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临床试验/NCT06092723
NCT06092723已完成不适用

Effects of Lactococcus Lactics Subsp. Lactics, LY-66, Lactobacillus Plantarum, PL-02, and Combination LY-66+PL-02 Improves the Endurance and Explosiveness Exercise Performance on Healthy Human.

Glac Biotech Co., Ltd2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
88
试验地点
2
主要终点
Compare the enhancing endurance performance in sports.

研究概览

简要总结

This study may discover that supplementing with probiotics LY-66, PL-02 can promote exercise endurance, explosive power and reduce muscle inflammation index in healthy people.

详细描述

With the rise of people's health awareness and exercise habit in recent years, and the demand for the use of sports health food supplements has also increased. Probiotics are generally recognized as safe and helpful in digestion in the gastrointestinal tract. Previous animal experiments have found that probiotics LY-66, PL-02 are more effective in promoting the grip and exhausting exercise in mice. The purpose of this study is to further explore the effects of probiotics LY-66, PL-02 on promoting exercise endurance and explosive power in healthy people. This study is to compare supplementary samples with placebo and adopt a double-blind study design. 88 healthy adult males and females (non-sports players) aged 20-40 will be recruited, 44males and 44 females, with an average number of male and female subjects in each group, and they will be randomly assigned to the (A) placebo group, (B) LY-66 probiotic group, (C) PL-02 probiotics group, (D) LY-66/PL-02 doublet probiotics group. Supplemented one time a day, take 15 billion CFU of probiotics each time for 42 consecutive days. During the period of taking probiotics, squats and TABATA training were set for the subjects 2 days a week. From day 0 to day 42 of supplementation, subjects in each group were tested physical fitness and cardiorespiratory endurance every 14 days. On the 21th days, the explosiveness of muscle strength in each group was tested with Wingate. On the 42nd day, the exercise endurance test, NGS and GC-MS technology was used to detect the fecal microbiota and SCFA(Short-chain fatty acids) in each group, body inflammation index of each group were tested and use questionnaire to evaluate subjective experience. This study may discover that supplementing with probiotics LY-66, PL-02 can promote exercise endurance, explosive power and reduce muscle inflammation index in healthy people.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy adult
  • Not professional athletes

排除标准

  • The patient who Smoking.
  • The patient have cardiovascular disease
  • The patient have hyertension
  • The patient BMI>27
  • The patient have metabolic diseases
  • The patient have asthma
  • The patient who have experienced limb, neuromuscular, or exercise-related injuries within the past 6 months,.
  • The patient have taken anti-inflammatory or pain-relief medication in the past month,
  • The patient have consumed probiotic-related products will be excluded.
  • Students under the supervision of the principal investigator and individuals with conflicts of interest .

结局指标

主要结局

Compare the enhancing endurance performance in sports.

时间窗: before、Week6

The Isometric Mid-Thigh Pull (IMTP) is a reliable and valid test that can be used to measure maximal force using a custom-made IMTP test device and a force plate. The measured parameters are Peak Force ( the maximum value of force)

Wingate Anaerobic test

时间窗: before、Week 3、Week6

Use an anaerobic power bicycle and sprint at full speed for 30 seconds. The measured parameters are Peak power (peak power output, which is the output during the test).

Compare muscle gain and fat loss.

时间窗: before、Week 0、Week 2、Week4、Week6

Use body fat meter to measure body composition.

Compare the enhancing explosive power performance in sports.

时间窗: before、Week 3、Week6

Using a force plate and an infrared high-speed camera, a light ball was installed on the subject, and the subject was asked to jump three times at their maximum ability. The maximum jumping force is calculated based on the distance of optical capture displacement.

Changes in maximal oxygen uptake(VO2 max)

时间窗: before、Week6

When the heart rate reaches 170 beats per minute, start collecting gas until exhaustion. The collected gas is used to calculate VO2max through a gas analyzer. The standard for judging exercise exhaustion is that two of the following three conditions are met: (A) The heart rate reaches the maximum heart rate (maximum heart rate = 220 - age). (B) The subject's respiratory exchange rate reaches 1.1. (C) The subject's self-motivated expression of exercise is above 18.

次要结局

  • Changes in sleep quality(Week0、Week3、Week6)
  • Changes in stool form.(Before、Week 6)
  • Changes in immune Index (pg/ml).(Before、Week 6)

研究者

申办方类型
Industry
责任方
Principal Investigator
主要研究者

Hsieh-Hsun Ho

R & D director

Glac Biotech Co., Ltd

研究点 (2)

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