the Role of Probiotic in Protein Metabolism
September 25, 2025 updated by: Wecare Probiotics Co., Ltd.
Assessing the Impact of Weizmannella Coagulans BC99 on Protein Digestion and Metabolism: A Randomized, Double-Blind Controlled Trial
This study investigates the functional effects of probiotics on athletes by administering Weizmannella coagulans BC99 for 12 weeks.
It aims to assess the probiotic's influence on skeletal muscle content, athletic performance, and protein digestion and metabolism.
This is achieved by monitoring changes in digestive enzymes, amino acids, body composition, and hormone levels.
The research seeks to offer a theoretical foundation for optimizing athletes' training and nutrition strategies and suggests the potential of probiotics in enhancing nutrient absorption and utilization, particularly in individuals with compromised digestive capabilities.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Henan
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Luoyang, Henan, China, 471000
- Henan University of Science and Technology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Voluntarily, in writing, and signing the informed consent form, agreeing to participate in this study;
- Agree to abide by the protocol and study restrictions;
- The subject is not allergic to protein products;
- Male or female subjects aged 18 to 35 years old (including 18 and 35 years old);
- 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;
- No history of hidden risks of cardiovascular and cerebrovascular diseases, hypertension, diabetes, liver/kidney function, etc. and metabolic abnormalities.
Exclusion Criteria:
- Patients with allergies and immune deficiency;
- Donated blood or lost a large amount of blood (≥200 mL) within 3 months before taking the trial drug;
- 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.
- 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;
- Subjects judged by other researchers to be unfit to participate.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: placebo
Protein powder, 8 bags per day; Storage: sealed, protected from light, placed in a cool and dry place.
|
The intervention lasts for 12 weeks, with follow-ups conducted at weeks 0, 6, and 12 to assess participants' digestion and absorption rates of dietary protein, as well as to collect fecal samples for analysis of changes in the gut microbiota.
|
|
Experimental: Probiotics
48 billion CFU/day BC99 and protein powder; Storage: sealed, protected from light, placed in a cool and dry place.
|
The intervention lasts for 12 weeks, with follow-ups conducted at weeks 0, 6, and 12 to assess participants' digestion and absorption rates of dietary protein, as well as to collect fecal samples for analysis of changes in the gut microbiota.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Digestibility and absorption of dietary protein
Time Frame: 12 weeks
|
After probiotic intervention, calculate the changes in subjects' digestibility and absorption rate of dietary protein based on baseline
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 25, 2024
Primary Completion (Actual)
April 25, 2024
Study Completion (Actual)
July 30, 2024
Study Registration Dates
First Submitted
March 6, 2024
First Submitted That Met QC Criteria
March 6, 2024
First Posted (Actual)
March 13, 2024
Study Record Updates
Last Update Posted (Estimated)
October 1, 2025
Last Update Submitted That Met QC Criteria
September 25, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WK2024002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.