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

• Sponsor: Huazhong University of Science and Technology (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03316612
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 11.6
• Patients Per Site Per Month: 6.9

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Nov 10, 2017
• Anticipated Primary Completion Date: Jun 30, 2018
• Anticipated Study Completion Date: Oct 30, 2018

Arms and Interventions

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

Primary Outcome Measures

1. Changes in plasma AGEs levels [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 [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 [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 [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 [At 0 week (baseline), 10th week.]

6. Changes in plasma metabolites [At 0 week (baseline), 4th week, 10th week.]

Secondary Outcome Measures

1. Changes in skin AGEs levels [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 [At 0 week (baseline), 4th week, 10th week.]

3. Change in body composition (body fat mass and lean mass) [At 0 week (baseline), 4th week, 10th week.]

4. Changes in blood lipids profile [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 [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) [At 0 week (baseline), 10th week.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Huazhong University of Science and Technology	Wuhan	Hubei	China	430030

Sponsors and Collaborators

• Huazhong University of Science and Technology

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Liegang Liu, Professor, Huazhong University of Science and Technology
• ClinicalTrials.gov Identifier: NCT03316612
• Other Study ID Numbers: C01-201611090005
• First Posted: Oct 20, 2017
• Last Update Posted: Apr 10, 2018
• Last Verified: Apr 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Liegang Liu, Professor, Huazhong University of Science and Technology: Advanced Glycation End Products, Metabolites, Gut Microbiota

Study Results

No Results Posted as of Apr 10, 2018