NCT07325422已完成不适用
Weizmannia Coagulans BC99 Relieves Exercise-induced Fatigue: a Randomized Controlled Trial
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Changes of amino acids
研究概览
简要总结
To evaluate the clinical effects of Weizmannia coagulans BC99 supplementation compared with placebo on plasma amino acid profiles in male university students following a 12-week intervention.
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)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 19-35 years, with no restriction on sex;
- •Physically active individuals with regular daily exercise training intensity and duration;
- •No history of allergy to protein products;
- •Body weight ≥50 kg for male subjects and ≥45 kg for female subjects; body mass index (BMI), calculated as weight (kg) divided by height squared (m²), within the range of 19.0-24.0 kg/m²;
- •No history of cardiovascular or cerebrovascular diseases, hypertension, diabetes, hepatic or renal dysfunction, or other underlying diseases or metabolic disorders;
- •Willingness to comply with the study protocol and study restrictions, and voluntary provision of written informed consent to participate in the study.
排除标准
- •History of allergic constitution or immunodeficiency;
- •Blood donation or significant blood loss (≥200 mL) within 3 months prior to administration of the investigational product;
- •Presence of severe diseases of major organs, including the cardiovascular system, lungs, liver, or kidneys, as well as diabetes mellitus, severe thyroid disorders, metabolic diseases, malignant tumors, or severe immune system diseases;
- •Use of medications affecting the intestinal microbiota (including antibiotics, microecological preparations, intestinal mucosal protectants, traditional Chinese medicines, etc.) for more than one consecutive week within 1 month prior to screening;
- •Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in the study.
研究组 & 干预措施
Placebo group
Placebo Comparator
3g dose of milk protein concentrate/pack, 8 packs per day
干预措施: Placebo (Dietary Supplement)
BC99 group
Experimental
3g dose of milk protein concentrate with 6×109 Colony Forming Unit (CFU) W. coagulans BC99/pack, 8 packs per day
干预措施: BC99 (Dietary Supplement)
结局指标
主要结局
Changes of amino acids
时间窗: 12 weeks
Plasma amino acid changes were determined by targeted UHPLC-MS/MS analysis using isotope-labeled internal standards and quality control samples to ensure analytical accuracy and reproducibility.
次要结局
未报告次要终点
研究者
研究点 (2)
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