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

Hanyang University80 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Upper Respiratory Infection

Interventions

Allium Cepa L. Peel Heated Water ExtractDIETARY_SUPPLEMENT

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

PlaceboDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 19 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hanyang University

Seoul, South Korea

Outcomes

Primary Outcomes

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.

Time frame: At week 0 and week 8

Secondary Outcomes

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.

Time frame: 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

Time frame: At week 0 and week 4 and week 8

Data from ClinicalTrials.gov

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