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

NCT ID: NCT05666752

Last Updated: 2022-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-07

Study Completion Date

2023-09-30

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.

Conditions

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Upper Respiratory Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Allium Cepa L. Peel Heated Water Extract

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

Group Type EXPERIMENTAL

Allium Cepa L. Peel Heated Water Extract

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Allium Cepa L. Peel Heated Water Extract

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hanyang University

OTHER

Sponsor Role lead

Responsible Party

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Yongsoon Park

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yongsoon Park, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Hanyang University

Locations

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Hanyang University

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 38352207 (View on PubMed)

Other Identifiers

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NAS-IE-ON

Identifier Type: -

Identifier Source: org_study_id