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

Upper Respiratory Infection Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05666752
• Other study ID #: NAS-IE-ON
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 7, 2022
• Est. completion date: September 2023

Study information

• Verified date: December 2022
• Source: Hanyang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Tract Infections
• Upper Respiratory Infection

Intervention

Dietary Supplement:
• Allium Cepa L. Peel Heated Water Extract
4 capsules/day after meal(1,200 mg/day) for 8 weeks
• Placebo
4 capsules/day after meal(1,200 mg/day) for 8 weeks

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanyang University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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