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

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

This study was conducted to investigate the effects of daily supplementation of Allium Cepa L. Peel Heated Water Extract on Immunity Enhancement

Study Overview

• Status: Active, not recruiting
• Conditions: Upper Respiratory Infection
• Intervention / Treatment: Dietary supplement: Allium Cepa L. Peel Heated Water Extract; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 04763
    • Hanyang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Allium Cepa L. Peel Heated Water Extract; 4 capsules/day after meal(1,200 mg/day) for 8 weeks	Dietary supplement: Allium Cepa L. Peel Heated Water Extract; 4 capsules/day after meal(1,200 mg/day) for 8 weeks
Placebo Comparator: Placebo; 4 capsules/day after meal(1,200 mg/day) for 8 weeks	Dietary supplement: Placebo; 4 capsules/day after meal(1,200 mg/day) for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At week 0 and week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At week 0 and week 8
Changes of Wisconsin Upper Respiratory Symptom Survey-21	Changes of Wisconsin Upper Respiratory Symptom Survey-21 will be assessed before and after the intervention	At week 0 and week 4 and week 8

Collaborators and Investigators

• Sponsor: Hanyang University
• Investigators: Principal Investigator: Yongsoon Park, Ph.D., Hanyang University

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: December 13, 2022
• First Submitted That Met QC Criteria: December 27, 2022
• First Posted (Estimate): December 28, 2022

Study Record Updates

• Last Update Posted (Estimate): December 28, 2022
• Last Update Submitted That Met QC Criteria: December 27, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiratory Tract Infections
• Other Study ID Numbers: NAS-IE-ON

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No