse outcome.
Measured: From Baseline to 6 Weeks Assessed
Differences in the The Profile of Mood States (POMS) before and after probiotics consumption
The Profile of Mood States (POMS) is a psychological rating scale used to assess transient, distinct mood states. The Chinese version POMS measures six different dimensions of mood swings over a period of time. These include: Tension or Anxiety, Anger or Hostility, Vigor or Activity, Fatigue or Inertia, Depression or Dejection, Confusion or Bewilderment. A four-point scale ranging from "not at all" to "extremely" is administered by experimenters to patients to assess their mood states.
Measured: From Baseline to 6 Weeks Assessed
The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16
The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16 (QLESQ-16) is a valid, reliable self-report instrument for assessing quality of life.
Measured: From Baseline to 6 Weeks Assessed
Visual Analogue Scale-GI (VAS-GI)
Visual Analogue Scale (VAS) consists of a line, 10 cm in length. Individuals point to or mark a spot on the line where they feel indicates their current their emotion, fatigue level and sleep quality. The score of emotion level is from 0cm (very nervous) to 10 cm (very relaxing). The score of fatigue level is from 0 cm (very energetic) to 10 cm (very sleepy). The score of sleep quality is from 0 cm (poor) to 10 cm (sleep well). The maximum total score is 100% (equal 10cm).
Measured: From Baseline to 6 Weeks Assessed
Change in Patient Global Impression of Change (PGIC)
The PGIC consists of one item taken from the clinical global impression and adapted to the patient. The minimum total score possible is 1 and the maximum total score possible is 7. Higher values represent a worse outcome.
Measured: From Baseline to 6 Weeks Assessed
Safety assessment - AST
Safety is assessed function of liver and kidney such as AST (8-38 IU/L).
Measured: From Baseline to 6 Weeks Assessed
Safety assessment - ALT
Safety is assessed function of liver and kidney such as ALT (4-44 IU/L).
Measured: From Baseline to 6 Weeks Assessed
Safety assessment - T-Cholesterol
Safety is assessed function of liver and kidney such as T-Cholesterol (<170 mg/dL).
Measured: From Baseline to 6 Weeks Assessed
Safety assessment - Uric Acid
Safety is assessed function of liver and kidney such as Uric Acid (3.4-7.6 mg/dl)
Measured: From Baseline to 6 Weeks Assessed
Safety assessment - Bun
Safety is assessed function of liver and kidney such as Bun (6-20 mg/dl)
Measured: From Baseline to 6 Weeks Assessed
Safety assessment - Creatinine
Safety is assessed function of liver and kidney such as Creatinine (0.6-1.3 mg/dl)
Measured: From Baseline to 6 Weeks Assessed
Safety assessment - Glucose
Safety is assessed function of liver and kidney such as Glucose (70~100 mg/dL)
Measured: From one week before Baseline to 6 Weeks Assessed
Safety assessment - Triglycerides
Safety is assessed function of liver and kidney such as Triglycerides (<150 mg/dL)
Measured: From Baseline to 6 Weeks Assessed
Safety assessment - LDL
Safety is assessed function of liver and kidney such as LDL (0~140mg/dl)
Measured: From Baseline to 6 Weeks Assessed
Safety assessment - HDL
Safety is assessed function of liver and kidney such as HDL (>40mg/dl)
Measured: From Baseline to 6 Weeks Assessed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start1 May 2022
- Primary completion10 Jul 2022
- Study completion10 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies 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, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chi-Chang Huang
- Sponsor type
- University, hospital or other
- Collaborators
- Bened Biomedical Co., Ltd.
- Responsible party
- Sponsor-investigator, Chi-Chang Huang, National Taiwan Sport University
- Investigators
- Chi-Chang Huang, Ph.D, Principal investigator, National Taiwan Sport University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346432
- Sponsor's protocol ID
- 22-003-A2
- Status last verified
- Jul 2022
- First submitted
- 24 Mar 2022
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lactobacillus Paracasei PS23 on Anti-fatigue
- ClinicalTrials.gov ID
- NCT05346432
- Acronym / sponsor ID
- 22-003-A2
- Conditions
- Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Chi-Chang HuangUniversity, hospital or other
- Collaborators
- Bened Biomedical Co., Ltd.
- Study start
- 1 May 2022 (actual)
- Primary completion
- 10 Jul 2022 (actual)
- Study completion
- 10 Jul 2022 (actual)
- First posted
- 26 Apr 2022 (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.
