The Effect of Vaccinium Myrtillus L. Extract Intake on Human Metabolism

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Vaccinium Myrtillus L. Extract Intake on Human Metabolism: A Randomized Double-Blind Trial

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Vaccinium Myrtillus L. extract
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 18-35 years of age Able to give informed connect Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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. | Dietary Supplement: Vaccinium Myrtillus L. extract<br>* Twice a day, 2 tablets each time. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.<br>|
| Placebo Comparator: Placebo group<br>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. | Dietary Supplement: Placebo<br>* Twice a day, 2 tablets each time. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in plasma AGEs levels | Using UPLC-MS/MS to detect plasma AGEs (including CML, CEL, MG-H1). | At 0 week (baseline), 4th week, 10th week. | 
| Changes in urinary AGEs levels | Using UPLC-MS/MS to detect urinary AGEs (including CML, CEL, MG-H1). | At 0 week (baseline), 4th week, 10th week. | 
| Changes in plasma sRAGE levels | sRAGE (soluble Receptor for Advanced Glycation End-products) | At 0 week (baseline), 4th week, 10th week. | 
| Changes in transcription levels of RAGE and AGER1 | Extract and isolate peripheral blood mononuclear cells (PBMC) from participants. Using the PCR technology to detect the mRNA levels of RAGE and AGER1. | At 0 week (baseline), 4th week, 10th week. | 
| Changes in gut microbiota |  | At 0 week (baseline), 10th week. | 
| Changes in plasma metabolites |  | At 0 week (baseline), 4th week, 10th week. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in skin AGEs levels | Using AGE Reader to quickly and noninbasively measure skin AGEs by means of fluorescence techniques. | At 0 week (baseline), 4th week, 10th week. | 
| Changes in body weight |  | At 0 week (baseline), 4th week, 10th week. | 
| Change in body composition (body fat mass and lean mass) |  | At 0 week (baseline), 4th week, 10th week. | 
| Changes in blood lipids profile | Fasting plasma Total cholesterol, Low Density Lipoprotein, High Density Lipoprotein and triglycerides. | At 0 week (baseline), 4th week, 10th week. | 
| Changes in pro-inflammatory markers | Fasting plasma C-reactive protein, interleukin-6 and tumor necrosis factor-α | At 0 week (baseline), 4th week, 10th week. | 
| Changes in fecal short chain fatty acids (SCFA) |  | At 0 week (baseline), 10th week. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced Glycation End Products, Metabolites, Gut Microbiota