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Effects of Lactobacillus Paracasei PS23 on Anti-fatigue

Primary Purpose

Fatigue

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
PS23
Sponsored by
Chi-Chang Huang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Fatigue

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy adult men and women aged 20-40 who are generally non-athletic players

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • National Taiwan Sport University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

PS23

heat-treated PS23

placebo

Arm Description

The PS23 belongs to Lactobacillus paracasei group, 2 caps daily use.

PS23 heat-treated, 2 caps daily use.

The placebo capsule contains microcrystalline cellulose, 2 caps daily use.

Outcomes

Primary Outcome Measures

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
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).
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
Oxidative stress assessment - blood of MDA level
comparing blood levels of oxidative markers such as Malondialdehyde (MDA)
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
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Gut microbiota
Collect the DNA of fecal flora to test the diversity and abundance of gut microbiota in Stool samples before and after probiotics
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.
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.
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.
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).
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.
Safety assessment - AST
Safety is assessed function of liver and kidney such as AST (8-38 IU/L).
Safety assessment - ALT
Safety is assessed function of liver and kidney such as ALT (4-44 IU/L).
Safety assessment - T-Cholesterol
Safety is assessed function of liver and kidney such as T-Cholesterol (<170 mg/dL).
Safety assessment - Uric Acid
Safety is assessed function of liver and kidney such as Uric Acid (3.4-7.6 mg/dl)
Safety assessment - Bun
Safety is assessed function of liver and kidney such as Bun (6-20 mg/dl)
Safety assessment - Creatinine
Safety is assessed function of liver and kidney such as Creatinine (0.6-1.3 mg/dl)
Safety assessment - Glucose
Safety is assessed function of liver and kidney such as Glucose (70~100 mg/dL)
Safety assessment - Triglycerides
Safety is assessed function of liver and kidney such as Triglycerides (<150 mg/dL)
Safety assessment - LDL
Safety is assessed function of liver and kidney such as LDL (0~140mg/dl)
Safety assessment - HDL
Safety is assessed function of liver and kidney such as HDL (>40mg/dl)

