College Student
Conditions
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.
Interventions
DIETARY_SUPPLEMENTPlacebo
The experimental phase of this study lasts 12 weeks and each subject will have 3 visits (Week 0, Week 6, Week 12)
DIETARY_SUPPLEMENTBC99
The experimental phase of this study lasts 12 weeks and each subject will have 3 visits (Week 0, Week 6, Week 12)
Sponsors
Wecare Probiotics Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of amino acids | 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. |
Countries
China
Outcome results
None listed