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Completed

NCT Number: NCT05346432

Effects of Lactobacillus Paracasei PS23 on Anti-fatigue

This research is to explore the effects of supplementing Lactobacillus paracasei PS23 to reduce fatigue and improve physical fitness after exhaustive exercise.

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Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan Sport University

Taoyuan, 333, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PS23

Dietary Supplement

PS23 belongs to Lactobacillus paracasei group.Probiotic capsules contain 10 billion CFU (colony forming units) of PS23

Primary outcomes

  1. 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

  2. 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).

  3. 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

  4. 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)

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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.

  7. 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).

  8. 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).

  9. 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).

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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)

  16. Safety assessment - HDL

    Time frame: From Baseline to 6 Weeks Assessed

    Safety is assessed function of liver and kidney such as HDL (>40mg/dl)

Sponsors and collaborators

Lead sponsor

Chi-Chang Huang

Other

Collaborators

  • Bened Biomedical Co., Ltd.

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 26, 2022
Registry last updated
Jul 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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