Upper Respiratory InfectionNCT05666752
Effect of Intake of Allium Cepa L. Peel Heated Water Extract on Immunity Enhancement
A study testing Allium Cepa L. Peel Heated Water Extract in people with Upper Respiratory Infection, run by Hanyang University at 1 site in South Korea.
Trial summary
This study was conducted to investigate the effects of daily supplementation of Allium Cepa L. Peel Heated Water Extract on Immunity Enhancement Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Infection
- What is being tested?
- Allium Cepa L. Peel Heated Water Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Nov 2022to Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 19-75 years
- Symptoms of upper respiratory infection at least once within past 12 months
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
This study was conducted to investigate the effects of daily supplementation of Allium Cepa L. Peel Heated Water Extract on Immunity Enhancement
Read the 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.
- Conditions
- Upper Respiratory Infection
- Being tested
- Allium Cepa L. Peel Heated Water Extract, Placebo
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allium Cepa L. Peel Heated Water ExtractDietary supplement
4 capsules/day after meal(1,200 mg/day) for 8 weeks
PlaceboDietary supplement
4 capsules/day after meal(1,200 mg/day) for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Allium Cepa L. Peel Heated Water Extract | Experimental | 4 capsules/day after meal(1,200 mg/day) for 8 weeks Receives: Dietary Supplement: Allium Cepa L. Peel Heated Water Extract |
| Placebo | Placebo comparator | 4 capsules/day after meal(1,200 mg/day) for 8 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
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
Measured: At week 0 and week 4 and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start7 Nov 2022
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Respiratory InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanyang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongsoon Park, Hanyang University
- Investigators
- Yongsoon Park, Ph.D., Principal investigator, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666752
- Sponsor's protocol ID
- NAS-IE-ON
- Status last verified
- Dec 2022
- First submitted
- 13 Dec 2022
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38352207
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05666752
- Acronym / sponsor ID
- NAS-IE-ON
- Conditions
- Upper Respiratory Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hanyang UniversityUniversity, hospital or other
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 28 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allium Cepa L. Peel Heated Water Extract | Experimental | Dietary Supplement: Allium Cepa L. Peel Heated Water Extract4 capsules/day after meal(1,200 mg/day) for 8 weeks |
| Placebo | Placebo comparator | Dietary Supplement: Placebo4 capsules/day after meal(1,200 mg/day) for 8 weeks |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 19-75 years
- Symptoms of upper respiratory infection at least once within past 12 months
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allium Cepa L. Peel Heated Water Extract4 capsules/day after meal(1,200 mg/day) for 8 weeks | Dietary supplement | Allium Cepa L. Peel Heated Water Extract |
| Placebo4 capsules/day after meal(1,200 mg/day) for 8 weeks | Dietary supplement | Placebo |
Primary outcome
Changes of Natural killer(NK) cell activity
Time frame: 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.
2 secondary outcomes
Changes of Cytokines(INF-gamma, Interleukin(IL)-2, IL-6, IL-12, Tumor Necrosis Factor(TNF)-alpha, and IL-1beta)
Time frame: At week 0 and week 8
Changes of Wisconsin Upper Respiratory Symptom Survey-21
Time frame: At week 0 and week 4 and week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- Derived from this study: PubMed 38352207Cho 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yongsoon Park, Ph.D. principal investigator
Hanyang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allium Cepa L. Peel Heated Water Extract in people with Upper Respiratory Infection, run by Hanyang University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Natural killer(NK) cell activity (time frame: At week 0 and week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05666752, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2022.