This research is to explore the effects of supplementing Lactobacillus paracasei PS23 to reduce fatigue and improve physical fitness after exhaustive exercise.
Detailed description
Studies have found that the intestinal flora of athletes is different from that of ordinary people, and short-chain fatty acids play a very important role. Previous animal experiments have found that supplementing with specific probiotics can slow down muscle loss in aging mice. In addition, clinical studies have found that supplementing with probiotics can improve sports performance by regulating the intestinal flora and related metabolites. Therefore, the purpose of this research is to explore the effects of supplementing Lactobacillus paracasei PS23 to reduce fatigue and improve physical fitness after exhaustive exercise. This study compares supplementary samples with placebo and adopts a double-blind study design.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PS23 | Experimental | Dietary Supplement: PS23The PS23 belongs to Lactobacillus paracasei group, 2 caps daily use. |
| heat-treated PS23 | Experimental | Dietary Supplement: PS23PS23 heat-treated, 2 caps daily use. |
| placebo | Placebo comparator | Dietary Supplement: PS23The placebo capsule contains microcrystalline cellulose, 2 caps daily use. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy adult men and women aged 20-40 who are generally non-athletic players
Key exclusion criteria (10 listed)
- BMI≧27
- Known allergy to probiotics
- Have current or history of inflammatory bowel disease
- Patients using of other probiotic products (sachet, capsule or tablet) within the preceding two weeks
- Those who have taken medication such as anti-inflammatory pain killer or antibiotics in the past one month
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 |
|---|---|---|
| PS23PS23 belongs to Lactobacillus paracasei group.Probiotic capsules contain 10 billion CFU (colony forming units) of PS23 | Dietary supplement | PS23, heat-treated PS23, placebo |
Primary outcome
Stress assessment - difference of Testosterone level
Time frame: From Baseline to 6 Weeks Assessed
To assess inflammation indicators, volunteers fasted for at least 8 hours before performing muscle exhaustion exercises. At designated time points in the recovery period, including baseline (0) and 3h, 24h, and 48 after exercise, blood samples were collected with brachial venous catheters. Used commercial kit human Testosterone (Cayman, Mich, USA) and Elisa reader (PerkinElmer, Massachusetts, USA) for analysis Male 265-923 (in ng/dl) Female 15-70 (in ng/dl) for 19 years and older
Difference in Clinical Biochemistry of CK level
Time frame: From Baseline to 6 Weeks Assessed, including baseline (0) and 3h, 24h, and 48 after exercise
To assess inflammation indicators, volunteers fasted for at least 8 hours before performing muscle exhaustion exercises. At designated time points in the recovery period, blood samples were collected with brachial venous catheters. Assess serum CK(Creatine Kinase, U/L) to monitor physiological fitness. Serum CK (U/L), were assessed for monitoring physiological adaptation. All biochemical indices were assessed using an autoanalyzer (Hitachi 7060, Tokyo, Japan).
Difference of Muscle damage - blood level of myoglobin
Time frame: From Baseline to 6 Weeks Assessed, including baseline (0) and 3h, 24h, and 48 after exercise
To assess Muscle damage such as myoglobin (Female:14.3~65.8, Male:17.4~105.7) Volunteers fasted for at least 8 hours before performing muscle exhaustion exercises. At designated time points in the recovery period, blood samples were collected with brachial venous catheters. Used commercial kit human myoglobin (Cayman, Mich, USA) and Elisa reader (PerkinElmer, Massachusetts, USA) for analysis
Oxidative stress assessment - blood of MDA level
Time frame: From Baseline to 6 Weeks Assessed
comparing blood levels of oxidative markers such as Malondialdehyde (MDA)
Difference in Oxidative stress - blood level of CRP
Time frame: From Baseline to 6 Weeks Assessed, including baseline (0) and 3h, 24h, and 48 after exercise
To assess inflammation indicators, volunteers fasted for at least 8 hours before performing muscle exhaustion exercises. At designated time points in the recovery period, blood samples were collected with brachial venous catheters. Used commercial kit human CRP (Cayman, Mich, USA) and Elisa reader (PerkinElmer, Massachusetts, USA) for analysis
The Countermovement Jump (CMJ) Test
Time frame: From Baseline to 6 Weeks Assessed, In this study, this assessment was performed before and 24 and 48h after the exhaustive exercise program.
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.
