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

H

Huazhong University of Science and Technology

Status

Unknown

Conditions

Healthy

Treatments

Dietary Supplement: Placebo
Dietary Supplement: Vaccinium Myrtillus L. extract

Study type

Interventional

Funder types

Other

Identifiers

NCT03316612
C01-201611090005

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

80 participants in 2 patient groups, including a placebo group

Intervention group
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Vaccinium Myrtillus L. extract
Placebo group
Placebo Comparator group
Description:
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.
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Central trial contact

Liegang Liu, MD, PhD

Data sourced from clinicaltrials.gov

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