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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03316612
• Other study ID #: C01-201611090005
• Status: Recruiting
• Phase: N/A
• First received: October 17, 2017
• Last updated: April 6, 2018
• Start date: November 10, 2017
• Est. completion date: October 30, 2018

Study information

• Verified date: April 2018
• Source: Huazhong University of Science and Technology
• Contact: Liegang Liu, MD, PhD
• Phone: +86-27-83650522
• Email: liegangliu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
China	Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	Changes in plasma sRAGE levels	sRAGE (soluble Receptor for Advanced Glycation End-products)	At 0 week (baseline), 4th week, 10th week.
Primary	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.
Primary	Changes in gut microbiota		At 0 week (baseline), 10th week.
Primary	Changes in plasma metabolites		At 0 week (baseline), 4th week, 10th week.
Secondary	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.
Secondary	Changes in body weight		At 0 week (baseline), 4th week, 10th week.
Secondary	Change in body composition (body fat mass and lean mass)		At 0 week (baseline), 4th week, 10th week.
Secondary	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.
Secondary	Changes in pro-inflammatory markers	Fasting plasma C-reactive protein, interleukin-6 and tumor necrosis factor-a	At 0 week (baseline), 4th week, 10th week.
Secondary	Changes in fecal short chain fatty acids (SCFA)		At 0 week (baseline), 10th week.