A prospective, randomized, double-blind, placebo-controlled parallel-group clinical trial to evaluate the effects of a Bacillus coagulans-based product on protein digestion and utilization in gastro-intestinal tract.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Difference in the Creatine Kinase and CRP levels
研究概览
简要总结
Probiotics are live microorganisms promoted with claims that they provide health benefits when consumed, generally by improving or restoring the gut flora. Probiotics are live bacteria and yeasts that are good us especially for the digestive system.
Probiotics are considered generally safe to consume. Probiotics had a positive significant effect across all eight gastrointestinal diseases with a relative risk of 0.58 (95% (CI) 0.51–0.65). Six of the eight diseases: Pouchitis, Infectious diarrhoea, Irritable Bowel Syndrome, Helicobacter pylori, Clostridium difficile Disease, and Antibiotic Associated Diarrhea, showed positive significant effects.
The sponsor has developed the probiotic strain of BC, called as ProBCPlus. The aim of the current clinical trial is to evaluate the effects of a Bacillus coagulans-based product on protein digestion and utilization in gastro-intestinal tract in healthy human volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Subject has provided written and dated informed consent to participate in the study.
- •Subject is willing and able to comply with the protocol.
- •Healthy male/female of age 18-60 years.
- •Subject is in good health as determined by a health history questionnaire.
- •Subject ready to follow the diet and exercise regime.
- •Subject is untrained in resistance/power exercise.
排除标准
- •Subject on protein and/ or probiotic rich diet.
- •Subject is participating in another clinical trial or has received an investigational product within thirty days prior to enrolment.
- •Subject has a history of alcohol or other drug abuse in the past year
- •Subject has a significant history or current presence of treated or untreated bleeding disorder, diabetes mellitus, high blood pressure (BP) [systolic BP> 140 and/or diastolic BP> 90], thyroid disease, tachyarrhythmia, heart disease, kidney disease, or liver disease.
- •Subject currently suffers from a sleep disorder and/or has a known history of (or is currently being treated for) clinical depression, eating disorder(s) or any other psychiatric condition(s), which in the opinion of the investigator, might put the subject at risk and/or confound the results of the study.
- •Subject has a known allergy or sensitivity to any ingredient in the test product.
- •Subject has any medical condition or uses any medication, nutritional product, dietary supplement or program, which in the opinion of the investigator, might interfere with the conduct of the study or place the subject at risk.
- •Subject has a history of orthopaedic injury or surgery within the last year.
- •Subject has any physical condition considered a contraindication to the type of exercise performed in the study.
- •Subject has had an abnormal resting ECG.
- •Investigator is uncertain about subject’s capability or willingness to comply with the protocol requirements.
结局指标
主要结局
Difference in the Creatine Kinase and CRP levels
时间窗: Time Frame: baseline Day 0, week 8
group
时间窗: Time Frame: baseline Day 0, week 8
between the intervention group and the placebo
时间窗: Time Frame: baseline Day 0, week 8
次要结局
- Differences in muscle soreness pain VAS between the intervention group and the placebo group over the study period.(Time Frame: baseline (Day 1, wk 4, wk 8])