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Completed

NCT Number: NCT06307821

the Role of Probiotic in Protein Metabolism

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.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henan University of Science and Technology

Luoyang, Henan, 471000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

Assessing the Impact of Weizmannella Coagulans BC99 on Protein Digestion and Metabolism: A Randomized, Double-Blind Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 13, 2024
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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