The Effect of Vaccinium Myrtillus L. Extract Intake on Human Metabolism: A Randomized Double-Blind Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Changes in gut microbiota
研究概览
简要总结
Advanced glycation end-products (AGEs) has been linked to ageing, and many metabolic diseases. The findings of previous experiments suggested that the extracts from polyphenol-rich bilberry might inhibit the formation of AGEs. This is a randomized double-blind trial, aims to study the effect of Vaccinium Myrtillus L. natural extracts on AGEs and human metabolism. Firstly, we will investigate the efficacy of Bilberry extracts on lowering the levels of advanced glycation end-products (AGEs). Secondly, we will conduct 16S rRNA sequencing and ultra-high performance liquid chromatography-tandem mass spectrometric (UPLC-MS/MS) detection to explore the role of bilberry extracts on gut microbiota as well as metabolites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The all details of groups assignment are arranged and controlled by the research designers. The color, shape, and external packaging of the bilberry extract and placebo are consistent (brown oval tablets). Each bottle of tablets will be marked with the name (or identify number) of the participants by research designers. Thus, the grouping of participants is blind to the rest of the researchers (like outcomes assessors).
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 18-35 years of age
- •Able to give informed connect
排除标准
- •Pregnancy
- •Known cardiovascular disease (stroke, ischemic heart disease and so on), diabetes, hypertension and any other chronic disease.
- •Known gastrointestinal disease, such as Irritable Bowel Syndrome(IBS), functional bowel disease and so on.
- •Evidence of drug or alcohol abuse
结局指标
主要结局
Changes in gut microbiota
时间窗: At 0 week (baseline), 10th week.
Changes in plasma sRAGE levels
时间窗: At 0 week (baseline), 4th week, 10th week.
sRAGE (soluble Receptor for Advanced Glycation End-products)
Changes in transcription levels of RAGE and AGER1
时间窗: At 0 week (baseline), 4th week, 10th week.
Extract and isolate peripheral blood mononuclear cells (PBMC) from participants. Using the PCR technology to detect the mRNA levels of RAGE and AGER1.
Changes in urinary AGEs levels
时间窗: At 0 week (baseline), 4th week, 10th week.
Using UPLC-MS/MS to detect urinary AGEs (including CML, CEL, MG-H1).
Changes in plasma AGEs levels
时间窗: At 0 week (baseline), 4th week, 10th week.
Using UPLC-MS/MS to detect plasma AGEs (including CML, CEL, MG-H1).
Changes in plasma metabolites
时间窗: At 0 week (baseline), 4th week, 10th week.
次要结局
- Change in body composition (body fat mass and lean mass)(At 0 week (baseline), 4th week, 10th week.)
- Changes in skin AGEs levels(At 0 week (baseline), 4th week, 10th week.)
- Changes in body weight(At 0 week (baseline), 4th week, 10th week.)
- Changes in blood lipids profile(At 0 week (baseline), 4th week, 10th week.)
- Changes in fecal short chain fatty acids (SCFA)(At 0 week (baseline), 10th week.)
- Changes in pro-inflammatory markers(At 0 week (baseline), 4th week, 10th week.)
研究者
Liegang Liu
Professor
Huazhong University of Science and Technology