The Effect of Functional Dairy Products Enriched With Dietary Fibers on Human Health and Gut Microbiota
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Evaluation of blood lipid profile
研究概览
简要总结
The purpose of this dietary intervention is to study the effects of dietary fibers on the gut microbiota and use yoghurt as the carrier.
Hypothesis 1: Intake of dietary fibers improves the blood lipid profile of the participants.
Hypothesis 2: Intake of dietary fibers stabilizes the gut microbiome (e.g., low diversity) of the participants, improves gut health and normalizes gastrointestinal function and bowel habits.
详细描述
The study design is a parallel randomized, prospective, pre-post intervention trial. The main goal of this study is to investigate the effect of the dietary fibers in an unsweetened yoghurt. Fermented dairy products have naturally a very low dietary fiber content, but such products can be supplemented with variety of dietary fibers and promote the growth of beneficial gut bacteria. Also, as fermented milk products contain live bacteria, it is possible that prebiotic fibers could support the growth of the starter-culture based strains in the human gut.
PRE-STUDY EVALUATION AND TESTING
- Complete pre-study questionnaire
- Complete orientation to the study and provide voluntary consent to join the study
- Collection of coded intervention products, sampling supplies, and instructional materials 0-WEEK QUESTIONNAIRE AND LABORATORY VISIT
1. Record food intake and gastrointestinal function for 3 days 2. Collect health data and provide a 3-day food frequency questionnaire 3. Provide a stool and blood sample at the laboratory 2-WEEK QUESTIONNAIRE AND LABORATORY VISIT
- Record food intake and gastrointestinal symptoms for 3 days
- Collect health data and provide a 3-day food frequency questionnaire
- Provide a stool and blood sample at the laboratory BLOOD SAMPLE ANALYSES
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 25-55
- •Normal bowel function
- •Regular consumer of dairy products, willing to consume dairy products daily for 2 weeks
- •Ability to provide a signed written informed consent
- •Willing to provide stool and blood specimens 2 times over the 2-week study period
排除标准
- •Diagnosed history of chronic diseases including coronary heart disease, stroke, cancer, type 1 or 2 diabetes mellitus, inflammatory bowel disease, gastritis, autoimmune disease, or rheumatoid arthritis
- •Medication: statins, blood pressure medications, antidepressants, other prescription medications
- •History of bariatric operation, removal of the gallbladder.
- •Food allergies, lactose intolerance
- •Recent (previous 3 months) use of antibiotics
- •Intake of highly dosed pre- or probiotics 2 weeks prior and during the study
- •Current pregnancy or breastfeeding
- •Volunteers showing previously unrecognized illness will also be excluded
- •Individual unable to give informed consent
结局指标
主要结局
Evaluation of blood lipid profile
时间窗: 14 days
Triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol pre- and post-dietary intervention in plasma (mmol/L).
Evaluation of the intestinal microbiota
时间窗: 14 days
Fecal microbiota analysis based on the 16S rRNA sequencing pre- and post-dietary intervention.
Evaluation of blood glucose levels
时间窗: 14 days
Fasting glucose pre- and post-dietary intervention in plasma (mmol/L).
次要结局
- Evaluation of the defecation timing(14 days)
- Evaluation of the stool form(14 days)
- Evaluation of the blood vitamin D status(14 days)
- Evaluation of the defecation frequency(14 days)
- Evaluation of the gastrointestinal symptoms(14 days)
研究者
Madis Jaagura
Project Manager
Center of Food and Fermentation Technologies