Evaluation of Efficacy and Safety of AGP on Immune Enhancement

An 8 Week, Randomized, Double-blind, Placebo-controlled Clinical Trial of AGP on Immune Enhancing Effects

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

Study Overview

• Status: Completed
• Conditions: Immune Function
• Intervention / Treatment: Dietary supplement: AGP; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of, 54907
      • Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AGP; take two tablets per day (500 mg/day) for 8 weeks.	Dietary supplement: AGP; take two tablets per day (500 mg/day) for 8 weeks
Placebo Comparator: Placebo; take two tablets per day for 8 weeks.	Dietary supplement: Placebo; take two tablets per day (500 mg/day) for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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.	0 week, 8 week
Interleukin-12 (IL-12)	Changes of IL-12 were assessed before and after the intervention.	0 week, 8 week
Interferon-γ (IFN-γ)	Changes of IFN-γ were assessed before and after the intervention.	0 week, 8 week
Tumor necrosis factor-α (TNF-α)	Changes of TNF-α were assessed before and after the intervention.	0 week, 8 week
Changes of White blood cell (WBC)	Changes of WBC were assessed before and after the intervention.	0 week, 8 week

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): September 7, 2017
• Study Completion (Actual): October 27, 2017

Study Registration Dates

• First Submitted: October 31, 2017
• First Submitted That Met QC Criteria: October 31, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): November 8, 2017
• Last Update Submitted That Met QC Criteria: November 7, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CTCF2_2017_AGP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No