UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061081 |
|---|---|
| Receipt number | R000069723 |
| Scientific Title | Investigation of the effects of food intake on allergic symptoms |
| Date of disclosure of the study information | 2026/03/27 |
| Last modified on | 2026/03/27 13:59:23 |
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Basic information
Public title
Investigation of the effects of food intake on allergic symptoms
Acronym
Investigation of the effects of food intake on allergic symptoms
Scientific Title
Investigation of the effects of food intake on allergic symptoms
Scientific Title:Acronym
Investigation of the effects of food intake on allergic symptoms
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of food intake on allergic symptoms through a single-arm, open-label study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese Rhinoconjunctivitis Quality of Life Questionnaire (JRQLQ No. 1)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
8-week intake of the test food . Take 2 tablets with water or lukewarm water once a day at breakfast
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Japanese healthy male and female adults aged 20 years or older and under 65 years at the time of informed consent.
(2) Individuals who have owned dogs or cats for at least 1 year.
(3) Individuals who perceive themselves to have allergic symptoms likely caused by dogs or cats.
(4) Individuals who fully understand the purpose and content of the study and agree to participate of their own free will.
Key exclusion criteria
(1) Individuals who regularly use medicines or quasi-drugs related to allergies.
(2) Individuals at risk of developing allergies related to the study or the study food.
(3) Individuals with nasal diseases (nasal polyps, hypertrophic rhinitis, acute or chronic rhinitis, deviated nasal septum, sinusitis, perennial rhinitis) to an extent that interferes with the evaluation of efficacy.
(4) Individuals with diseases requiring constant medication (external or internal), individuals under treatment for diseases (excluding dry eye and dental caries treatment), or individuals with a history of serious diseases requiring medication.
(5) Individuals with irregular lifestyle rhythms, such as shift work or late-night work.
(6) Heavy drinkers.
(7) Smokers.
(8) Individuals with a history of abnormal clinical laboratory values or cardiopulmonary function, or a history of diseases or surgeries that may cause diabetes, glucose metabolism disorders, or lipid metabolism disorders, such as pancreatic disease, endocrine disease (including thyroid-related diseases), liver disease, or gastrectomy, and who are judged to have problems participating in the study.
(9) Individuals who have participated in other clinical studies or trials within 1 month prior to the date of informed consent. (10) Individuals who expect significant changes in their living environment during the study period (travel or business trips of 1 week or more, relocation, transfer, etc.).
(11) Individuals with extremely irregular eating habits.
(12) Individuals judged inappropriate as study subjects by the principal investigator based on background information, pre-test results, or other reasons.
(13) Individuals who are pregnant or may be pregnant, breastfeeding, or wish to become pregnant during the study period.
(14) Others judged inappropriate as study subjects by the principal investigator.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Yukihiko |
| Middle name | |
| Last name | Ito |
Organization
Nissin Foods Holdings Co., Ltd
Division name
Global Innovation Center
Zip code
192-0001
Address
2100 Tobuki-machi, Hachioji-shi, Tokyo 192-0001, Japan
TEL
090-9154-4573
yukihiko.ito@nissin.com
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Kobayashi |
Organization
Macromill, Inc.
Division name
Clinical Trial Department, Life Science Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo 108-0075, Japan
TEL
03-6716-0700
Homepage URL
umin@macromill.com
Sponsor or person
Institute
Macromill, Inc.
Institute
Department
Personal name
Funding Source
Organization
Nissin Foods Holdings Co., Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Kobuna Orthopedic Clinic, Medical Corporation Kohukai
Address
311-2 Gokan-machi, Maebashi-shi, Gunma 371-0813, Japan
Tel
027-212-5608
sagawa@mc-connect.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 27 | Day |
Last modified on
| 2026 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069723
