Evaluation of Efficacy and Safety of AGP on Immune Enhancement

Immune Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03330392
• Other study ID #: CTCF2_2017_AGP
• Status: Completed
• Phase: N/A
• First received: October 31, 2017
• Last updated: November 7, 2017
• Start date: July 1, 2017
• Est. completion date: October 27, 2017

Study information

• Verified date: November 2017
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 27, 2017
• Est. primary completion date: September 7, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Immune Function

Intervention

Dietary Supplement:
• AGP
take two tablets per day (500 mg/day) for 8 weeks
• Placebo
take two tablets per day (500 mg/day) for 8 weeks

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Center for Functional Foods Chonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Natural killer cell activity	Changes of NK cell activity were assessed before and after the intervention.	0 week, 8 week
Secondary	Interleukin-1ß	Changes of IL-1ß were assessed before and after the intervention.	0 week, 8 week
Secondary	Interleukin-6	Changes of IL-6 were assessed before and after the intervention.	0 week, 8 week
Secondary	Interleukin-12 (IL-12)	Changes of IL-12 were assessed before and after the intervention.	0 week, 8 week
Secondary	Interferon-? (IFN-?)	Changes of IFN-? were assessed before and after the intervention.	0 week, 8 week
Secondary	Tumor necrosis factor-a (TNF-a)	Changes of TNF-a were assessed before and after the intervention.	0 week, 8 week
Secondary	Changes of White blood cell (WBC)	Changes of WBC were assessed before and after the intervention.	0 week, 8 week