Effects of Lactobacillus Paracasei PS23 on Anti-fatigue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The Countermovement Jump (CMJ) Test
研究概览
简要总结
This research is to explore the effects of supplementing Lactobacillus paracasei PS23 to reduce fatigue and improve physical fitness after exhaustive exercise.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult men and women aged 20-40 who are generally non-athletic players
排除标准
- •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
研究组 & 干预措施
placebo
The placebo capsule contains microcrystalline cellulose, 2 caps daily use.
干预措施: PS23 (Dietary Supplement)
heat-treated PS23
PS23 heat-treated, 2 caps daily use.
干预措施: PS23 (Dietary Supplement)
PS23
The PS23 belongs to Lactobacillus paracasei group, 2 caps daily use.
干预措施: PS23 (Dietary Supplement)
结局指标
主要结局
The Countermovement Jump (CMJ) Test
时间窗: 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.
Isometric Mid-Thigh Pull (IMTP)
时间窗: 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.
Stress assessment - difference of Testosterone level
时间窗: 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
Difference in Clinical Biochemistry of CK level
时间窗: 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).
Difference of Muscle damage - blood level of myoglobin
时间窗: 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
Oxidative stress assessment - blood of MDA level
时间窗: From Baseline to 6 Weeks Assessed
comparing blood levels of oxidative markers such as Malondialdehyde (MDA)
Difference in Oxidative stress - blood level of CRP
时间窗: 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
Wingate Anaerobic Test (WAnT)
时间窗: 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.
Isometric Mid-Thigh Pull (IMTP)
时间窗: 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.
次要结局
- Safety assessment - Glucose(From one week before Baseline to 6 Weeks Assessed)
- Safety assessment - HDL(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)
- Gut microbiota(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)
- Change in Patient Global Impression of Change (PGIC)(From Baseline to 6 Weeks Assessed)
- Safety assessment - AST(From Baseline to 6 Weeks Assessed)
- Safety assessment - ALT(From Baseline to 6 Weeks Assessed)
- Safety assessment - T-Cholesterol(From Baseline to 6 Weeks Assessed)
- Safety assessment - Uric Acid(From Baseline to 6 Weeks Assessed)
- Safety assessment - Bun(From Baseline to 6 Weeks Assessed)
- Safety assessment - Creatinine(From Baseline to 6 Weeks Assessed)
- Safety assessment - Triglycerides(From Baseline to 6 Weeks Assessed)
- Safety assessment - LDL(From Baseline to 6 Weeks Assessed)
研究者
Chi-Chang Huang
Principal Investigator
National Taiwan Sport University
