Clinical trial NCT05346432: Effects of Lactobacillus Paracasei PS23 on Anti-fatigue
Official title: Effects of Lactobacillus Paracasei PS23 on Anti-fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Lead sponsor: National Taiwan Sport University
Sponsor class: OTHER
Collaborators: name: Bened Biomedical Co., Ltd.
First posted: 2022-04-26
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Stress assessment - difference of Testosterone level
timeFrame: From Baseline to 6 Weeks Assessed
measure: Difference in Clinical Biochemistry of CK level
timeFrame: From Baseline to 6 Weeks Assessed, including baseline (0) and 3h, 24h, and 48 after exercise
measure: Difference of Muscle damage - blood level of myoglobin
timeFrame: From Baseline to 6 Weeks Assessed, including baseline (0) and 3h, 24h, and 48 after exercise
measure: Oxidative stress assessment - blood of MDA level
timeFrame: From Baseline to 6 Weeks Assessed
measure: Difference in Oxidative stress - blood level of CRP
timeFrame: From Baseline to 6 Weeks Assessed, including baseline (0) and 3h, 24h, and 48 after exercise
measure: The Countermovement Jump (CMJ) Test
timeFrame: From Baseline to 6 Weeks Assessed, In this study, this assessment was performed before and 24 and 48h after the exhaustive exercise program.
measure: The Countermovement Jump (CMJ) Test
timeFrame: From Baseline to 6 Weeks Assessed, In this study, this assessment was performed before and 24 and 48h after the exhaustive exercise program.
measure: The Countermovement Jump (CMJ) Test
timeFrame: From Baseline to 6 Weeks Assessed, In this study, this assessment was performed before and 24 and 48h after the exhaustive exercise program.
measure: The Countermovement Jump (CMJ) Test
timeFrame: From Baseline to 6 Weeks Assessed, In this study, this assessment was performed before and 24 and 48h after the exhaustive exercise program.
measure: Wingate Anaerobic Test (WAnT)
timeFrame: From Baseline to 6 Weeks Assessed
measure: Isometric Mid-Thigh Pull (IMTP)
timeFrame: From Baseline to 6 Weeks Assessed
measure: Isometric Mid-Thigh Pull (IMTP)
timeFrame: From Baseline to 6 Weeks Assessed. This assessment was performed before and 24 and 48h after the exhaustive exercise program.
measure: Isometric Mid-Thigh Pull (IMTP)
timeFrame: From Baseline to 6 Weeks Assessed. This assessment was performed before and 24 and 48h after the exhaustive exercise program.
Secondary outcomes:
measure: Gut microbiota
timeFrame: From Baseline to 6 Weeks Assessed
measure: Change in Perceived Stress Scale (PSS) Score From Baseline to Change in Perceived Stress Scale (PSS)
timeFrame: From Baseline to 6 Weeks Assessed
measure: Differences in the The Profile of Mood States (POMS) before and after probiotics consumption
timeFrame: From Baseline to 6 Weeks Assessed
measure: The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16
timeFrame: From Baseline to 6 Weeks Assessed
measure: Visual Analogue Scale-GI (VAS-GI)
timeFrame: From Baseline to 6 Weeks Assessed
measure: Change in Patient Global Impression of Change (PGIC)
timeFrame: From Baseline to 6 Weeks Assessed
measure: Safety assessment - AST
timeFrame: From Baseline to 6 Weeks Assessed
measure: Safety assessment - ALT
timeFrame: From Baseline to 6 Weeks Assessed
measure: Safety assessment - T-Cholesterol
timeFrame: From Baseline to 6 Weeks Assessed
measure: Safety assessment - Uric Acid
timeFrame: From Baseline to 6 Weeks Assessed
measure: Safety assessment - Bun
timeFrame: From Baseline to 6 Weeks Assessed
measure: Safety assessment - Creatinine
timeFrame: From Baseline to 6 Weeks Assessed
measure: Safety assessment - Glucose
timeFrame: From one week before Baseline to 6 Weeks Assessed
measure: Safety assessment - Triglycerides
timeFrame: From Baseline to 6 Weeks Assessed
measure: Safety assessment - LDL
timeFrame: From Baseline to 6 Weeks Assessed
measure: Safety assessment - HDL
timeFrame: From Baseline to 6 Weeks Assessed
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: National Taiwan Sport University
Study officials:
affiliation: National Taiwan Sport University
name: Chi-Chang Huang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: