FOod Additives on the Mucosal Barrier
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Intestinal inflammation
研究概览
简要总结
This is a 6-week pilot study in 60 healthy volunteers to explore (1) the effect of an emulsifier-free diet (2) the effect of three dietary emulsifiers which are believed to detrimentally affect human health, (3) and the effect of two neutral alternatives (native rice starch and soy lecithin), compared to placebo on intestinal permeability and inflammation, systemic inflammation, and the gut microbiota.
详细描述
This is a 6-week randomized, double-blind placebo-controlled pilot study in 60 healthy volunteers to explore (1) the effect of an emulsifier-free diet (2) the effect of dietary emulsifiers carrageenan, CMC, and Polysorbate-80 (which are believed to detrimentally affect human health), (3) and the effect of neutral alternatives (native rice starch and soy lecithin) on intestinal permeability and inflammation, systemic inflammation, and the gut microbiota.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The group assignment was only known by the principal investigator. All other people involved (participants and investigators) were blinded.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults
- •a BMI between 18.5 - 30 kg/m2
- •absence of an eating disorder were required.
排除标准
- •pregnancy and lactation
- •presence of a chronic disease or any known condition resulting in immunosuppression
- •past medical history of any eating disorder
- •irritable bowel syndrome
- •celiac disease
- •IBD or any other chronic intestinal disorders
- •prior abdominal surgery other than appendectomy or cholecystectomy
- •family history of IBD
- •current use of non-steroidal anti-inflammatory drugs (NSAIDs), laxatives, anti-diarrheal medication, anticholinergic medications, narcotics, antacids, proton pump inhibitors (PPIs), or dietary supplements that could not be stopped four weeks before the start of the trial
- •antibiotic, prebiotic or probiotic use in the past three months before enrollment
- •presence of food allergies or intolerance to the components of the study diet
- •experienced diarrhoea withing the two weeks prior to screening.
结局指标
主要结局
Intestinal inflammation
时间窗: Baseline - after the emulsifier-free diet (week 2) - after 2 weeks of the supplementation and the emulsifier-free diet (week 4) - at the end of the trial (week 6)
Faecal calprotectin measurement using stool samples (in mg/kg)
Intestinal paracellular permeability measurements
时间窗: Baseline - after the emulsifier-free diet (week 2) - at the end of the trial (week 6)
Intestinal permeability measurements using the lactulose mannitol urinary excretion ratio (LMR) using urine samples
Metabolic health - insulin resistance
时间窗: Baseline - after the emulsifier-free diet (week 2) - after 2 weeks of the supplementation and the emulsifier-free diet (week 4) - at the end of the trial (week 6)
Insulin measurement using blood samples
Intestinal transcellular permeability measurements
时间窗: Baseline - after the emulsifier-free diet (week 2) - - at the end of the trial (week 6)
Intestinal transcellular permeability measurements using LPS (lipopolysaccharide)-binding protein (LBP) measurement using blood samples.
Gut microbiome composition
时间窗: Baseline - after the emulsifier-free diet (week 2) - after 2 weeks of the supplementation and the emulsifier-free diet (week 4) - at the end of the trial (week 6)
Assessment of the gut microbial composition using 16S rRNA sequencing of stool samples.
Gut microbiome metabolism
时间窗: Baseline - after the emulsifier-free diet (week 2) - after 2 weeks of the supplementation and the emulsifier-free diet (week 4) - at the end of the trial (week 6)
Assessment of the gut microbial metabolism faecal short chain fatty acid (SCFA) measurements from stool samples, including acetic acid, propionic acid, and butyric acid.
Systemic inflammation - inflammatory markers
时间窗: Baseline - after the emulsifier-free diet (week 2) - after 2 weeks of the supplementation and the emulsifier-free diet (week 4) - at the end of the trial (week 6)
OLINK inflammatory proteomic panel using blood samples
Systemic inflammation - CRP
时间窗: Baseline - after the emulsifier-free diet (week 2) - after 2 weeks of the supplementation and the emulsifier-free diet (week 4) - at the end of the trial (week 6)
C-reactive protein measurement using blood samples
Metabolic health - lipid profile
时间窗: Baseline - after the emulsifier-free diet (week 2) - after 2 weeks of the supplementation and the emulsifier-free diet (week 4) - at the end of the trial (week 6)
lipid measurements (including LDL-cholesterol, HDL-cholesterol, total cholesterol and triglycerides) using blood samples
Metabolic health - fasting glucose
时间窗: Baseline - after the emulsifier-free diet (week 2) - after 2 weeks of the supplementation and the emulsifier-free diet (week 4) - at the end of the trial (week 6)
Fasting glucose measurements using blood samples
Metabolic health - cardiometabolic markers
时间窗: Baseline - after the emulsifier-free diet (week 2) - after 2 weeks of the supplementation and the emulsifier-free diet (week 4) - at the end of the trial (week 6)
OLINK cardiometabolic proteomic panel using blood samples
Body composition analysis
时间窗: Baseline - after the emulsifier-free diet (week 2) - after 2 weeks of the supplementation and the emulsifier-free diet (week 4) - at the end of the trial (week 6)
bioelectrical impedance analysis (BIA)
次要结局
未报告次要终点