Effects of Lactobacillus Paracasei PS23 on Anti-fatigue

July 10, 2022 updated by: Chi-Chang Huang
This research is to explore the effects of supplementing Lactobacillus paracasei PS23 to reduce fatigue and improve physical fitness after exhaustive exercise.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 333
        • National Taiwan Sport University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PS23
The PS23 belongs to Lactobacillus paracasei group, 2 caps daily use.
Dietary supplement: PS23
PS23 belongs to Lactobacillus paracasei group.Probiotic capsules contain 10 billion CFU (colony forming units) of PS23
Experimental: heat-treated PS23
PS23 heat-treated, 2 caps daily use.
Dietary supplement: PS23
PS23 belongs to Lactobacillus paracasei group.Probiotic capsules contain 10 billion CFU (colony forming units) of PS23
Placebo Comparator: placebo
The placebo capsule contains microcrystalline cellulose, 2 caps daily use.
Dietary supplement: PS23
PS23 belongs to Lactobacillus paracasei group.Probiotic capsules contain 10 billion CFU (colony forming units) of PS23

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From Baseline to 6 Weeks Assessed
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).
From Baseline to 6 Weeks Assessed, including baseline (0) and 3h, 24h, and 48 after exercise
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
From Baseline to 6 Weeks Assessed, including baseline (0) and 3h, 24h, and 48 after exercise
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)
From Baseline to 6 Weeks Assessed
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
From Baseline to 6 Weeks Assessed, including baseline (0) and 3h, 24h, and 48 after exercise
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.
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
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.
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
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.
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
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.
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)
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.
From Baseline to 6 Weeks Assessed
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.
From Baseline to 6 Weeks Assessed
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.
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)
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.
From Baseline to 6 Weeks Assessed. This assessment was performed before and 24 and 48h after the exhaustive exercise program.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gut microbiota
Time Frame: From Baseline to 6 Weeks Assessed
Collect the DNA of fecal flora to test the diversity and abundance of gut microbiota in Stool samples before and after probiotics
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
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.
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 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.
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
The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16 (QLESQ-16) is a valid, reliable self-report instrument for assessing quality of life.
From Baseline to 6 Weeks Assessed
Visual Analogue Scale-GI (VAS-GI)
Time Frame: From Baseline to 6 Weeks Assessed
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).
From Baseline to 6 Weeks Assessed
Change in Patient Global Impression of Change (PGIC)
Time Frame: From Baseline to 6 Weeks Assessed
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.
From Baseline to 6 Weeks Assessed
Safety assessment - AST
Time Frame: From Baseline to 6 Weeks Assessed
Safety is assessed function of liver and kidney such as AST (8-38 IU/L).
From Baseline to 6 Weeks Assessed
Safety assessment - ALT
Time Frame: From Baseline to 6 Weeks Assessed
Safety is assessed function of liver and kidney such as ALT (4-44 IU/L).
From Baseline to 6 Weeks Assessed
Safety assessment - T-Cholesterol
Time Frame: From Baseline to 6 Weeks Assessed
Safety is assessed function of liver and kidney such as T-Cholesterol (<170 mg/dL).
From Baseline to 6 Weeks Assessed
Safety assessment - Uric Acid
Time Frame: From Baseline to 6 Weeks Assessed
Safety is assessed function of liver and kidney such as Uric Acid (3.4-7.6 mg/dl)
From Baseline to 6 Weeks Assessed
Safety assessment - Bun
Time Frame: From Baseline to 6 Weeks Assessed
Safety is assessed function of liver and kidney such as Bun (6-20 mg/dl)
From Baseline to 6 Weeks Assessed
Safety assessment - Creatinine
Time Frame: From Baseline to 6 Weeks Assessed
Safety is assessed function of liver and kidney such as Creatinine (0.6-1.3 mg/dl)
From Baseline to 6 Weeks Assessed
Safety assessment - Glucose
Time Frame: From one week before Baseline to 6 Weeks Assessed
Safety is assessed function of liver and kidney such as Glucose (70~100 mg/dL)
From one week before Baseline to 6 Weeks Assessed
Safety assessment - Triglycerides
Time Frame: From Baseline to 6 Weeks Assessed
Safety is assessed function of liver and kidney such as Triglycerides (<150 mg/dL)
From Baseline to 6 Weeks Assessed
Safety assessment - LDL
Time Frame: From Baseline to 6 Weeks Assessed
Safety is assessed function of liver and kidney such as LDL (0~140mg/dl)
From Baseline to 6 Weeks Assessed
Safety assessment - HDL
Time Frame: From Baseline to 6 Weeks Assessed
Safety is assessed function of liver and kidney such as HDL (>40mg/dl)
From Baseline to 6 Weeks Assessed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chi-Chang Huang

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bened Biomedical Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chi-Chang Huang, Ph.D, National Taiwan Sport University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 10, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 10, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 12, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22-003-A2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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