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Completed

NCT Number: NCT03330392

Evaluation of Efficacy and Safety of AGP on Immune Enhancement

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

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Key information

Conditions

Immune Function

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AGP

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  1. Natural killer cell activity

    Time frame: 0 week, 8 week

    Changes of NK cell activity were assessed before and after the intervention.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 6, 2017
Registry last updated
Nov 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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