UMIN-CTR Clinical Trial

Public title

Effects of the Consumption of Test Foods on Allergic Reactions of the Nose and Eyes Caused by Allergens

Acronym

Effects of the Consumption of Test Foods on Allergic Reactions of the Nose and Eyes Caused by Allergens

Scientific Title

Effects of the Consumption of Test Foods on Allergic Reactions of the Nose and Eyes Caused by Allergens: A Randomized Double-Blind Placebo-Controlled Trial

Scientific Title:Acronym

Effects of the Consumption of Test Foods on Allergic Reactions of the Nose and Eyes Caused by Allergens

Region

Japan

Condition

Healthy Japanese subjects and subjects with mild symptoms

Classification by specialty

Clinical immunology

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The objective of this trial was to investigate the effects of a four-week, continuous consumption of the test food on subjective symptoms related to allergic reactions to allergens in Japanese adult with eye- and nose discomfort.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

The measured values and changes on scores for each category and items of Japanese Rhino-conjunctivitis Quality of Life Questionnaire questionnaire at two and four weeks after the start of test-food consumption

Key secondary outcomes

The measured values and changes of subjective symptom scores based on the severity classification measurements of allergic rhinitis, eosinophils in nasal discharge, non-specific IgE, specific IgE (Dermatophagoides pteronyssinus, Japanese red-cedar, cypress, and house dust 1), and all VAS item scores at two and four weeks after the start of test-food consumption

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: Four weeks
Test food: Tablets containing flavonoids
Administration: Take a total of four tablets per day (two tablets after breakfast and other two tablets after dinner), ingested with water

* If you forget to take the tablets, take tablets as soon as you remember during the day.

Interventions/Control_2

Duration: Four weeks
Test food: Placebo
Administration: Take a total of four tablets per day (two tablets after breakfast and other two tablets after dinner), ingested with water

* If you forget to take the tablets, take tablets as soon as you remember during the day.

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Japanese males and females
2. Subjects with eye and nose discomfort
3. Subjects who are judged as eligible to participate in the trial by the physician
4. Subjects who have relatively high score in the nasal and eye symptoms score of JRQLQ at the point of screening
* Among the healthy subjects and those with mild symptoms, more than half of the enrolled subjects will be selected from healthy subjects.

a. Healthy subjects:
1. Subjects suffering or having suffered from allergic reactions in their eyes and nose
2. Subjects not using antiallergic drugs before and during the trial

b. Subjects with mild symptoms:
1. Subjects suffering or having suffered from allergic reactions in their eyes and nose
2. Subjects who sometimes (not regularly) used ant allergic drugs before and during this trial
* "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

1. Subjects undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction

2. Subjects carrying a pacemaker or an implantable cardioverter defibrillator (ICD)

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

4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage as part of their daily intake

5. Subjects receiving long-term drug treatment (Antiallergic drugs, antihistamines, steroids, vasoconstrictors, antihypertensives, etc.) that may affect allergic symptoms of the nose and eyes during the trial

6. Subjects currently regularly taking medications (including herbal medicines) and supplements

7. Subjects allergic to medications and/or the test-food-related products

8. Subjects who cannot take the test food with the prescribed amount and ingestion method

9. Subjects who are planning to go abroad during this trial

10. Subjects who have a nasal irrigation habit

11. Subjects who are lactating, pregnant, or intending to become pregnant

12. Subjects who have been enrolled in other clinical trials within the last three months before the invitation to participate in this trial, or plan to participate in another trial during this trial

13. Subjects who are judged by the physician as ineligible to participate in the trial

Target sample size

60

Name of lead principal investigator

1st name	Kazuo
Middle name
Last name	YAMAMOTO

Organization

ORTHOMEDICO Inc.

Division name

CEO

Zip code

112-0002

Address

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

TEL

03-3818-0610

Email

kazu@orthomedico.jp

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

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

Indena Japan Co., Ltd.
Indena S.p.A.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan and Italy

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Name of secondary funder(s)

Organization

the ethical committee of the Takara Clinic, Medical Corporation Seishinkai

Address

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

Tel

03-5793-3623

Email

info@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)

Date of disclosure of the study information

2020

Year

07

Month

31

Day

URL releasing protocol

Unpublished

Publication of results

Published

URL related to results and publications

http://www.pieronline.jp/content/article/0386-3603/48110/1945

Number of participants that the trial has enrolled

66

Results

Yamada S, Shirai M, Inaba Y, Takara T. Effects of repeated oral intake of the quercetin-containing supplement on allergic reaction-Randomized, placebo-controlled, double-blind parallel-group study-. Jpn Pharmacol Ther. 2020; 48(11): 1945-1959

Results date posted

2021

Year

05

Month

24

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2020

Year

11

Month

27

Day

Baseline Characteristics

Refer to the paper

Participant flow

Refer to the paper

Adverse events

Refer to the paper

Outcome measures

Refer to the paper

Plan to share IPD

Undecided

IPD sharing Plan description

To require consultation among related companies

Recruitment status

Completed

Date of protocol fixation

2019

Year

11

Month

19

Day

Date of IRB

2019

Year

11

Month

19

Day

Anticipated trial start date

2019

Year

12

Month

03

Day

Last follow-up date

2020

Year

04

Month

04

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2019

Year

12

Month

03

Day

Last modified on

2021

Year

05

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044194