- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06092723
Effects of Probiotics Improves the Endurance and Explosiveness Exercise Performance on Healthy Human.
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 Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Tainan, Taiwan, 74442
- Glac Biotech Co., Ltd.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy adult
- Age 20-40
- Not professional athletes
Exclusion Criteria:
- 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 .
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lactococcus lactis subsp. lactis, LY-66
Subjects take two packs once a day, and make a 250 ml water solution for drinking.
|
Subjects take two packs once a day, and make a 250 ml water solution for drinking.
|
Experimental: Lactobacillus plantarum, PL-02
Subjects take two packs once a day, and make a 250 ml water solution for drinking.
|
Subjects take two packs once a day, and make a 250 ml water solution for drinking.
|
Experimental: Lactococcus lactis subsp. lactis, LY-66+Lactobacillus plantarum, PL-02
Subjects take two packs once a day, and make a 250 ml water solution for drinking.
|
Subjects take two packs once a day, and make a 250 ml water solution for drinking.
|
Placebo Comparator: Placebo
Subjects take two packs once a day, and make a 250 ml water solution for drinking.
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Subjects take two packs once a day, and make a 250 ml water solution for drinking.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare the enhancing endurance performance in sports.
Time Frame: 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)
|
before、Week6
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Wingate Anaerobic test
Time Frame: before、Week 3、Week6
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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).
|
before、Week 3、Week6
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Compare muscle gain and fat loss.
Time Frame: before、Week 0、Week 2、Week4、Week6
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Use body fat meter to measure body composition.
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before、Week 0、Week 2、Week4、Week6
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Compare the enhancing explosive power performance in sports.
Time Frame: 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.
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before、Week 3、Week6
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Changes in maximal oxygen uptake(VO2 max)
Time Frame: 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. |
before、Week6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in sleep quality
Time Frame: Week0、Week3、Week6
|
The ratio of deep sleep to light sleep in sleep was record before and during the trial.
Changes in PITTSBURGH SLEEP QUALITY INDEX (PSQI) scores were record at before and after intervention.
The minimum value is "0" and maximum value is "72", higher scores mean a worse outcome.
|
Week0、Week3、Week6
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Changes in stool form.
Time Frame: Before、Week 6
|
Record the stool form at before anf week 6.Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools as they are easy to defecate while not containing excess liquid, 5 indicating lack of dietary fiber, and 6 and 7 indicate diarrhoea.(Type
1: Separate hard lumps, like nuts (difficult to pass)、Type 2: Sausage-shaped, but lumpy、Type 3: Like a sausage but with cracks on its surface、Type 4: Like a sausage or snake, smooth and soft (average stool)、Type 5: Soft blobs with clear cut edges、Type 6: Fluffy pieces with ragged edges, a mushy stool (diarrhea)、Type 7: Watery, no solid pieces, entirely liquid (diarrhea))
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Before、Week 6
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Changes in immune Index (pg/ml).
Time Frame: before the exhaustive exercise and 3 hours、24hours、48hours after the exhaustive exercise.
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Exercise program to induce muscle fatigue and soreness This exercise program for inducing muscle fatigue and soreness involves 100 repeated jumps. Divide 100 jumps into 10 groups, 10 times each, and complete one jump in 4 seconds each time. Changes in Creatine kinase、Cortisol、IL-6 were assessed before the exhaustive exercise and 3 hours、24hours、48hours after the exhaustive exercise. |
before the exhaustive exercise and 3 hours、24hours、48hours after the exhaustive exercise.
|
Changes in immune Index (pg/ml).
Time Frame: Before、Week 6
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Changes in AST、ALT、blood urea nitrogen, creatinine, uric acid, ketone bodies, total protein, total cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein, glucose, serotonin, melanin and short-chain fatty acid concentrations were assessed before and week 6.
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Before、Week 6
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- LSHIRB21-042-A2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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