Healthy
Conditions
Keywords
Advanced Glycation End Products, Metabolites, Gut Microbiota
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.
Interventions
DIETARY_SUPPLEMENTVaccinium Myrtillus L. extract
Twice a day, 2 tablets each time. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.
DIETARY_SUPPLEMENTPlacebo
Twice a day, 2 tablets each time. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.
Sponsors
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in plasma metabolites | At 0 week (baseline), 4th week, 10th week. | — |
| 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 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 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 gut microbiota | At 0 week (baseline), 10th week. | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | — |
| Change in body composition (body fat mass and lean mass) | 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 pro-inflammatory markers | At 0 week (baseline), 4th week, 10th week. | Fasting plasma C-reactive protein, interleukin-6 and tumor necrosis factor-α |
| Changes in fecal short chain fatty acids (SCFA) | At 0 week (baseline), 10th week. | — |
Countries
China
Contacts
Primary ContactLiegang Liu, MD, PhD
Outcome results
None listed