Clinical trial NCT06092723: Effects of Probiotics Improves the Endurance and Explosiveness Exercise Performance on Healthy Human.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Performance
Keywords: Probiotics
Intestinal flora
Exercise Performance
Lead sponsor: Glac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-10-23
Enrollment: 88
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Healthy adult
2. Age 20-40
3. Not professional athletes

Exclusion Criteria:

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

Primary outcomes:
measure: Compare the enhancing endurance performance in sports.
timeFrame: before、Week6
measure: Wingate Anaerobic test
timeFrame: before、Week 3、Week6
measure: Compare muscle gain and fat loss.
timeFrame: before、Week 0、Week 2、Week4、Week6
measure: Compare the enhancing explosive power performance in sports.
timeFrame: before、Week 3、Week6
measure: Changes in maximal oxygen uptake(VO2 max)
timeFrame: before、Week6
Secondary outcomes:
measure: Changes in sleep quality
timeFrame: Week0、Week3、Week6
measure: Changes in stool form.
timeFrame: Before、Week 6
measure: Changes in immune Index (pg/ml).
timeFrame: before the exhaustive exercise and 3 hours、24hours、48hours after the exhaustive exercise.
measure: Changes in immune Index (pg/ml).
timeFrame: Before、Week 6
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Glac Biotech Co., Ltd.
Study officials:
References: