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Exercise PerformanceNCT06092723

Effects of Probiotics Improves the Endurance and Explosiveness Exercise Performance on Healthy Human.

A study testing Probiotic 1,Lactococcus lactis subsp. lactis, LY-66, Probiotic 2,Lactobacillus plantarum, PL-02 and Probiotic 3,Lactococcus lactis subsp. lactis, LY-66+Lactobacillus plantarum, PL-02 in people with Exercise Performance, run by Glac Biotech Co., Ltd at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Exercise Performance
What is being tested?
Probiotic 1,Lactococcus lactis subsp. lactis, LY-66, Probiotic 2,Lactobacillus plantarum, PL-02 and Probiotic 3,Lactococcus lactis subsp. lactis, LY-66+Lactobacillus plantarum, PL-02
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
88 participants
Where
1 siteTaiwan
Study dates
1 Dec 2021to 7 Feb 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy adult
  • Age 20-40
  • Not professional athletes

Who cannot join

  • 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
Show all 10Show fewer
  • 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 .

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Glac Biotech Co., Ltd.

    Tainan, 74442

Other trials in Taiwan

About this study

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.

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.

Read the 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.

Being tested
Placebo, Probiotic 1,Lactococcus lactis subsp. lactis, LY-66, Probiotic 2,Lactobacillus plantarum, PL-02, Probiotic 3,Lactococcus lactis subsp. lactis, LY-66+Lactobacillus plantarum, PL-02
Keywords
Probiotics, Intestinal flora, Exercise Performance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDietary supplement

    Subjects take two packs once a day, and make a 250 ml water solution for drinking.

  • Probiotic 1,Lactococcus lactis subsp. lactis, LY-66Dietary supplement

    Subjects take two packs once a day, and make a 250 ml water solution for drinking.

  • Probiotic 2,Lactobacillus plantarum, PL-02Dietary supplement

    Subjects take two packs once a day, and make a 250 ml water solution for drinking.

  • Probiotic 3,Lactococcus lactis subsp. lactis, LY-66+Lactobacillus plantarum, PL-02Dietary supplement

    Subjects take two packs once a day, and make a 250 ml water solution for drinking.

Study groups in NCT06092723
Study groupRoleWhat they receive
Lactococcus lactis subsp. lactis, LY-66ExperimentalSubjects take two packs once a day, and make a 250 ml water solution for drinking.
Receives: Dietary Supplement: Probiotic 1,Lactococcus lactis subsp. lactis, LY-66
Lactobacillus plantarum, PL-02ExperimentalSubjects take two packs once a day, and make a 250 ml water solution for drinking.
Receives: Dietary Supplement: Probiotic 2,Lactobacillus plantarum, PL-02
Lactococcus lactis subsp. lactis, LY-66+Lactobacillus plantarum, PL-02ExperimentalSubjects take two packs once a day, and make a 250 ml water solution for drinking.
Receives: Dietary Supplement: Probiotic 3,Lactococcus lactis subsp. lactis, LY-66+Lactobacillus plantarum, PL-02
PlaceboPlacebo comparatorSubjects take two packs once a day, and make a 250 ml water solution for drinking.
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compare the enhancing endurance performance in sports.

    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)

    Measured: before、Week6

  2. Wingate Anaerobic test

    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).

    Measured: before、Week 3、Week6

  3. Compare muscle gain and fat loss.

    Use body fat meter to measure body composition.

    Measured: before、Week 0、Week 2、Week4、Week6

  4. Compare the enhancing explosive power performance in sports.

    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.

    Measured: before、Week 3、Week6

  5. Changes in maximal oxygen uptake(VO2 max)

    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.

    Measured: before、Week6

Secondary outcomes (4)

  1. Changes in sleep quality

    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.

    Measured: Week0、Week3、Week6

  2. Changes in stool form.

    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))

    Measured: Before、Week 6

  3. Changes in immune Index (pg/ml).

    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.

    Measured: before the exhaustive exercise and 3 hours、24hours、48hours after the exhaustive exercise.

  4. Changes in immune Index (pg/ml).

    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.

    Measured: Before、Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2023
  2. Study start1 Dec 2021
  3. Primary completion7 Feb 2023
  4. Study completion7 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06092723
Sponsor's protocol ID
LSHIRB21-042-A2
Status last verified
Oct 2023
First submitted
28 Sep 2023
Last updated
23 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Probiotic 1,Lactococcus lactis subsp. lactis, LY-66, Probiotic 2,Lactobacillus plantarum, PL-02 and Probiotic 3,Lactococcus lactis subsp. lactis, LY-66+Lactobacillus plantarum, PL-02 in people with Exercise Performance, run by Glac Biotech Co., Ltd at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare the enhancing endurance performance in sports. (time frame: before、Week6). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06092723.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.

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