Upper Respiratory Infection
Conditions
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.
Interventions
DIETARY_SUPPLEMENTAllium Cepa L. Peel Heated Water Extract
4 capsules/day after meal(1,200 mg/day) for 8 weeks
DIETARY_SUPPLEMENTPlacebo
4 capsules/day after meal(1,200 mg/day) for 8 weeks
Sponsors
Hanyang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed