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

Sponsor

Hanyang University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05666752

Collaborator

(none)

Enrollment

Location

Arms

9.8

Anticipated Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study was conducted to investigate the effects of daily supplementation of Allium Cepa

Peel Heated Water Extract on Immunity Enhancement

Condition or Disease	Intervention/Treatment	Phase
Upper Respiratory Infection	Dietary Supplement: Allium Cepa L. Peel Heated Water Extract Dietary Supplement: Placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Nov 7, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Allium Cepa L. Peel Heated Water Extract

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

Dietary Supplement: Allium Cepa L. Peel Heated Water Extract

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

Placebo Comparator: Placebo

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

Dietary Supplement: Placebo

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hanyang University	Seoul		Korea, Republic of	04763

Sponsors and Collaborators

Hanyang University

Investigators

Principal Investigator: Yongsoon Park, Ph.D., Hanyang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yongsoon Park, Professor, Hanyang University

ClinicalTrials.gov Identifier:

NCT05666752

Other Study ID Numbers:

NAS-IE-ON

First Posted:

Dec 28, 2022

Last Update Posted:

Dec 28, 2022

Last Verified:

Dec 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Respiratory Tract Infections

Study Results

No Results Posted as of Dec 28, 2022