the Role of Probiotic in Protein Metabolism

NCT ID: NCT06307821

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-25
• Study Completion Date: 2024-07-30

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Probiotics

48 billion CFU/day BC99 and protein powder; Storage: sealed, protected from light, placed in a cool and dry place.

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

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.

placebo

Protein powder, 8 bags per day; Storage: sealed, protected from light, placed in a cool and dry place.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

Probiotic

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wecare Probiotics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Henan University of Science and Technology

Luoyang, Henan, China

Countries

China

Other Identifiers

WK2024002

Identifier Type: -

Identifier Source: org_study_id