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

Not Applicable

Active, not recruiting

• Conditions: Upper Respiratory Infection
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Allium Cepa L. Peel Heated Water Extract

• Registration Number: NCT05666752
• Lead Sponsor: Hanyang University

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.

Study Timeline

• Study Start: 2022-11-07
• Status Verified: 2022-12
• Study First Submitted: 2022-12-13
• Study First Submitted QC: 2022-12-27
• Last Update Submitted: 2022-12-27
• Study First Posted: 2022-12-28
• Last Update Posted: 2022-12-28
• Primary Completion: 2023-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	4 capsules/day after meal(1,200 mg/day) for 8 weeks
Allium Cepa L. Peel Heated Water Extract	Allium Cepa L. Peel Heated Water Extract	4 capsules/day after meal(1,200 mg/day) for 8 weeks

Primary Outcome Measures

Name	Time	Method
Changes of Natural killer(NK) cell activity	At week 0 and week 8	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

Name	Time	Method
Changes of Cytokines(INF-gamma, Interleukin(IL)-2, IL-6, IL-12, Tumor Necrosis Factor(TNF)-alpha, and IL-1beta)	At week 0 and week 8	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	At week 0 and week 4 and week 8	Changes of Wisconsin Upper Respiratory Symptom Survey-21 will be assessed before and after the intervention

Trial Locations

Locations (1)

Hanyang University; 🇰🇷 Seoul, Korea, Republic of