UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055991 |
|---|---|
| Receipt number | R000063993 |
| Scientific Title | Verification Study on the Effect of Test Food Intake on Alleviating Eye and Nasal Discomfort. - A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study - |
| Date of disclosure of the study information | 2024/12/02 |
| Last modified on | 2025/05/29 13:23:31 |
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Basic information
Public title
Verification Study on the Effect of Test Food Intake on Alleviating Eye and Nasal Discomfort.
- A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study -
Acronym
Verification Study on the Effect of Test Food Intake on Alleviating Eye and Nasal Discomfort.
- A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study -
Scientific Title
Verification Study on the Effect of Test Food Intake on Alleviating Eye and Nasal Discomfort.
- A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study -
Scientific Title:Acronym
Verification Study on the Effect of Test Food Intake on Alleviating Eye and Nasal Discomfort.
- A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study -
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the impact of continuous intake of the test food for 12 weeks on alleviating eye and nasal discomfort in healthy Japanese men and women aged 20 to 65 years who experience discomfort due to pollen, dust, house dust, etc.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Japanese Allergic Rhinitis QOL Standard Questionnaire (JRQLQ)
Key secondary outcomes
-Severity classification of allergic rhinitis symptoms
-Examining eye and nasal symptoms
-Blood test parameters (hematology, blood biochemistry)
-Urinalysis
-Physical examination (weight, BMI, blood pressure, pulse rate)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Daily intake of 2 packets of the test food for 12 weeks.
Interventions/Control_2
Daily intake of 2 packets of the placebo food for 12 weeks.
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. Age: 20 to 65 years.
2. Gender: Japanese men and women.
3. Individuals experiencing eye or nasal discomfort due to pollen, dust, house dust for the past two years.
4. Positive for specific IgE (Cedar, Hinoki, House dust 1, D. farinae).
5. Not taking allergy medications at the time of consent.
Select more than half of the subjects from the healthy group among healthy and mildly affected individuals.
a) Healthy group: Individuals experiencing eye or nasal allergic reactions due to pollen, dust, house dust for the past two years and not taking allergy medications
b) Mildly affected group: Individuals experiencing eye or nasal allergic reactions due to pollen, dust, house dust for the past two years and occasionally* using (not regularly** taking) allergy medications.
* "Occasionally" refers to use as needed.
** "Regularly" refers to taking medications consistently even when symptoms are absent.
6. Can input electronic diaries via smartphone or PC.
7. Provided written consent after receiving sufficient explanation and fully understanding the study objectives and content.
Key exclusion criteria
1. Individuals with serious cardiovascular diseases (heart failure, myocardial infarction, myocarditis), liver diseases (liver failure symptoms (fulminant hepatitis), liver cirrhosis, liver tumors), kidney diseases (nephrotic syndrome, renal failure (acute and chronic), uremia, hydronephrosis) or any such systemic condition.
2. Individuals with allergies (medications and test food-related foods), especially those allergic totest food.
3. Individuals currently or planning to undergo exercise or dietary therapy under medical supervision.
4. Individuals needing to continue medications that might affect eye and nasal allergy symptoms (anti-allergy drugs, antihistamines, steroids, vasoconstrictors, hypotensives) during the study period.
5. Individuals regularly taking pharmaceutical, specific health foods, or health supplements (e.g., vitamins, lactic acid beverages/supplements aimed at alleviating eye and nasal discomfort).
6. Individuals habitually practicing nasal irrigation.
7. Individuals who do not go out at least once a week.
8. Individuals with extremely irregular eating habits.
9. Individuals who habitually consume excessive alcohol (pure alcohol intake: 40g or more/day).
10. Individuals with irregular lifestyles such as shift work or night work.
11. Individuals planning major changes in lifestyle (diet, sleep, exercise, etc.) during the study period.
12. Individuals planning overseas travel during the study period.
13. Pregnant, lactating women, or those intending to become pregnant during the study period.
14. Individuals who participated in another clinical study within one month before consent, currently participating, or planning to participate during the study period.
15. Any other individuals judged inappropriate for participation by the principal investigator or sub-investigators (e.g., increased risk to the subject due to participation, or potential difficulty in obtaining sufficient data).
Target sample size
82
Research contact person
Name of lead principal investigator
| 1st name | Kyoko |
| Middle name | |
| Last name | Shimazu |
Organization
NIPPN CORPORATION
Division name
Innovation Center, Central Research Laboratory
Zip code
243-0041
Address
5-3-1 Midorigaoka Atsugi-shi Kanagawa Japan
TEL
046-222-6963
k-shimazu@nippn.co.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd
Division name
Planning and Sales Department
Zip code
1040061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
NIPPN CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.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
| 2024 | Year | 12 | Month | 02 | 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
Completed
Date of protocol fixation
| 2024 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 30 | Day |
Last modified on
| 2025 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063993
