Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Efficacy and Safety of AGP on Immune Enhancement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03330392
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : November 8, 2017
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital

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

Condition or disease Intervention/treatment Phase
Immune Function Dietary Supplement: AGP Dietary Supplement: Placebo Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: An 8 Week, Randomized, Double-blind, Placebo-controlled Clinical Trial of AGP on Immune Enhancing Effects
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : September 7, 2017
Actual Study Completion Date : October 27, 2017

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




Primary Outcome Measures :
  1. Natural killer cell activity [ Time Frame: 0 week, 8 week ]
    Changes of NK cell activity were assessed before and after the intervention.


Secondary Outcome Measures :
  1. Interleukin-1β [ Time Frame: 0 week, 8 week ]
    Changes of IL-1β were assessed before and after the intervention.

  2. Interleukin-6 [ Time Frame: 0 week, 8 week ]
    Changes of IL-6 were assessed before and after the intervention.

  3. Interleukin-12 (IL-12) [ Time Frame: 0 week, 8 week ]
    Changes of IL-12 were assessed before and after the intervention.

  4. Interferon-γ (IFN-γ) [ Time Frame: 0 week, 8 week ]
    Changes of IFN-γ were assessed before and after the intervention.

  5. Tumor necrosis factor-α (TNF-α) [ Time Frame: 0 week, 8 week ]
    Changes of TNF-α were assessed before and after the intervention.

  6. Changes of White blood cell (WBC) [ Time Frame: 0 week, 8 week ]
    Changes of WBC were assessed before and after the intervention.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330392


Locations
Layout table for location information
Korea, Republic of
Clinical Trial Center for Functional Foods Chonbuk National University Hospital
Jeonju, Jeollabuk-do, Korea, Republic of, 54907
Sponsors and Collaborators
Chonbuk National University Hospital
Layout table for additonal information
Responsible Party: Soo-Wan Chae, Principal Investigator, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT03330392    
Other Study ID Numbers: CTCF2_2017_AGP
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: November 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No