UMIN-CTR Clinical Trial

Basic information
Public title	Effect of functional food on the improvement for male sexual function
Acronym	Effect of functional food on the improvement for male sexual function
Scientific Title	Effect of functional food on the improvement for male sexual function
Scientific Title:Acronym	Effect of functional food on the improvement for male sexual function
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We examine the effect of functional food on the improvement for male sexual function, and the safety.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	IIEF15
Key secondary outcomes	Various questionnaires

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	Ingestion of functional food for 12 weeks
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	30 years-old <=
Age-upper limit	80 years-old >
Gender	Male
Key inclusion criteria	1. Japanese men aged greater than or equal to 30 years, less than 80 years at the time of obtaining informed consent. 2. Subjects with IIEF-EF domain score of 11 to 21 at screening. 3. Subjects with AMS score of 27 to 49 at screening. 4. Subjects who have attempted heterosexual intercourse at least once every 4 weeks. 5. Subjects who got adequate explanation about the purpose and details of the examination, have the capacity to consent, voluntarily participate in understanding, and agree to participate in the examination in writing.
Key exclusion criteria	1. Subjects who have received ED treatment or infertility treatment. 2. Subjects who have past or current medical history related to urology such as prostatic hypertrophy. 3. Subjects who have received for depression treatment or may have depression. 4. Subjects who have liver disorder, kidney disorder, heart disease, organ disorder, diabetes, hypertension, dyslipidemia, or other serious diseases. 5. Subjects who have had a history of gastrointestinal tract surgery, such as gastrectomy, gastrointestinal suture, or bowel resection. 6. Subjects have received medication. 7. Subjects who have received hormone replacement therapy. 8. Subjects who have irregular lifestyle habits due to night shift or shift work. 9. Subjects who use excessive tobacco or alcohol, or have extremely irregular eating habits. 10. Subjects who have allergies such as food allergies or asthma. 11. Subjects who regularly use drugs, specified health foods, health foods, or supplements that may affect this study. 12. Subjects who had participated in other clinical studies within the last three month prior to the current study. 13. Subjects who do not agree with the purpose of the explanation given in advance. 14. Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Masanori Middle name Last name Akanuma
Organization	Akanuma Surgery Clinic
Division name	Director
Zip code	005-0842
Address	2-6-14-1, Ishiyama, Minami-ku, Sapporo, Hokkaido
TEL	011-591-1777
Email	y-kohzai@kyowa-t.com

Public contact
Name of contact person	1st name Yoshimichi Middle name Last name Kohzai
Organization	Kyowa Trial Co., Ltd.
Division name	President
Zip code	064-0923
Address	mimami23-nishi11-1-40, Chuo-ku, Sapporo, Hokkaido
TEL	011-200-9431
Homepage URL
Email	y-kohzai@kyowa-t.com

Sponsor
Institute	Kyowa Trial Co., Ltd.
Institute
Department

Funding Source
Organization	Yamada Bee Company, 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	Akanuma Surgery Clinic Ethics Review Committee
Address	2-6-14-1, Ishiyama, Minami-ku, Sapporo, Hokkaido
Tel	011-591-1777
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

Other administrative information
Date of disclosure of the study information	2021 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	15
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	2020 Year 01 Month 21 Day
Date of IRB	2020 Year 01 Month 21 Day
Anticipated trial start date	2020 Year 01 Month 30 Day
Last follow-up date	2020 Year 04 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	2020 Year 01 Month 29 Day
Last modified on	2021 Year 03 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044826