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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Upper Respiratory Infection

Intervention / Treatment
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* Dietary Supplement: Allium Cepa L. Peel Heated Water Extract
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Allium Cepa L. Peel Heated Water Extract<br>4 capsules/day after meal(1,200 mg/day) for 8 weeks | Dietary Supplement: Allium Cepa L. Peel Heated Water Extract<br>* 4 capsules/day after meal(1,200 mg/day) for 8 weeks<br>|
| Placebo Comparator: Placebo<br>4 capsules/day after meal(1,200 mg/day) for 8 weeks | Dietary Supplement: Placebo<br>* 4 capsules/day after meal(1,200 mg/day) for 8 weeks<br>|

What is the study measuring?
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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 |