the Efficacy and Safety of Blueberry Yeast Fermentation Freeze Dying Powder on Promotion of Immunity

NCT ID: NCT03923894

Last Updated: 2019-08-26

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

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-14

Study Completion Date

2019-05-14

Brief Summary

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This study was conducted to investigated the effects of daily supplementation of Blueberry Yeast Fermentation Freeze Dying Powder on Promotion of Immunity.

Detailed Description

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This study was a 8-week, randomized, double-blind, placebo-controlled human trial. 100 subjects were randomly divided into Blueberry Yeast Fermentation Freeze Dying Powder extract 2.07 g or placebo group. The investigated measured Natural Killer cell activity, Cytokines, Upper respiratory infection questionnaire score, etc.

Conditions

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Immunity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Blueberry Yeast Fermentation Freeze Dying Powder Extract

Blueberry Yeast Fermentation Freeze Dying Powder Extract 2.07 g/day for 8 weeks.

Group Type EXPERIMENTAL

Blueberry Yeast Fermentation Freeze Dying Powder Extract

Intervention Type DIETARY_SUPPLEMENT

Blueberry Yeast Fermentation Freeze Dying Powder Extract 2.07 g/day for 8 weeks.

Placebo

Placebo 2.07 g/day for 8 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo 2.07 g/day for 8 weeks.

Interventions

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Blueberry Yeast Fermentation Freeze Dying Powder Extract

Blueberry Yeast Fermentation Freeze Dying Powder Extract 2.07 g/day for 8 weeks.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo 2.07 g/day for 8 weeks.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Adult men and women over 50 years
* After fully hearing and fully understanding this clinical trials, those who agree to voluntarily decide to participate and to comply with the notice

Exclusion Criteria

* If screening shows that the white blood cell(WBC) is less than 3000/㎕ or more than 8000/㎕
* Those who received influenza vaccination within 3 months before the screening
* Those who have a body mass index(BMI) of less than 18.5 kg / m2 or greater than 35 kg / m2 at the screening
* Those who have a clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry, musculoskeletal system, inflammatory and hematologic
* Those who take a medication or health function food that affects your promotion of immunity within 1 month prior to the screening
* Those who have received antipsychotic medication within 3 months before screening
* Those who alcoholic or drug abuse suspected
* Those who participated in other clinical trials within 3 months before screening
* Laboratory test by show the following results

* Aspartate Transaminase(AST), Alanine Transaminase(ALT) \> Reference range 3 times upper limit
* Serum Creatinine \> 2.0 mg/dL
* Pregnancy or breast feeding
* Those who doesn't accept the implementation of appropriate contraception of a childbearing woman
* Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chonbuk National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Soo-Wan Chae

Principal Investigator, Clinical Trial Center for Functional Foods

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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MIFI-PI-BB

Identifier Type: -

Identifier Source: org_study_id

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