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

NCT05666752 | Unknown DMC

• 1 other identifier: NAS-IE-ON
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Upper Respiratory Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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 Wisconsin Upper Respiratory Symptom Survey-21

  At week 0 and week 4 and week 8

Study Arms (2)

Allium Cepa L. Peel Heated Water Extract

EXPERIMENTAL

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

Dietary Supplement: Allium Cepa L. Peel Heated Water Extract

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Allium Cepa L. Peel Heated Water Extract DIETARY_SUPPLEMENT

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

Allium Cepa L. Peel Heated Water Extract

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 19-75 years
• Symptoms of upper respiratory infection at least once within past 12 months

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanyang University: lead

Study Sites (1)

Hanyang University

Seoul, 04763, South Korea

Location

Related Publications (1)

• Cho H, Kim S, Lee SH, Park Y. Effect of onion (Allium cepa L.) peel extract on natural killer cell and cytokines in a randomized, double-blind, placebo-controlled trial. Nutr Res Pract. 2024 Feb;18(1):33-45. doi: 10.4162/nrp.2024.18.1.33. Epub 2024 Jan 11.

  PMID: 38352207 DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Yongsoon Park, Ph.D.

  Hanyang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: December 28, 2022
• Study Start: November 7, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: December 28, 2022

Record last verified: 2022-12

Locations

KR (1)