Växtbaserade Proteiner påverkan på människors tarmhälsa Dietary Protein Impact on Human Gut Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Changes in the faecal metabolites using targeted and untargeted metabolomics
研究概览
简要总结
The overall aim of this project is to evaluate the quantity of dietary protein that affects gut protein metabolization and if the baseline measurements are stable.
详细描述
Healthy male and female adult subjects (n=39) will be recruited to take part in an evaluation study to determine the amount of dietary protein intake which influences gut-protein-derived metabolites production. The subjects eligible to take part in this study will consume an isolated plant protein for 4 weeks, in each week the amount of protein supplementation will increase. The protein will be provided as a powder in opaque bags and participants will be instructed to dissolve the contained powder in liquids (as water) or on their food (e.g., yogurt, oat porridge). The baseline will consist in 4 visits, which in all visits faecal samples will be collected by themselves at their house or at hospital, using materials provided by the study staff. In one baseline visits (visit 4) in addition to the faecal sample, urinary sample will be collected by themselves, and blood samples will be collected at the hospital. After that, subjects will have the dietary intervention for four weeks and more 4 visits. For the visits with blood collection (visits 4 to 8), subjects will come to the study centre after 10 hours overnight fast. Subjects will have anthropometry measurements taken in the visits 4, 5, 6, and 7 using a Tanita® full body composition. Subjects will respond to questionnaires about their physical activity (once a week), Gastrointestinal Symptom rating scale (GSRS - once a week) and track their intestinal habits using Bristol scale (every day). Subjects' diet will be assessed using a web-based 24-hour diet recall (interviewed so the participants learn how to use the tool regardless of where they are) followed by multiple day records (3 times week).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-45 years
- •Body mass index (BMI) 18,5-30 kg/m2
- •Weight stable within the previous 3 months
- •Maintenance of the usual physical activity habits during the study
- •Intake of fibre between 15 and 25 g per day (evaluated by 3 food diaries or 24-hours recalls)
- •Omnivores
排除标准
- •Acute chronic disease, inflammatory or functional gastrointestinal diseases and any other disease or disorder that could affect the outcome of the study
- •Use of a medication that may interfere the study outcome
- •Eating disorder
- •High protein intake (more than 15% of energy or maximum 1,2 g of protein per kg of body weight per day; evaluated by 3 food diaries or 24-hours recalls)
- •Use of antibiotic medication during the last 3 months prior the first visit
- •Use of antibiotic medication very early in life (e.g., asthmatic children or ear inflammation)
- •Use of laxative or anti-diarrhoea medication within the past 3 months before the study
- •Regular consumption of probiotic or prebiotic product for the past 6 weeks before the study
- •Special diet that is considered to affect the study participation and/or study results, for example, high protein diets
- •More than 5 h of moderate-vigorous exercise per week
- •Pregnancy or breastfeeding
- •Intolerance to dietary supplements that will be used in the study
- •Abuse of alcohol or drugs (according to AUDIT score)
结局指标
主要结局
Changes in the faecal metabolites using targeted and untargeted metabolomics
时间窗: 8 weeks
Difference in faecal metabolites depending on the protein supplementation amount. Targeted and untargeted metabolomics measurements will be used (e.g., short-chain fatty acids and branched chain fatty acids analyses, and polar and non polar metabolomics). Faecal samples will have their metabolites extracted and quantified by liquid chromatography coupled with high-resolution time-of-flight mass spectrometry (UHPLC-qToF-MS), and gas chromatography coupled with high-resolution mass spectroscopy (GC-Orbitrap). The level of metabolites will be compared throughout the whole study.
Routinely analysed markers for protein intake/compliance - urine
时间窗: 5 weeks
Difference in 24 h urine samples markers due to the protein supplementation (e.g., for 24 h urine: urea nitrogen from 24 h urine, creatinine, uric acid)
Routinely analysed markers for protein intake/compliance - blood
时间窗: 5 weeks
Difference in blood (serum) samples markers due to the protein supplementation (e.g., urea and creatinine)
次要结局
- Food intake using food diaries(8 weeks)
- Changes in the gut microbiota profile during the baseline period(4 weeks)
- Changes in the faecal metabolites during the baseline period(4 weeks)
- Assessment of the Gastrointestinal Symptom rating scale (GSRS) during the study(8 weeks)
- Assessment of the bowel movement using the Bristol scale diary(8 weeks)
- Assessment of physical activity level(8 weeks)
- Assessment of body composition(6 weeks)
- Assessment of body weight during the study(6 weeks)
- Profile/composition of the gut microbiota during the intervention(5 weeks)
- Assessment of height(5 weeks)
- Concentrations of faecal calprotectin(5 weeks)
- Concentration of glucose(5 weeks)
- Concentration of insulin(5 weeks)
- Concentration of C-reactive protein(5 weeks)
- Concentration of cholesterol (total, LDL, and HDL)(5 weeks)
- Concentration of triglycerides(5 weeks)