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

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

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 Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Vaccinium Myrtillus L. extract; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Huazhong University of Science and Technology
      • Contact: Liegang Liu, MD, PhD; Phone Number: +86-27-83650522; Email: liegangliu@gmail.com
      • Principal Investigator: Liangkai Chen, MD
      • Principal Investigator: Xiaoli Hu, MD
      • Principal Investigator: Qiang Wang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Vaccinium Myrtillus L. extract; Twice a day, 2 tablets each time. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.
Placebo Comparator: 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.	Dietary supplement: Placebo; Twice a day, 2 tablets each time. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2017
• Primary Completion (Anticipated): June 30, 2018
• Study Completion (Anticipated): October 30, 2018

Study Registration Dates

• First Submitted: October 17, 2017
• First Submitted That Met QC Criteria: October 17, 2017
• First Posted (Actual): October 20, 2017

Study Record Updates

• Last Update Posted (Actual): April 10, 2018
• Last Update Submitted That Met QC Criteria: April 6, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Advanced Glycation End Products, Metabolites, Gut Microbiota
• Other Study ID Numbers: C01-201611090005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No