UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046947 |
|---|---|
| Receipt number | R000053543 |
| Scientific Title | Effects of continuous intake of study foods on auditory function- double-blind, placebo-controlled, parallel-group study.- |
| Date of disclosure of the study information | 2023/12/04 |
| Last modified on | 2023/12/01 16:22:22 |
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Basic information
Public title
Effects of continuous intake of study foods on auditory function- double-blind, placebo-controlled, parallel-group study.-
Acronym
Effects of continuous intake of study foods on auditory function- double-blind, placebo-controlled, parallel-group study.-
Scientific Title
Effects of continuous intake of study foods on auditory function- double-blind, placebo-controlled, parallel-group study.-
Scientific Title:Acronym
Effects of continuous intake of study foods on auditory function- double-blind, placebo-controlled, parallel-group study.-
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the effectiveness of test foods on healthy subjects who feels that their auditory function is not as good as it used to be.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hearing in Noise Test-Japanese
Key secondary outcomes
(Secondary outcomes)
J-matrix test, temporal processing measurement, Visual Analog Scale
(Safety evaluation)
Vital signs, body measurements(weight,BMI), blood biochemistry, hematology, adverse events
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
24-weeks intake of the test food
Interventions/Control_2
24-weeks intake of the 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
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Japanese men and women whose age at the time of obtaining written consent is a healthy person and a hearing person between the ages of 40 and 70.
2.Subject who feels that their auditory function is not as good as it used to be.
3.Subject with BMI>=18.5kg/m2 and <25kg/m2 (not applicable to obesity).
4.Subject who has received sufficient explanation of the purpose and content of this test, has the ability to consent, volunteered voluntarily after fully understanding, and agreed to participate in writing.
Key exclusion criteria
1.Subject who has received a diagnosis (auditory processing disorder) related to deafness or abnormal hearing function by a doctor or a medical examination.
2.Subject who uses hearing aids.
3.Subject who has been or are prone to dementia in the past.
4.Subject who has been or are prone to depression in the past.
5.Subject who is attends the hospital due to mental or sleep disorders or have a history of mental illness in the past.
6.Subject who has or are prone to autism spectrum disorders, attention deficit hyperactivity disorder / attention deficit hyperactivity disorder in the past.
7.Subject who is currently undergoing medication or outpatient treatment due to some serious illness.
8.Subject who is currently exercising or dieting under the supervision of a doctor.
9.Subject with current or history of drug or alcohol dependence.
10.Subject who smokes or started smoking cessation within 12 months.
11.Subject with irregular life rhythms due to night shifts or shift work.
12.Subject who has extremely irregular eating or sleeping habits.
13.Subject who has an extremely unbalanced diet.
14.Subject who has serious diseases such as brain disease, malignant tumor, immune disease, diabetes, liver disease (hepatitis), renal disease, heart disease, thyroid disease, adrenal disease, and other serious current or past diseases such as metabolic disease.
15.Subject who uses or cannot refrains from using health foods, supplements, and medicines that affect hearing.
16.Subject who is extremely claustrophobic.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hidemasa |
| Middle name | |
| Last name | Toya |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0014
Address
Round Cross Tamachi 9F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
03-3431-1260
toya@huma-rd.co.jp
Public contact
Name of contact person
| 1st name | Hidemasa |
| Middle name | |
| Last name | Toya |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0014
Address
Round Cross Tamachi 9F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
03-3431-1260
Homepage URL
toya@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
non-disclosure
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
Ethics Committees of Yoga Allergy Clinic
Address
4-32-16 Yoga,Setagaya-ku,Tokyo 158-0097 Japan
Tel
03-5491-4478
jim@medipharma.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
| 2023 | Year | 12 | Month | 04 | 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
100
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
| 2022 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 16 | Day |
Date of closure to data entry
| 2023 | Year | 07 | Month | 05 | Day |
Date trial data considered complete
| 2023 | Year | 07 | Month | 12 | Day |
Date analysis concluded
| 2023 | Year | 08 | Month | 24 | Day |
Other
Other related information
(Exclusion criteria continued)
17.Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating.
18. Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study.
19.Subject who plans to travel abroad within one month before each inspection.
20.Subject who is judgedas an inappropriate candidate from test results at the time of the SCR.
21.Subject who has blood collection or donation more than 200mL within the past 1 month or more than 400mL within the past 3 months from the day of the consent acquisition.
22.Subject who is considered as an inappropriate candidate by the doctor in charge.
Management information
Registered date
| 2022 | Year | 02 | Month | 18 | Day |
Last modified on
| 2023 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053543
