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临床试验/NCT06307821
NCT06307821已完成不适用

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

Wecare Probiotics Co., Ltd.1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年2月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
1
主要终点
Digestibility and absorption of dietary protein

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

Double(Participant,Investigator)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Digestibility and absorption of dietary protein

时间窗: 12 weeks

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

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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