the Role of Probiotic in Protein Metabolism

NCT06307821 | Completed

• 1 other identifier: WK2024002
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Keywords

Probiotic; Protein digestion

Outcome Measures

Primary Outcomes (1)

• Digestibility and absorption of dietary protein

  After probiotic intervention, calculate the changes in subjects' digestibility and absorption rate of dietary protein based on baseline

  12 weeks

Study Arms (2)

Probiotics

EXPERIMENTAL

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

Dietary Supplement: Probiotic

placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Probiotic 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.

Probiotics

Placebo 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

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

Henan University of Science and Technology

Luoyang, Henan, 471000, China

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double（Participant,Investigator）
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 13, 2024
• Study Start: February 25, 2024
• Primary Completion: April 25, 2024
• Study Completion: July 30, 2024
• Last Updated: October 1, 2025

Record last verified: 2025-03

Locations

CN (1)