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Effect of Intake of Allium Cepa L. Peel Heated Water Extract on Immunity Enhancement

Primary Purpose

Upper Respiratory Infection

Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Allium Cepa L. Peel Heated Water Extract
Placebo
Sponsored by
Hanyang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Upper Respiratory Infection

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age 19-75 years Symptoms of upper respiratory infection at least once within past 12 months Exclusion Criteria: Cardio-cerebrovascular, endocrine, immune, respiratory, musculoskeletal, inflammatory, hematologic, tumorigenic, gastrointestinal diseases, etc. Vaccination within past 2 months BMI < 18.5 kg/m2 or 35 kg/m2 ≤ BMI Immunity enhancement agents within past one months Allergic or hypersensitive to any of the ingredients in the test products Antipsychotic drugs therapy within past 3 months History of alcoholism or drug abuse Participation in any other clinical trials within past 3 months Pregnant or lactating women Judged ineligible to participate in the trial by the principal investigator

Sites / Locations

  • Hanyang University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Allium Cepa L. Peel Heated Water Extract

Placebo

Arm Description

4 capsules/day after meal(1,200 mg/day) for 8 weeks

4 capsules/day after meal(1,200 mg/day) for 8 weeks

Outcomes

Primary Outcome Measures

Changes of Natural killer(NK) cell activity
Changes of Natural killer(NK) cell activity will be assessed before and after the intervention. PBMCs were isolated by density gradient separation, resuspended in phosphate-buffered saline, and determined using trypan blue solution. Natural killer(NK) cell activity was calculated from the results of nonradioactive cytotoxicity assay kits. Effector cells (PBMCs) were seeded in 96-well plates, with 50 ul of target cells (K562), incubated for 4 hours. cytotoxicity was calculated using the following formula: [(experimental-effector spontaneous-target spontaneous)/(target maximum-target spontaneous)]*100.

Secondary Outcome Measures

Changes of Cytokines(INF-gamma, Interleukin(IL)-2, IL-6, IL-12, Tumor Necrosis Factor(TNF)-alpha, and IL-1beta)
Changes of Cytokines(INF-gamma, IL-2, IL-6, IL-12, TNF-alpha, and IL-1beta) will be assessed before and after the intervention. the serum levels of cytokines, including INF-gamma, IL-2, IL-6, IL-12, TNF-alpha, and IL-1beta will be measured.
Changes of Wisconsin Upper Respiratory Symptom Survey-21
Changes of Wisconsin Upper Respiratory Symptom Survey-21 will be assessed before and after the intervention

Full Information

First Posted
December 13, 2022
Last Updated
December 27, 2022
Sponsor
Hanyang University
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1. Study Identification

Unique Protocol Identification Number
NCT05666752
Brief Title
Effect of Intake of Allium Cepa L. Peel Heated Water Extract on Immunity Enhancement
Official Title
A 8 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Allium Cepa L. Peel Heated Water Extract on Immunity Enhancement
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hanyang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study was conducted to investigate the effects of daily supplementation of Allium Cepa L. Peel Heated Water Extract on Immunity Enhancement
Detailed Description
This study was a 8 weeks, randomized, double-blind, placebo-controlled human trial. 40 subjects were randomly divided into Allium Cepa L. Peel Heated Water Extract or a placebo group. Immunity Enhancement profiles before and after the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Allium Cepa L. Peel Heated Water Extract
Arm Type
Experimental
Arm Description
4 capsules/day after meal(1,200 mg/day) for 8 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
4 capsules/day after meal(1,200 mg/day) for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Allium Cepa L. Peel Heated Water Extract
Intervention Description
4 capsules/day after meal(1,200 mg/day) for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
4 capsules/day after meal(1,200 mg/day) for 8 weeks
Primary Outcome Measure Information:
Title
Changes of Natural killer(NK) cell activity
Description
Changes of Natural killer(NK) cell activity will be assessed before and after the intervention. PBMCs were isolated by density gradient separation, resuspended in phosphate-buffered saline, and determined using trypan blue solution. Natural killer(NK) cell activity was calculated from the results of nonradioactive cytotoxicity assay kits. Effector cells (PBMCs) were seeded in 96-well plates, with 50 ul of target cells (K562), incubated for 4 hours. cytotoxicity was calculated using the following formula: [(experimental-effector spontaneous-target spontaneous)/(target maximum-target spontaneous)]*100.
Time Frame
At week 0 and week 8
Secondary Outcome Measure Information:
Title
Changes of Cytokines(INF-gamma, Interleukin(IL)-2, IL-6, IL-12, Tumor Necrosis Factor(TNF)-alpha, and IL-1beta)
Description
Changes of Cytokines(INF-gamma, IL-2, IL-6, IL-12, TNF-alpha, and IL-1beta) will be assessed before and after the intervention. the serum levels of cytokines, including INF-gamma, IL-2, IL-6, IL-12, TNF-alpha, and IL-1beta will be measured.
Time Frame
At week 0 and week 8
Title
Changes of Wisconsin Upper Respiratory Symptom Survey-21
Description
Changes of Wisconsin Upper Respiratory Symptom Survey-21 will be assessed before and after the intervention
Time Frame
At week 0 and week 4 and week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 19-75 years Symptoms of upper respiratory infection at least once within past 12 months Exclusion Criteria: Cardio-cerebrovascular, endocrine, immune, respiratory, musculoskeletal, inflammatory, hematologic, tumorigenic, gastrointestinal diseases, etc. Vaccination within past 2 months BMI < 18.5 kg/m2 or 35 kg/m2 ≤ BMI Immunity enhancement agents within past one months Allergic or hypersensitive to any of the ingredients in the test products Antipsychotic drugs therapy within past 3 months History of alcoholism or drug abuse Participation in any other clinical trials within past 3 months Pregnant or lactating women Judged ineligible to participate in the trial by the principal investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongsoon Park, Ph.D.
Organizational Affiliation
Hanyang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hanyang University
City
Seoul
ZIP/Postal Code
04763
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Effect of Intake of Allium Cepa L. Peel Heated Water Extract on Immunity Enhancement

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