Investigation of the Effects of Dietary Lecithin on Intestinal Permeability, Bacterial Translocation, Microbiota and Glucose Metabolism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in bacterial translocation
研究概览
简要总结
This dietary intervention study will assess the effect in healthy human volunteers of an E number which is a food additive and commonly used and consumed emulsifier, on gut function, gut inflammation and glucose metabolism. We will be using a powdered soy lecithin product in the food to compare a diet with and without this ingredient.
详细描述
A dietary intervention study to investigate the effect, in healthy human volunteers, of dietary lecithin (soy lecithin), a commonly used/consumed emulsifier, on markers of gut function particularly bacterial translocation (assessed by measure of venous blood bacterial DNA, circulating lipopolysaccharide [LPS] binding protein and soluble CD14), gut inflammation (assessed by measurement of faecal calprotectin), gut microbiota activity/composition (faecal short-chain fatty acid [SCFA] profile and bacterial diversity [16S ribosomal RNA genes]) and glucose metabolism (measured by oral glucose tolerance test [OGGT], plasma fasted lipids and insulin).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI ranging from 27-40 kg/m2
排除标准
- •Antibiotic use within the past 3 months (due to impact on gut microbiota)
- •Current Statin use
- •Current Aspirin use
- •Chronic inflammatory disorders (including rheumatoid arthritis, inflammatory bowel disease)
- •Food allergies or self-reported food sensitivity or intolerance
- •Diagnosis of diabetes
- •Pregnant or breastfeeding
- •Unsuitable veins for blood sampling
- •Inability to speak, read and understand English
- •Unable to comply to alcohol-free diet for 5 weeks
- •Consumption of nutrition supplements
- •Soy allergy or intolerance.
结局指标
主要结局
Change in bacterial translocation
时间窗: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion
Assessment of change in bacterial translocation by venous blood bacterial DNA measured as responding to pre and post dietary treatment as gene copy number per ml but using more validated universal qPCR primer sets (including total bacteria, phyla- and class-specific primers)
次要结局
- Faecal volatile organics compounds(Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion)
- Faecal short chain fatty acids(Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion)
- Plasma trimethylamine-N-oxide (TMAO)(Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion)
- Faecal calprotectin(Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion)
- Faecal bacterial 16S rRNA gene sequencing(Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion)
- Plasma highly sensitive C-reactive protein(Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion)
- Plasma soluble CD14 and LPS binding protein(Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion)
- Plasma fasting blood glucose and up to 3 hours after OGTT(Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion)
- Plasma fasting lipid profile(Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion)
- Plasma fasted insulin profile and up to 2 hours postprandial OGTT(Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion)