Effects of Lactobacillus Paracasei PS23 on Anti-fatigue

NCT05346432 | Completed

• 1 other identifier: 22-003-A2
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fatigue

Outcome Measures

Primary Outcomes (13)

• 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

  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).

  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

  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)

  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

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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

  From Baseline to 6 Weeks Assessed

• Change in Perceived Stress Scale (PSS) Score From Baseline to Change in Perceived Stress Scale (PSS)

  From Baseline to 6 Weeks Assessed

• Differences in the The Profile of Mood States (POMS) before and after probiotics consumption

  From Baseline to 6 Weeks Assessed

• The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16

  From Baseline to 6 Weeks Assessed

• Visual Analogue Scale-GI (VAS-GI)

  From Baseline to 6 Weeks Assessed

Study Arms (3)

PS23

EXPERIMENTAL

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

Dietary Supplement: PS23

heat-treated PS23

EXPERIMENTAL

PS23 heat-treated, 2 caps daily use.

Dietary Supplement: PS23

placebo

PLACEBO COMPARATOR

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

Dietary Supplement: PS23

Interventions

PS23 DIETARY_SUPPLEMENT

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

PS23; heat-treated PS23; placebo

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chi-Chang Huang: lead
• Bened Biomedical Co., Ltd.: collaborator

Study Sites (1)

National Taiwan Sport University

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chi-Chang Huang, Ph.D

  National Taiwan Sport University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 26, 2022
• Study Start: May 1, 2022
• Primary Completion: July 10, 2022
• Study Completion: July 10, 2022
• Last Updated: July 12, 2022

Record last verified: 2022-07

Locations

TW (1)