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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | 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. |
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| Placebo group | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaccinium Myrtillus L. extract | Dietary Supplement | Twice a day, 2 tablets each time. Do not take any other medicine, traditional Chinese medicine, or dietary supplements. |
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| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liegang Liu, MD, PhD | Contact | +86-27-83650522 | liegangliu@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430030 | China |
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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).
| Placebo | Dietary Supplement | Twice a day, 2 tablets each time. Do not take any other medicine, traditional Chinese medicine, or dietary supplements. |
|
| 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. |