Effects of Lactobacillus Paracasei PS23 on Anti-fatigue

NCT ID: NCT05346432

Last Updated: 2022-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2022-07-10

Brief Summary

This research is to explore the effects of supplementing Lactobacillus paracasei PS23 to reduce fatigue and improve physical fitness after exhaustive exercise.

Detailed Description

Studies have found that the intestinal flora of athletes is different from that of ordinary people, and short-chain fatty acids play a very important role. Previous animal experiments have found that supplementing with specific probiotics can slow down muscle loss in aging mice. In addition, clinical studies have found that supplementing with probiotics can improve sports performance by regulating the intestinal flora and related metabolites. Therefore, the purpose of this research is to explore the effects of supplementing Lactobacillus paracasei PS23 to reduce fatigue and improve physical fitness after exhaustive exercise. This study compares supplementary samples with placebo and adopts a double-blind study design.

Conditions

Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

PS23

The PS23 belongs to Lactobacillus paracasei group, 2 caps daily use.

Group Type: EXPERIMENTAL

PS23

Intervention Type: DIETARY_SUPPLEMENT

PS23 belongs to Lactobacillus paracasei group.Probiotic capsules contain 10 billion CFU (colony forming units) of PS23

heat-treated PS23

PS23 heat-treated, 2 caps daily use.

Group Type: EXPERIMENTAL

PS23

Intervention Type: DIETARY_SUPPLEMENT

PS23 belongs to Lactobacillus paracasei group.Probiotic capsules contain 10 billion CFU (colony forming units) of PS23

placebo

The placebo capsule contains microcrystalline cellulose, 2 caps daily use.

Group Type: PLACEBO_COMPARATOR

PS23

Intervention Type: DIETARY_SUPPLEMENT

PS23 belongs to Lactobacillus paracasei group.Probiotic capsules contain 10 billion CFU (colony forming units) of PS23

Interventions

PS23

PS23 belongs to Lactobacillus paracasei group.Probiotic capsules contain 10 billion CFU (colony forming units) of PS23

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Healthy adult men and women aged 20-40 who are generally non-athletic players

Exclusion Criteria

• BMI≧27
• Known allergy to probiotics
• Have current or history of inflammatory bowel disease
• Patients using of other probiotic products (sachet, capsule or tablet) within the preceding two weeks
• Those who have taken medication such as anti-inflammatory pain killer or antibiotics in the past one month
• smoker and alcoholic
• Who have been injured within 6 months
• Who has been diagnosed and treated of cardiovascular disease, hypertension, metabolic disease, asthma, or cancer
• Have undergone surgery of liver, bladder, or gastrointestinal tract
• Who has conflict of interest with PI

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bened Biomedical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Chi-Chang Huang

OTHER

Sponsor Role: lead

Responsible Party

Chi-Chang Huang

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Chi-Chang Huang, Ph.D

Role: PRINCIPAL_INVESTIGATOR

National Taiwan Sport University

Locations

National Taiwan Sport University

Taoyuan District, , Taiwan

Countries

Taiwan

Other Identifiers

22-003-A2

Identifier Type: -

Identifier Source: org_study_id