Evaluation of Efficacy and Safety of AGP on Immune Enhancement

NCT ID: NCT03330392

Last Updated: 2017-11-08

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2017-10-27

Brief Summary

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The researchers investigated the immune enhancing effects of AGP for Korean participants.

Detailed Description

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The aim of the study is to investigate the effects of AGP on immune enhancement based on 8 week, randomized, double-blind, placebo-controlled clinical trial.

Conditions

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Immune Function

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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AGP

take two tablets per day (500 mg/day) for 8 weeks.

Group Type EXPERIMENTAL

AGP

Intervention Type DIETARY_SUPPLEMENT

take two tablets per day (500 mg/day) for 8 weeks

Placebo

take two tablets per day for 8 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

take two tablets per day (500 mg/day) for 8 weeks

Interventions

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AGP

take two tablets per day (500 mg/day) for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

take two tablets per day (500 mg/day) for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* The levels of white blood cells within range 3x10\^3/μL\~8x10\^3/μL
* have had at least two cold in the last 12 months.

Exclusion Criteria

* subjects with BMI\<18.5 kg/m\^2
* subjects taking medications such as immune related drug or functional foods
* history of disease that could interfere with the test products or impede their absorption
* pregnant or lactating women and heavy smokers.
* being judged by the responsible physician of the local study center as unfit to participate in the study
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 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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CTCF2_2017_AGP

Identifier Type: -

Identifier Source: org_study_id