Evaluation of the Effect of Momchilovtsi Yogurt on Intestinal Health and Blood Lipid Adjustment in Human Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- Change from baseline in health status of the intestinal tract at Day 49
研究概览
简要总结
This was a randomized, double-blind, single-center, placebo-controlled, two-arm study. The objectives of this study were to evaluate the effect of Momchilovtsi yogurt on:
- Improving intestinal digestion and bowl movement;
- Adjusting blood total Cholesterol and Triglycerides levels;
- Adjusting microbiological flora (Clostridium perfringens bacteria, Lactobacillus and Bifidobacterium) in gastrointestinal tract;
- Adjusting short chain fatty acids (acetic acid, propionic acid, butyric acid) in in gastrointestinal tract.
详细描述
- Quality control of the study:
1.1 Study monitoring and source data verification:
Monitoring was done according to the monitoring plan by a representative of the investigator, who checked the case report forms for completeness and clarity, and cross-checked them with source documents. In addition to the monitoring visits, frequent communications (letter, telephone, fax, e-mail), by the study monitor ensured that the investigation was conducted according to protocol design and regulatory requirements. Study close-out was performed by the study monitor upon closure of the study.
1.2 On-site audits:
Domestic and foreign regulatory authorities, the Institutional Review Board, and an auditor authorized by the sponsor may request access to all source documents, case report forms, and other study documentation for on-site audit or inspection. Direct access to these documents was guaranteed by the investigator, who must provide support at all times for these activities. Medical records and other study documents may be copied during audit or inspection provided that subject names are obliterated on the copies to ensure confidentiality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged 30-60 years;
- •Abnormal blood lipids level;
- •Have aperiodic or occasional gastrointestinal symptom (gastrointestinal tympanites, abnormal borborygmus, heavy feeling after meal, celiodynia, abdominal pain);
- •Slow power of intestinal tract or irregular intestinal moving (abnormal feces solidity, decreased feces quantity, e.g. defecate every 2-3 days or defecate less than 3 times a week)
排除标准
- •Diagnosed as chronic constipation;
- •Receiving treatment for gastrointestinal symptoms;
- •Lactose Intolerance;
- •In use of analgesic such as aspirin or Panadol, etc;
- •Have had laxatives or other substance that will enhance digestion within 2 weeks before the study begins;
- •Have had dairy products or other food containing probiotics within 10 days before the study begins;
- •Have diarrhea currently;
结局指标
主要结局
Change from baseline in health status of the intestinal tract at Day 49
时间窗: Day 0, 49
Weekly stool frequency (\>6; 4-6; 1-3; 0) Ratio of unopened defecation times vs. total defecation times (0; 1/4; 1/3; ≥1/2) Duration of defecation (\<5 min; 5-15 min; 16-30 min; ≥30 min) Defecation condition (normal perception; straining/uncomfortableness at stool; obvious straining/uncomfortableness or difficulty at stool, little feces quantity; frequent symptom of celialgia or calor at anus, which affect defecation)
次要结局
- Blood total cholesterol level (mmol/L)(Baseline (day 0), day 49)
- Blood triglycerides level (mmol/L)(Baseline (day 0), day 49)
- Fecal bacterium counts(Baseline (day 0), day 49)
- Fecal short chain fatty acids (%)(Baseline (day 0), day 49)
- Score of digestive system (score 0-10)(Day 0, 7, 14, 21, 28, 35, 42, 49)
- Satisfaction with Defecation Habit(Day 0, 7, 14, 21, 28, 35, 42, 49)