NCT03330392

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2017

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 31, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
Last Updated

November 8, 2017

Status Verified

November 1, 2017

Enrollment Period

2 months

First QC Date

October 31, 2017

Last Update Submit

November 7, 2017

Conditions

Immune Function

Outcome Measures

Primary Outcomes (1)

  • Natural killer cell activity

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

    0 week, 8 week

Secondary Outcomes (6)

  • Interleukin-1β

    0 week, 8 week

  • Interleukin-6

    0 week, 8 week

  • Interleukin-12 (IL-12)

    0 week, 8 week

  • Interferon-γ (IFN-γ)

    0 week, 8 week

  • Tumor necrosis factor-α (TNF-α)

    0 week, 8 week

  • +1 more secondary outcomes

Study Arms (2)

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

AGPDIETARY_SUPPLEMENT

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

AGP
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Trial Center for Functional Foods

Study Record Dates

First Submitted

October 31, 2017

First Posted

November 6, 2017

Study Start

July 1, 2017

Primary Completion

September 7, 2017

Study Completion

October 27, 2017

Last Updated

November 8, 2017

Record last verified: 2017-11

Locations

KR(1)