The Countermovement Jump (CMJ) Test
Time frame: From Baseline to 6 Weeks Assessed, In this study, this assessment was performed before and 24 and 48h after the exhaustive exercise program.
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 peak power (Fpeak), 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.
The Countermovement Jump (CMJ) Test
Time frame: From Baseline to 6 Weeks Assessed, In this study, this assessment was performed before and 24 and 48h after the exhaustive exercise program.
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. flight time (FT) 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.
The Countermovement Jump (CMJ) Test
Time frame: From Baseline to 6 Weeks Assessed, In this study, this assessment was performed before and 24 and 48h after the exhaustive exercise program.
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 strength development speed (30 ms) 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.
Wingate Anaerobic Test (WAnT)
Time frame: From Baseline to 6 Weeks Assessed
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 recorded results were the relative mean power (W/kg), relative peak power (W/kg), and fatigue index (%). This assessment was performed before and 24 and 72 h after the exhaustive exercise program.
Isometric Mid-Thigh Pull (IMTP)
Time frame: From Baseline to 6 Weeks Assessed
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 force (PF), relative peak force (N/Kg), rate of force development (RFD), peak rate of force development (pRFD), time to peak force (TPF) and time to peak rate of force development (TPRFD) parameters were recorded. This assessment was performed before and 24 and 48h after the exhaustive exercise program.
Isometric Mid-Thigh Pull (IMTP)
Time frame: From Baseline to 6 Weeks Assessed. This assessment was performed before and 24 and 48h after the exhaustive exercise program.
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 force (PF) were recorded.
Isometric Mid-Thigh Pull (IMTP)
Time frame: From Baseline to 6 Weeks Assessed. This assessment was performed before and 24 and 48h after the exhaustive exercise program.
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.
16 secondary outcomes
Gut microbiota
Time frame: From Baseline to 6 Weeks Assessed
Change in Perceived Stress Scale (PSS) Score From Baseline to Change in Perceived Stress Scale (PSS)
Time frame: From Baseline to 6 Weeks Assessed
Differences in the The Profile of Mood States (POMS) before and after probiotics consumption
Time frame: From Baseline to 6 Weeks Assessed
The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16
Time frame: From Baseline to 6 Weeks Assessed
Visual Analogue Scale-GI (VAS-GI)
Time frame: From Baseline to 6 Weeks Assessed
Change in Patient Global Impression of Change (PGIC)
Time frame: From Baseline to 6 Weeks Assessed
Safety assessment - AST
Time frame: From Baseline to 6 Weeks Assessed
Safety assessment - ALT
Time frame: From Baseline to 6 Weeks Assessed
Safety assessment - T-Cholesterol
Time frame: From Baseline to 6 Weeks Assessed
Safety assessment - Uric Acid
Time frame: From Baseline to 6 Weeks Assessed
Safety assessment - Bun
Time frame: From Baseline to 6 Weeks Assessed
Safety assessment - Creatinine
Time frame: From Baseline to 6 Weeks Assessed
Safety assessment - Glucose
Time frame: From one week before Baseline to 6 Weeks Assessed
Safety assessment - Triglycerides
Time frame: From Baseline to 6 Weeks Assessed
Safety assessment - LDL
Time frame: From Baseline to 6 Weeks Assessed
Safety assessment - HDL
Time frame: From Baseline to 6 Weeks Assessed
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 12 Jul 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Fatigue
Enrolling by invitation
Dance-Based Exercise for Cancer-Related Fatigue in Breast Cancer Patients
Breast Neoplasms
Not yet recruiting
Mind Body Reprogramming Therapy for Adolescents With Chronic Fatigue
Chronic Fatigue
Not yet recruiting
Comparison of Functional Inspiratory Muscle Training and Combined Exercise Training in Individuals With Type 2 Diabetes
Type 2 Diabetes Mellitus
Recruiting
Acute Effects of Post-Exercise Hyperoxia on Recovery in Cycling
Athletic Performance, Hyperbaric Oxygenation
Recruiting
Recovery After Fatigue in Young Athletes: Comparison Between TECAR Therapy and Cycle Ergometer"
Muscle Fatigue, Healthy Adult
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.
Chi-Chang Huang, Ph.D principal investigator
National Taiwan Sport University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PS23 in people with Fatigue, run by Chi-Chang Huang 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 1 inclusion and 10 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 12 Jul 2022. 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?
Stress assessment - difference of Testosterone level (time frame: From Baseline to 6 Weeks Assessed). 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 12 Jul 2022.