UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051205 |
|---|---|
| Receipt number | R000058401 |
| Scientific Title | An examination study for evaluating the effects of hearing acuity by consuming the test food: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2023/05/31 |
| Last modified on | 2024/04/19 09:15:51 |
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Basic information
Public title
An examination study for evaluating the effects of hearing acuity by consuming the test food
Acronym
An examination study for evaluating the effects of hearing acuity by consuming the test food
Scientific Title
An examination study for evaluating the effects of hearing acuity by consuming the test food: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
An examination study for evaluating the effects of hearing acuity by consuming the test food
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the improving effects of consumption of the test food on hearing acuity
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Minimum audible threshold at six months after consumption
Key secondary outcomes
1. Minimum audible threshold at two months and four months after consumption
2. Otoacoustic emission levels and the Japanese Version of the Hearing Handicap Inventory for Adults (HHIA) (emotional subscale, social subscale, and each item) at two, four, and six months after consumption
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: Six months
Test food: Capsule containing lactic acid bacteria
Administration: Take one capsule per day with water
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
Interventions/Control_2
Duration: Six months
Test food: Placebo capsule (without lactic acid bacteria)
Administration: Take one capsule per day with water
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next 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
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Subjects aged 40 or more and less than 80
4. Subjects whose right, left, and left/right average of the pure tone average (calculated by one-fourth method) are all 24 dB or less
5. Subjects whose difference in the pure tone average (calculated by one-fourth method) between left and right ear is within 20 dB
6. Subjects whose either value of the distortion product otoacoustic emissions (DPOAE) measured at right, left, or as an average of left and right is -10 dBSPL or more at 500 Hz, 1000 Hz, or 2000 Hz, and whose value measured at right, left, or as an average of left and right is 0 dBSPL or less at 8000 Hz
7. Subjects whose minimum audible threshold of right, left, or left/right average measured at frequency of 8,000 Hz meet any of the following conditions (i~xiv)
i. Men aged 40 to 49: >= 12 dB
ii. Women aged 40 to 49: >= 10 dB
iii. Men aged 50 to 54: >= 19 dB
iv. Women aged 50 to 54: >= 14 dB
v. Men aged 55 to 59: >= 23 dB
vi. Women aged 55 to 59: >= 17 dB
vii. Men aged 60 to 64: >= 30 dB
viii. Women aged 60 to 64: >= 22 dB
ix. Men aged 65 to 69: >= 38 dB
x. Women aged 65 to 69: >= 30 dB
xi. Men aged 70 to 74: >= 44 dB
xii. Women aged 70 to 74: >= 40 dB
xiii. Men aged 75 to 79: >= 53 dB
xiv. Women aged 75 to 79: >= 49 dB
Key exclusion criteria
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, neurological disease, insomnia, sleep disorder, labyrinth disease, or any other chronic diseases
4. Subjects who use or take "Foods for Specified Health Uses," "Foods with Functional Claims," or "Foods with Nutrient Function Claims" in daily
5. Subjects who are currently taking medications (including herbal medicines), internal quasi-drugs, or supplements
6. Subjects who drink to excess (average of more than about 20 g/day as absolute 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)}
7. Subjects who have a smoking habit
8. Subjects who have difficulty maintaining a constant lifestyle during this trial, such as those who plan to make significant changes in their lifestyle (such as diet, sleep, and exercise), work night shifts or other rotating shifts, or plan to travel abroad
9. Subjects who have not been getting enough sleep
10. Subjects who have constipation
11. Subjects who are allergic to medicines and/or the test food related products
12. Subjects who are pregnant, lactating, or planning to become pregnant during this trial
13. Subjects who suffer from COVID-19
14. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial
15. Subjects who are judged as ineligible to participate in this study by the physician
Target sample size
20
Research contact person
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
t-takara@takara-clinic.com
Public contact
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
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
WAKAMOTO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
Name of secondary funder(s)
IRB Contact (For public release)
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
IRB@takara-clinic.com
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
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)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 31 | 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
24
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
| 2023 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 31 | Day |
Last modified on
| 2024 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058401
