The Effect of Vaccinium Myrtillus L. Extract Intake on Human Metabolism: A Randomized Double-Blind Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Changes in gut microbiota
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, 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 Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Intervention group
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.
Intervention: Vaccinium Myrtillus L. extract (Dietary Supplement)
Placebo group
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.
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Changes in gut microbiota
Time Frame: At 0 week (baseline), 10th week.
Changes in plasma sRAGE levels
Time Frame: At 0 week (baseline), 4th week, 10th week.
sRAGE (soluble Receptor for Advanced Glycation End-products)
Changes in transcription levels of RAGE and AGER1
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: At 0 week (baseline), 4th week, 10th week.
Secondary Outcomes
- 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.)
Investigators
Liegang Liu
Professor
Huazhong University of Science and Technology