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

NCT03316612 | Unknown

• 1 other identifier: C01-201611090005
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Advanced Glycation End Products, Metabolites, Gut Microbiota

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• 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.

• 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.

• Changes in pro-inflammatory markers

  At 0 week (baseline), 4th week, 10th week.

Study Arms (2)

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.

Dietary Supplement: Vaccinium Myrtillus L. extract

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.

Dietary Supplement: Placebo

Interventions

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.

Intervention group

Placebo DIETARY_SUPPLEMENT

Twice a day, 2 tablets each time. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.

Placebo group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 18-35 years of age
• Able to give informed connect

You may not qualify if:

• 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

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Central Study Contacts

Liegang Liu, MD, PhD

CONTACT

+86-27-83650522; liegangliu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: October 20, 2017
• Study Start: November 10, 2017
• Primary Completion: June 30, 2018
• Study Completion: October 30, 2018
• Last Updated: April 10, 2018

Record last verified: 2018-04

Locations

CN (1)