Full Information

First Posted
March 24, 2022
Last Updated
July 10, 2022
Sponsor
Chi-Chang Huang
Collaborators
Bened Biomedical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05346432
Brief Title
Effects of Lactobacillus Paracasei PS23 on Anti-fatigue
Official Title
Effects of Lactobacillus Paracasei PS23 on Anti-fatigue
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
July 10, 2022 (Actual)
Study Completion Date
July 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chi-Chang Huang
Collaborators
Bened Biomedical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PS23
Arm Type
Experimental
Arm Description
The PS23 belongs to Lactobacillus paracasei group, 2 caps daily use.
Arm Title
heat-treated PS23
Arm Type
Experimental
Arm Description
PS23 heat-treated, 2 caps daily use.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
The placebo capsule contains microcrystalline cellulose, 2 caps daily use.
Intervention Type
Dietary Supplement
Intervention Name(s)
PS23
Intervention Description
PS23 belongs to Lactobacillus paracasei group.Probiotic capsules contain 10 billion CFU (colony forming units) of PS23
Primary Outcome Measure Information:
Title
Stress assessment - difference of Testosterone level
Description
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
Time Frame
From Baseline to 6 Weeks Assessed
Title
Difference in Clinical Biochemistry of CK level
Description
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).
Time Frame
From Baseline to 6 Weeks Assessed, including baseline (0) and 3h, 24h, and 48 after exercise
Title
Difference of Muscle damage - blood level of myoglobin
Description
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
Time Frame
From Baseline to 6 Weeks Assessed, including baseline (0) and 3h, 24h, and 48 after exercise
Title
Oxidative stress assessment - blood of MDA level
Description
comparing blood levels of oxidative markers such as Malondialdehyde (MDA)
Time Frame
From Baseline to 6 Weeks Assessed
Title
Difference in Oxidative stress - blood level of CRP
Description
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
Time Frame
From Baseline to 6 Weeks Assessed, including baseline (0) and 3h, 24h, and 48 after exercise
Title
The Countermovement Jump (CMJ) Test
Description
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.
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.
Title
The Countermovement Jump (CMJ) Test
Description
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.
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.
Title
The Countermovement Jump (CMJ) Test
Description
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.
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.
Title
The Countermovement Jump (CMJ) Test
Description
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.
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.
Title
Wingate Anaerobic Test (WAnT)
Description
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.
Time Frame
From Baseline to 6 Weeks Assessed
Title
Isometric Mid-Thigh Pull (IMTP)
Description
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.
Time Frame
From Baseline to 6 Weeks Assessed
Title
Isometric Mid-Thigh Pull (IMTP)
Description
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.
Time Frame
From Baseline to 6 Weeks Assessed. This assessment was performed before and 24 and 48h after the exhaustive exercise program.
Title
Isometric Mid-Thigh Pull (IMTP)
Description
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.
Time Frame
From Baseline to 6 Weeks Assessed. This assessment was performed before and 24 and 48h after the exhaustive exercise program.
Secondary Outcome Measure Information:
Title
Gut microbiota
Description
Collect the DNA of fecal flora to test the diversity and abundance of gut microbiota in Stool samples before and after probiotics
Time Frame
From Baseline to 6 Weeks Assessed
Title
Change in Perceived Stress Scale (PSS) Score From Baseline to Change in Perceived Stress Scale (PSS)
Description
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.
Time Frame
From Baseline to 6 Weeks Assessed
Title
Differences in the The Profile of Mood States (POMS) before and after probiotics consumption
Description
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.
Time Frame
From Baseline to 6 Weeks Assessed
Title
The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16
Description
The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16 (QLESQ-16) is a valid, reliable self-report instrument for assessing quality of life.
Time Frame
From Baseline to 6 Weeks Assessed
Title
Visual Analogue Scale-GI (VAS-GI)
Description
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).
Time Frame
From Baseline to 6 Weeks Assessed
Title
Change in Patient Global Impression of Change (PGIC)
Description
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.
Time Frame
From Baseline to 6 Weeks Assessed
Title
Safety assessment - AST
Description
Safety is assessed function of liver and kidney such as AST (8-38 IU/L).
Time Frame
From Baseline to 6 Weeks Assessed
Title
Safety assessment - ALT
Description
Safety is assessed function of liver and kidney such as ALT (4-44 IU/L).
Time Frame
From Baseline to 6 Weeks Assessed
Title
Safety assessment - T-Cholesterol
Description
Safety is assessed function of liver and kidney such as T-Cholesterol (<170 mg/dL).
Time Frame
From Baseline to 6 Weeks Assessed
Title
Safety assessment - Uric Acid
Description
Safety is assessed function of liver and kidney such as Uric Acid (3.4-7.6 mg/dl)
Time Frame
From Baseline to 6 Weeks Assessed
Title
Safety assessment - Bun
Description
Safety is assessed function of liver and kidney such as Bun (6-20 mg/dl)
Time Frame
From Baseline to 6 Weeks Assessed
Title
Safety assessment - Creatinine
Description
Safety is assessed function of liver and kidney such as Creatinine (0.6-1.3 mg/dl)
Time Frame
From Baseline to 6 Weeks Assessed
Title
Safety assessment - Glucose
Description
Safety is assessed function of liver and kidney such as Glucose (70~100 mg/dL)
Time Frame
From one week before Baseline to 6 Weeks Assessed
Title
Safety assessment - Triglycerides
Description
Safety is assessed function of liver and kidney such as Triglycerides (<150 mg/dL)
Time Frame
From Baseline to 6 Weeks Assessed
Title
Safety assessment - LDL
Description
Safety is assessed function of liver and kidney such as LDL (0~140mg/dl)
Time Frame
From Baseline to 6 Weeks Assessed
Title
Safety assessment - HDL
Description
Safety is assessed function of liver and kidney such as HDL (>40mg/dl)
Time Frame
From Baseline to 6 Weeks Assessed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adult men and women aged 20-40 who are generally non-athletic players Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chi-Chang Huang, Ph.D
Organizational Affiliation
National Taiwan Sport University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan Sport University
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effects of Lactobacillus Paracasei PS23 on Anti-fatigue

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