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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-10

Study Completion Date

2018-10-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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).

Study Groups

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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.

Group Type EXPERIMENTAL

Vaccinium Myrtillus L. extract

Intervention Type DIETARY_SUPPLEMENT

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

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Vaccinium Myrtillus L. extract

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes