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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03316612
Recruitment Status : Unknown
Verified April 2018 by Liegang Liu, Huazhong University of Science and Technology.
Recruitment status was:  Recruiting
First Posted : October 20, 2017
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Liegang Liu, Huazhong University of Science and Technology

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Vaccinium Myrtillus L. extract Dietary Supplement: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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).
Primary Purpose: Prevention
Official Title: The Effect of Vaccinium Myrtillus L. Extract Intake on Human Metabolism: A Randomized Double-Blind Trial
Actual Study Start Date : November 10, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : October 30, 2018

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. 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).

  3. Changes in plasma sRAGE levels [ Time Frame: At 0 week (baseline), 4th week, 10th week. ]
    sRAGE (soluble Receptor for Advanced Glycation End-products)

  4. 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.

  5. Changes in gut microbiota [ Time Frame: At 0 week (baseline), 10th week. ]
  6. Changes in plasma metabolites [ Time Frame: At 0 week (baseline), 4th week, 10th week. ]

Secondary Outcome Measures :
  1. Changes in skin AGEs levels [ Time Frame: At 0 week (baseline), 4th week, 10th week. ]
    Using AGE Reader to quickly and noninbasively measure skin AGEs by means of fluorescence techniques.

  2. Changes in body weight [ Time Frame: At 0 week (baseline), 4th week, 10th week. ]
  3. Change in body composition (body fat mass and lean mass) [ Time Frame: At 0 week (baseline), 4th week, 10th week. ]
  4. Changes in blood lipids profile [ Time Frame: At 0 week (baseline), 4th week, 10th week. ]
    Fasting plasma Total cholesterol, Low Density Lipoprotein, High Density Lipoprotein and triglycerides.

  5. Changes in pro-inflammatory markers [ Time Frame: At 0 week (baseline), 4th week, 10th week. ]
    Fasting plasma C-reactive protein, interleukin-6 and tumor necrosis factor-α

  6. Changes in fecal short chain fatty acids (SCFA) [ Time Frame: At 0 week (baseline), 10th week. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03316612


Contacts
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Contact: Liegang Liu, MD, PhD +86-27-83650522 liegangliu@gmail.com

Locations
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China, Hubei
Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430030
Contact: Liegang Liu, MD, PhD    +86-27-83650522    liegangliu@gmail.com   
Principal Investigator: Liangkai Chen, MD         
Principal Investigator: Xiaoli Hu, MD         
Principal Investigator: Qiang Wang, MD         
Sponsors and Collaborators
Huazhong University of Science and Technology
More Information
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Responsible Party: Liegang Liu, Professor, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT03316612    
Other Study ID Numbers: C01-201611090005
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Liegang Liu, Huazhong University of Science and Technology:
Advanced Glycation End Products, Metabolites, Gut Microbiota