UMIN-CTR Clinical Trial

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
Email	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
Email	y-kohzai@kyowa-t.com

Sponsor
Institute	Yamazaki Otolaryngology Clinic
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054052