NCT06092723

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

1.2 years

First QC Date

September 28, 2023

Last Update Submit

October 15, 2023

Conditions

Keywords

ProbioticsIntestinal floraExercise Performance

Outcome Measures

Primary Outcomes (5)

  • 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)

    before、Week6

  • 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).

    before、Week 3、Week6

  • Compare muscle gain and fat loss.

    Use body fat meter to measure body composition.

    before、Week 0、Week 2、Week4、Week6

  • 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.

    before、Week 3、Week6

  • 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.

    before、Week6

Secondary Outcomes (4)

  • Changes in sleep quality

    Week0、Week3、Week6

  • Changes in stool form.

    Before、Week 6

  • Changes in immune Index (pg/ml).

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

  • Changes in immune Index (pg/ml).

    Before、Week 6

Study Arms (4)

Lactococcus lactis subsp. lactis, LY-66

EXPERIMENTAL

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

Dietary Supplement: Probiotic 1,Lactococcus lactis subsp. lactis, LY-66

Lactobacillus plantarum, PL-02

EXPERIMENTAL

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

Dietary Supplement: Probiotic 2,Lactobacillus plantarum, PL-02

Lactococcus lactis subsp. lactis, LY-66+Lactobacillus plantarum, PL-02

EXPERIMENTAL

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

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

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

PlaceboDIETARY_SUPPLEMENT

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

Placebo

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

Lactococcus lactis subsp. lactis, LY-66

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

Lactobacillus plantarum, PL-02

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

Lactococcus lactis subsp. lactis, LY-66+Lactobacillus plantarum, PL-02

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glac Biotech Co., Ltd.

Tainan, 74442, Taiwan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
R & D director

Study Record Dates

First Submitted

September 28, 2023

First Posted

October 23, 2023

Study Start

December 1, 2021

Primary Completion

February 7, 2023

Study Completion

February 7, 2023

Last Updated

October 23, 2023

Record last verified: 2023-10

Locations