UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048951 |
|---|---|
| Receipt number | R000055772 |
| Scientific Title | Effects of continuous consumption of test foods on auditory function in subjects with perceived decline in hearing function -A single arm open-label study- |
| Date of disclosure of the study information | 2022/09/16 |
| Last modified on | 2023/03/17 17:27:28 |
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Basic information
Public title
Effects of continuous consumption of test foods on auditory function in subjects with perceived decline in hearing function -A single arm open-label study-
Acronym
Effects of continuous consumption of test foods on auditory function in subjects with perceived decline in hearing function -A single arm open-label study-
Scientific Title
Effects of continuous consumption of test foods on auditory function in subjects with perceived decline in hearing function -A single arm open-label study-
Scientific Title:Acronym
Effects of continuous consumption of test foods on auditory function in subjects with perceived decline in hearing function -A single arm open-label study-
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the effect of test foods on healthy subjects who feels that their auditory function is not as good as it used to be.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective effectiveness of auditory function
(Hearing Questionnaire 2002)
(Japanese version of the Hearing Disability and Handicap Scale)
(Hearing Handicap Inventory for Adults or Hearing Handicap Inventory for the Elderly)
(Visual analogue scale)
Objective auditory function
(Pure tone audiometry)
(iCI-2004)
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
12-weeks intake of the test food
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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Persons who received a sufficient explanation of the purpose and contents of the study, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document.
2.Japanese who are 40 years old or more and under 70 years old.
3.Persons who have perceived decline in hearing function.
4.Persons who have BMI of 18.5 kg/m2 or more and under 30 kg/m2.
Key exclusion criteria
1. Persons who are diagnosed with hearing loss or abnormalities related to auditory function.
2. Persons who use hearing aids.
3. Persons who are diagnosed with dementia or have a tendency of dementia.
4. Persons who have mental disorder and have a history of taking medication or attending hospital, or currently attend hospital.
5. Persons who are on exercise or diet therapy under the supervision of a physician.
6. Persons who have current or history of drug or alcohol dependence.
7. Smokers or those who stopped smoking within the past 12 months.
8. Persons who have irregular lifestyle due to night work, shift work, etc.
9. Persons who have extremely irregular eating, sleeping, and other lifestyle habits.
10. Persons who have who have extremely unbalanced diet.
11. Persons who have any allergies to the ingredients used in the test food.
12. Persons who regularly take large amounts of the ingredients contained in test food.
13. Persons who have any chronic illnesses with medication and who have any serious disease histories.
14. Persons who are taking medicines regularly.
15. Persons who use medicines or foods with health claims, that may affect auditory function and those who are unable to stop taking them during the study period.
16. Persons who are breast-feeding, pregnant and planning or wishing to become pregnant during the study period.
17. Persons who have participated in other studies within the past three months before the start of current study, or those who intend to participate in other studies after consenting to the current study.
18. Persons who plan to travel abroad within one month prior to each examination.
19.Persons who are judged to be unsuitable as subjects based on the results of the pre-intervention test.
20.Persons who have donated more than 200 mL of blood within one month or 400 mL of blood within three months.
21.Persons who were judged as inappropriate for study participant by the principal investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Chihiro |
| Middle name | |
| Last name | Nagayama |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
nagayama.chihiro@hc-sys.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Yoshida |
Organization
Macromill, Inc.
Division name
Life Science Department
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo
TEL
0120-998-017
Homepage URL
koh_yoshida@macromill.com
Sponsor or person
Institute
Macromill, Inc.
Institute
Department
Personal name
Funding Source
Organization
Macromill, Inc.
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
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18 Shirakane, Showa-ku, Nagoya city, Aichi, JAPAN
Tel
052-734-8885
soumu@hc-sys.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
| 2022 | Year | 09 | Month | 16 | 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
| 2022 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 16 | Day |
Last modified on
| 2023 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055772
