UMIN-ICDS Clinical Trial

Public title

Study on the effects of consumption of the test food on allergic reaction in healthy Japanese

Acronym

Study on the effects of consumption of the test food on allergic reaction in healthy Japanese

Scientific Title

Effects of consumption of the test food on allergic reaction of eyes and nose in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study

Scientific Title:Acronym

Effects of consumption of the test food on allergic reaction of eyes and nose in healthy Japanese

Region

Japan

Condition

Healthy Japanese

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify the effects of consumption of the test food on allergic reaction of eyes and nose.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1. The measured value of the total score of Japanese Rhino-conjunctivitis Quality of Life Questionnaire (JRQLQ) at 12 weeks after consumption (12w)

Key secondary outcomes

1. The change and percentage change of the total score of JRQLQ at 12w from screening (Scr)

2. The measured values of each score of JRQLQ (nasal and eye symptoms, nose, eyes, the total score of QOL, usual daily activities, outdoor activities, social function, sleep, physical, emotional function) at 12w, and their changes and percentage changes from Scr

3. Individuals whose severity classification of allergic rhinitis improved by one or more scales in period 3*~14* compared to period 1*
* Period 1: For 7 days prior to Scr
Period 3: For 7 days since initial consumption
Period 14: From 77 days after consumption to the day before 12w

4. The measured value, of concentration of acetic acid in the blood at 12w, and the change and percentage change of it from Scr

5. The measured values of each cytokine marker at 12w, and their changes and percentage changes from Scr

6. The measured values of specific immunoglobulin E (IgE) at 12w, and the change and percentage change of it from Scr

7. The measured values of non-specific IgE at 12w, and the change and percentage change of it from Scr

8. The measured value of "I feel my cheeks are itchy" (Visual Analogue Scale; VAS) at 12w, and the change and percentage change of it from Scr

9. Individuals who experienced adverse events

10. Individuals whose values of urinalysis and peripheral blood test are outside the reference range after intervention despite within the reference range at Scr

11. Physical measurements, urinalysis, and peripheral blood test

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Food

Interventions/Control_1

Duration: 12 weeks
Test product: Active food

Interventions/Control_2

Duration: 12 weeks
Test product: Placebo food

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Japanese

2. Men or women

3. Adults

4. Healthy individuals

5. Individuals who have eyes and nose discomfort by pollen at last two years

6. Individuals who do not use antiallergic drugs (except for who sometimes use them for eyes and nose discomfort by pollen)

7. Individuals who meet the inclusion criteria 1~6 and whose specific IgE (Japanese red-cedar, and cypress) are relatively high at Scr

8. Individuals who meet the inclusion criteria 1~7 and whose eyes and nose allergic reaction based on results of the investigation questionnaire in advanced at Scr is worse than other individuals

*Among the healthy individuals and those with mild symptoms, more than half of the enrolled individuals will be selected from healthy individuals.
a. Healthy individuals
who have eyes and nose discomfort by pollen at last two years and do not use antiallergic drugs
b. Individuals with mild symptoms
who have eyes and nose discomfort by pollen at last two years and sometimes (not regularly) use antiallergic drugs
*"Sometimes" means using a drug as needed.
*"Regularly use" means using a drug at fixed intervals even if there are no symptoms.

Key exclusion criteria

Individuals who
1. are receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction

2. have an implanted pacemaker or implantable cardioverter defibrillator

3. are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. consume Foods for Specified Health Uses or Foods with Functional Claims

5. intentionally consume vinegar-based beverages (such as black vinegar, apple vinegar or others) in daily

6. consume functional food/beverage that may affect allergic reaction, such as beta-carotene, methylated catechins, lactic acid bacteria, bifidobacteria, rosmarinic acid, acetic acid bacteria, soy fermented polysaccharides, caffeic acid, luteolin, quercetin, hesperidin, or nobiletin at least four times a week

7. usually drink to excess (average of more than about 20 g/day as pure alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)}

8. are taking or using medications (including herbal medicines) or supplements

9. are receiving long-term drug treatment (antiallergic drugs, antihistamines, steroids, vasoconstrictors, antihypertensives, etc.) that may affect allergic symptoms of the nose and eyes during the study

10. are allergic to medications or foods related to the test product

11. are pregnant, lactating, or planning pregnancy during this study

12. have participated in other clinical studies within 28 days before informed consent, or plan to participate in another study during this study

13. are deemed unsuitable for participation in this study by the principal investigator

Target sample size

60

Name of lead principal investigator

1st name	Tsuyoshi
Middle name
Last name	Takara

Organization

Medical Corporation Seishinkai, Takara Clinic

Division name

Director

Zip code

141-0022

Address

9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan

TEL

03-5793-3623

Email

t-takara@takara-clinic.com

Name of contact person

1st name	Naoko
Middle name
Last name	Suzuki

Organization

ORTHOMEDICO Inc.

Division name

R&D Department

Zip code

112-0002

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan

TEL

03-3818-0610

Homepage URL

Email

nao@orthomedico.jp

Institute

Mizkan Holdings Co. Ltd.

Institute

Department

Personal name

Organization

Mizkan Holdings Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

The ethical committee of the Takara Clinic, Medical Corporation Seishinkai

Address

9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan

Tel

03-5793-3623

Email

IRB@takara-clinic.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

Date of disclosure of the study information

2026

Year

10

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2026

Year

10

Month

21

Day

Date of IRB

2026

Year

10

Month

21

Day

Anticipated trial start date

2026

Year

10

Month

30

Day

Last follow-up date

2027

Year

04

Month

29

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

10

Month

30

Day

Last modified on

2026

Year

10

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072650