Weizmannia Coagulans BC99 Relieves Exercise-induced Fatigue

NCT ID: NCT07325422

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-03-30

Brief Summary

To evaluate the clinical effects of Weizmannia coagulans BC99 supplementation compared with placebo on plasma amino acid profiles in male university students following a 12-week intervention.

Conditions

College Student

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo group

3g dose of milk protein concentrate/pack, 8 packs per day

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

The experimental phase of this study lasts 12 weeks and each subject will have 3 visits (Week 0, Week 6, Week 12)

BC99 group

3g dose of milk protein concentrate with 6×109 Colony Forming Unit (CFU) W. coagulans BC99/pack, 8 packs per day

Group Type: EXPERIMENTAL

BC99

Intervention Type: DIETARY_SUPPLEMENT

The experimental phase of this study lasts 12 weeks and each subject will have 3 visits (Week 0, Week 6, Week 12)

Interventions

Placebo

The experimental phase of this study lasts 12 weeks and each subject will have 3 visits (Week 0, Week 6, Week 12)

Intervention Type: DIETARY_SUPPLEMENT

BC99

The experimental phase of this study lasts 12 weeks and each subject will have 3 visits (Week 0, Week 6, Week 12)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Healthy adults aged 19-35 years, with no restriction on sex;

2. Physically active individuals with regular daily exercise training intensity and duration;

3. No history of allergy to protein products;

4. Body weight ≥50 kg for male subjects and ≥45 kg for female subjects; body mass index (BMI), calculated as weight (kg) divided by height squared (m²), within the range of 19.0-24.0 kg/m²;

5. No history of cardiovascular or cerebrovascular diseases, hypertension, diabetes, hepatic or renal dysfunction, or other underlying diseases or metabolic disorders;

6. Willingness to comply with the study protocol and study restrictions, and voluntary provision of written informed consent to participate in the study.

Exclusion Criteria

1. History of allergic constitution or immunodeficiency;

2. Blood donation or significant blood loss (≥200 mL) within 3 months prior to administration of the investigational product;

3. Presence of severe diseases of major organs, including the cardiovascular system, lungs, liver, or kidneys, as well as diabetes mellitus, severe thyroid disorders, metabolic diseases, malignant tumors, or severe immune system diseases;

4. Use of medications affecting the intestinal microbiota (including antibiotics, microecological preparations, intestinal mucosal protectants, traditional Chinese medicines, etc.) for more than one consecutive week within 1 month prior to screening;

5. Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wecare Probiotics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Wu Ying

Luoyang, Henan, China

Countries

China

Other Identifiers

WK20251226

Identifier Type: -

Identifier Source: org_study_id