NCT07325409已完成不适用
Sports Nutrition Benefits of Weizmannia Coagulans BC99: a Randomized Controlled Trial on Muscle Function and Recovery in Healthy Participants
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
- Pain evaluation
研究概览
简要总结
To evaluate the clinical efficacy of Weizmannia coagulans BC99 in young Chinese patients with exercise-induced muscle damage compared with placebo, and to explore its effects on inflammatory responses and intestinal microbiota.
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
Pain evaluation
时间窗: 12 weeks
Visual analog scale (VAS) was used for assessing the pain level of muscle, ranging from 0 to 10 point (0 means no pain; 10 represent worst imaginable pain). VAS scores were recorded at 24h, 48h and 72h after the intense exercise work stress.
次要结局
- Cortisol in plasma(12 weeks)
- Peptide YY in plasma(12 weeks)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
不适用
Effect of Protein Supplementation and Fluid Restriction on Plasma Sodium Levels in Patients Undergoing Pituitary SurgeryHyponatremiaNCT07273630University Hospital, Basel, Switzerland282
尚未招募
不适用
The Effect of Supplementary Foods Containing Trypsin, Chymotrypsin and Serratia Peptidase on Healing After Impacted Wisdom Tooth SurgeryNCT07269171Saglik Bilimleri Universitesi15
尚未招募
不适用
Effect of a Dietary Supplement Containing EGCG, Folic Acid, Vitamin B12 and Hyaluronic Acid in Supporting Male Genital Balance in Subjects Exposed to HPV RiskNCT07320183Fondazione Policlinico Universitario Agostino Gemelli IRCCS96
已完成
不适用
Effects of L-carnitine and Coenzyme Q10 Supplementation on Oxidative Stress in Tunisian Hemodialysis Patients.NCT07303088University of Sfax52
尚未招募
1 期
Chinese Herbal Therapy (Qiqi Shengmai Formula) for Moyamoya Vasculopathy: The CHIMES TrialNCT07286110Fudan University66