Evaluation of Efficacy and Safety of AGP on Immune Enhanc... | NCT03330392

Studies
Evaluation of Efficacy and Safety of AGP on Immune Enhancement

NCT03330392

Sponsor

Chonbuk National University Hospital

Status

Completed

Last Update Posted

Nov 8, 2017Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Immune Function

Interventions

AGP
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2017Actual

Primary Completion Date

Sep 7, 2017Actual

Completion Date

Oct 27, 2017Actual

First Submitted Date

Oct 31, 2017

First Submission Date that Met QC Criteria

Oct 31, 2017

First Posted Date

Nov 6, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2017

Last Update Posted Date

Nov 8, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Soo-Wan Chae, Principal Investigator, Clinical Trial Center for Functional Foods, Chonbuk National University HospitalPrincipal Investigator

Lead Sponsor

Chonbuk National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AGP	Experimental	take two tablets per day (500 mg/day) for 8 weeks.	Dietary Supplement: AGP
Placebo	Placebo Comparator	take two tablets per day for 8 weeks.	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AGP	Dietary Supplement	take two tablets per day (500 mg/day) for 8 weeks	AGP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Natural killer cell activity	Changes of NK cell activity were assessed before and after the intervention.	0 week, 8 week

Secondary Outcomes

Measure	Description	Time Frame
Interleukin-1β	Changes of IL-1β were assessed before and after the intervention.	0 week, 8 week
Interleukin-6	Changes of IL-6 were assessed before and after the intervention.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Trial Center for Functional Foods Chonbuk National University Hospital		Jeonju	Jeollabuk-do	54907	South Korea