Investigating the effects of probiotics on protein metabolism in athletes
Assessing the Impact of Weizmannella Coagulans BC99 on Protein Digestion and Metabolism: A Randomized, Double-Blind Controlled Trial
This study is testing whether a probiotic can help athletes improve their protein digestion and metabolism to boost their training and performance.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | All |
| Sponsor | Wecare Probiotics Co., Ltd. Industry-sponsored |
| Locations | 1 site (Luoyang, Henan) |
| Trial ID | NCT06307821 on ClinicalTrials.gov |
What this trial studies
This study examines how the probiotic Weizmannella coagulans BC99 affects protein digestion and metabolism in healthy athletes over a six-week period. Participants will be monitored for changes in digestive enzymes, amino acids, body composition, and hormone levels to assess the probiotic's impact on skeletal muscle content and athletic performance. The goal is to provide insights that could enhance training and nutrition strategies for athletes, particularly those with digestive challenges.
Who should consider this trial
Good fit: Ideal candidates are healthy male and female athletes aged 18 to 35 with a normal BMI and no history of significant health issues.
Not a fit: Patients with allergies, immune deficiencies, or systemic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve athletic performance and nutrient absorption for athletes through enhanced protein metabolism.
How similar studies have performed: While the specific approach of this study may be novel, previous research has indicated potential benefits of probiotics in digestive health and athletic performance.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Voluntarily, in writing, and signing the informed consent form, agreeing to participate in this study; 2. Agree to abide by the protocol and study restrictions; 3. The subject is not allergic to protein products; 4. Male or female subjects aged 18 to 35 years old (including 18 and 35 years old); 5. Male subjects should weigh no less than 50 kilograms. Female subjects must weigh no less than 45 kg. Body mass index (BMI) = weight (kg)/height (m)2, body mass index is in the range of 19.0 to 24.0 kg/m2; 6. No history of hidden risks of cardiovascular and cerebrovascular diseases, hypertension, diabetes, liver/kidney function, etc. and metabolic abnormalities. Exclusion Criteria: 1. Patients with allergies and immune deficiency; 2. Donated blood or lost a large amount of blood (≥200 mL) within 3 months before taking the trial drug; 3. Other systemic diseases, including cardiovascular disease, lung disease, liver disease, kidney disease and other serious lesions of important organs, severe metabolic diseases (diabetes, thyroid disease), severe immune system diseases; no cardiovascular and cerebrovascular diseases, hypertension , diabetes, liver/kidney function and other hidden dangers and metabolic abnormalities. 4. Drugs that affect intestinal flora (including antibacterial drugs, microecological preparations, intestinal mucosal protective agents, Chinese patent medicines, etc.) have been used continuously for more than 1 week within 1 month before screening; 5. Subjects judged by other researchers to be unfit to participate.
Where this trial is running
Luoyang, Henan
- Henan University of Science and Technology — Luoyang, Henan, China (Recruiting)
Study contacts
- Study coordinator: Ying Wu
- Email: wuying2000@126.com
- Phone: +86 18639283502
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.