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
- Sponsor
- Wecare Probiotics Co., Ltd.
- 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
Study Sites (2)
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