Skip to main content
Clinical Trials/NCT07325422
NCT07325422CompletedNot Applicable

Weizmannia Coagulans BC99 Relieves Exercise-induced Fatigue: a Randomized Controlled Trial

Wecare Probiotics Co., Ltd.2 sites in 1 country72 target enrollmentStarted: November 1, 2023Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
72
Locations
2
Primary Endpoint
Changes of amino acids

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Healthy adults aged 19-35 years, with no restriction on sex;
  • Physically active individuals with regular daily exercise training intensity and duration;
  • No history of allergy to protein products;
  • 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;
  • No history of cardiovascular or cerebrovascular diseases, hypertension, diabetes, hepatic or renal dysfunction, or other underlying diseases or metabolic disorders;
  • Willingness to comply with the study protocol and study restrictions, and voluntary provision of written informed consent to participate in the study.

Exclusion Criteria

  • History of allergic constitution or immunodeficiency;
  • Blood donation or significant blood loss (≥200 mL) within 3 months prior to administration of the investigational product;
  • 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;
  • 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;
  • Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in the study.

Arms & Interventions

Placebo group

Placebo Comparator

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

Intervention: Placebo (Dietary Supplement)

BC99 group

Experimental

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

Intervention: BC99 (Dietary Supplement)

Outcomes

Primary Outcomes

Changes of amino acids

Time Frame: 12 weeks

Plasma amino acid changes were determined by targeted UHPLC-MS/MS analysis using isotope-labeled internal standards and quality control samples to ensure analytical accuracy and reproducibility.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

Loading locations...

Similar Trials