Intervention of Specific Dietary Fibers on Dynamics of Individual Gut Microbiota
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Evaluation of food consumption data
研究概览
简要总结
The purpose of this dietary intervention is to study the effects of several dietary fibers on the gut microbiota at the personal level. Hypothesis 1: Intake of specific dietary fibers improves the blood lipid profile depending on the personal microbiota of the participants.
Hypothesis 2: detailed food intake analysis and continuous monitoring of gut microbiota enables to draw causative interrelationships between food components, bacteria of gut microbiome and health characteristics.
详细描述
The study design is a cross-over, pre-post intervention trial. All participants are enrolled into all study periods. Study consists of baseline period, four periods of dietary fiber intervention and four periods of wash-outs.
The main goal of this study was to elucidate the patterns between individual dietary fibers and gut microbiota at the personal level. Each person has a unique (individual) intestinal microbiological profile that changes according to lifestyle (diet, environment, physical activity), age and health status. With next generation sequencing methods to map microbial communities and detailed nutritional analysis including blood tests, it is possible to identify the specific effects of specific fiber on a selected (individual) microbiota. TFTAK researchers have long-term experience in microbiota analysis as well as diet design and nutrition analysis, which can be successfully applied in this project.
PRELIMINARY STUDY EVALUATION AND TESTING
- Complete preliminary 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
1-WEEK QUESTIONNAIRE AND LABORATORY VISIT
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 20-60
- •Normal bowel function
- •Omnivorous diet
- •Ability to provide a signed written informed consent
- •Willing to provide stool and blood specimens over the 22-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 food consumption data
时间窗: 150 days
All foods consumed were collected 1 week before the end of every study period using web-based program (tap.nutridata.ee)
Evaluation of the intestinal microbiota
时间窗: 150 days
Fecal microbiota analysis based on the 16S ribosomal RNA (rRNA) sequencing pre- and post-dietary intervention.
Evaluation of blood lipid profile
时间窗: 150 days
Triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol after every intervention and wash-out in plasma (mmol/L).
Evaluation of liver characteristics profile
时间窗: 150
Uric acid, aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), gamma-glutamyltransferase (GGT) after every intervention and wash-out in plasma (mmol/L).
Evaluation of blood glucose levels
时间窗: 150
Fasting glucose pre- and post-dietary intervention in plasma (mmol/L).
次要结局
- Evaluation of the stool form(150 days)
- Evaluation of the gastrointestinal symptoms(150)
- Evaluation of the defecation frequency(150)
研究者
Kaarel Adamberg
Project manager
Center of Food and Fermentation Technologies