UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047388 |
|---|---|
| Receipt number | R000054052 |
| Scientific Title | Study to confirm the effect of supplement intake on functional improvement in healthy men and women |
| Date of disclosure of the study information | 2023/04/11 |
| Last modified on | 2022/08/25 15:31:12 |
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Basic information
Public title
Study to confirm the effect of supplement intake on functional improvement in healthy men and women
Acronym
Study to confirm the effect of supplement intake on functional improvement in healthy men and women
Scientific Title
Study to confirm the effect of supplement intake on functional improvement in healthy men and women
Scientific Title:Acronym
Study to confirm the effect of supplement intake on functional improvement in healthy men and women
Region
| Japan |
Condition
Condition
N/A(healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify whether hearing functions improve in healthy adults taking supplements.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Hearing test
Key secondary outcomes
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of test food A for 16 weeks
Interventions/Control_2
Ingestion of test food B for 16 weeks
Interventions/Control_3
Ingestion of placebo for 16 weeks
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Japanese subjects aged 40-59 years.
2) Subjects who are healthy and Healthy persons who are not currently undergoing treatment for any serious illness.
3) Subjects who are concerned about their hearing.
4) Subjects with an average hearing level of less than 25 dB in a pure tone audiometry.
Key exclusion criteria
1) Subjects who consume foods containing the same ingredients as the test foods on a daily basis.
2) Subjects who are not negative on the antigen test (simplified method) for the new coronavirus.
3)Subjects who have difficulty participating in the study due to liver disease, kidney disease, heart disease, respiratory disorder, endocrine disorder, metabolic disorder, neuropathy, consciousness disorder, diabetes (according to the standards set by the Japan Diabetes Society), and other diseases.
4)Subjects who go to the hospital or take medication for the treatment of lifestyle-related diseases such as hypertension, hyperglycemia, hyperuricemia, heart disease, and high cholesterol.
5) Subjects who are allergic to test foods.
6) Subjects who may change their lifestyle significantly during the test period.
7) Subjects who are pregnant, breastfeeding or planning to become pregnant during the test period.
8) Subjects with a history of major surgery in the gastrointestinal tract area, such as gastrectomy, gastrointestinal suture, or intestinal resection.
9) Subjects with a history of serious cardiovascular disease.
10)Subjects who regularly use medicines and health foods / supplements (including Food for Specified Health Uses, Foods with Functional Claims, and Food with Nutrient Function Claims) that may affect this study (however, those who can stop taking them when consent is obtained are not applicable)
11) Subjects who are participating in other clinical trials or within 4 weeks of completing the trial.
12) Heavy alcohol drinkers and excessive smokers
13)Subjects with extremely irregular eating habits
14)Late night and irregular shift workers
15) Subjects who do not agree with the purpose of the examination after receiving the explanation of the examination beforehand.
16) Any other subjects who are deemed by the investigator to be inappropriate to participate in this study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | takeshi |
| Middle name | |
| Last name | kanaya |
Organization
Yamazaki Otolaryngology Clinic
Division name
Department
Zip code
060-0011
Address
1-16, kita 11-jo nisi 14-tyoume , tyuuou-ku Sapporo-shi, Hokkaido
TEL
011-200-9431
y-kohzai@kyowa-t.com
Public contact
Name of contact person
| 1st name | yoshimichi |
| Middle name | |
| Last name | kozai |
Organization
Kyowa Trial Co., Ltd.
Division name
Clinical Trials Division
Zip code
0640923
Address
1-40, minami 23-jo nisi 11-chome, chuo-ku Sapporo-shi, Hokkaido
TEL
08018692585
Homepage URL
y-kohzai@kyowa-t.com
Sponsor or person
Institute
Yamazaki Otolaryngology Clinic
Institute
Department
Personal name
Funding Source
Organization
KOBAYASHI Pharmaceutical Co., Ltd.
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
Yamazaki Otolaryngology Clinic Ethics Review Board
Address
1-16, kita 11-jo nisi 14-tyoume , tyuuu-ku Sapporo-shi, Hokkaido
Tel
011-757-3387
s-ito@kyowa-t.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
山崎耳鼻咽喉科クリニック
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 11 | 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 | 01 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 12 | 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 | 04 | Month | 04 | Day |
Last modified on
| 2022 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054052
