The Effect of Vaccinium Myrtillus L. Extract Intake on Human Metabolism
- Conditions
- Healthy
- Interventions
- Dietary Supplement: Vaccinium Myrtillus L. extractDietary Supplement: Placebo
- Registration Number
- NCT03316612
- Lead Sponsor
- Huazhong University of Science and Technology
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- Aged between 18-35 years of age
- Able to give informed connect
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Vaccinium Myrtillus L. extract Ingredients: Vaccinium Myrtillus L. extracts, and excipients (cellulose microcrystalline, mannitol, silica, magnesium stearate, coating agent) Brown oval tablet, 650mg per tablet with 150mg Vaccinium Myrtillus L. extracts, twice a day, 2 tablets each time. The intervention period is about 3 months. Placebo group Placebo Ingredients: excipients (cellulose microcrystalline, mannitol, silica, magnesium stearate, coating agent) Brown oval tablet without Vaccinium Myrtillus L. extracts, 650mg per tablet, twice a day, 2 tablets each time. The intervention period is about 3 months.
- Primary Outcome Measures
Name Time Method Changes in gut microbiota At 0 week (baseline), 10th week. Changes in plasma sRAGE levels At 0 week (baseline), 4th week, 10th week. sRAGE (soluble Receptor for Advanced Glycation End-products)
Changes in transcription levels of RAGE and AGER1 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 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 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 At 0 week (baseline), 4th week, 10th week.
- Secondary Outcome Measures
Name Time Method 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. Using AGE Reader to quickly and noninbasively measure skin AGEs by means of fluorescence techniques.
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. Fasting plasma Total cholesterol, Low Density Lipoprotein, High Density Lipoprotein and triglycerides.
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. Fasting plasma C-reactive protein, interleukin-6 and tumor necrosis factor-α
Trial Locations
- Locations (1)
Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China