UMIN-CTR Clinical Trial

Basic information
Public title	A Study on the Effect of Test food on Subjective symptoms in Aging Men -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Acronym	A Study on the Effect of Test food on Subjective symptoms in Aging Men
Scientific Title	A Study on the Effect of Test food on Subjective symptoms in Aging Men -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Scientific Title:Acronym	A Study on the Effect of Test food on Subjective symptoms in Aging Men
Region	Japan

Condition
Condition	No
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the effect of test food on subjective symptoms in aging men
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	questionnaire
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Active food A, 8 weeks consumption
Interventions/Control_2	Active food B, 8 weeks consumption
Interventions/Control_3	Placebo food, 8 weeks consumption
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	35 years-old <=
Age-upper limit	65 years-old >
Gender	Male
Key inclusion criteria	1) Healthy males aged 35 to 64 years-old. 2) Subjects who are aware of feelings of decreased libido, etc. 3) Subjects whose total testosterone levels in blood are 250 ng/dL or over. 4) Subjects whose BMI are less than 30. 5) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria	1) Subjects who contract sexual dysfunction (erectile dysfunction, etc.). 2) Subjects who contract, are under treatment for serious diseases (e.g., diabetes, kidney and liver disease, and heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder. 3) Subjects who have a chronic disease and regularly use medications. 4) Subjects who have a history and/or a surgical history of digestive disease affecting digestion and absorption. 5) Subjects who are judged as unsuitable for the current study by screening test. 6) Subjects who can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims). 7) Subjects who have excessive alcohol intake more than approximately 20 g / day of pure alcohol equivalent or habit of drinking 4 or more days per week. 8) Subjects who can't stop drinking from a day before each measurement. 9) Subjects who have declared allergic reaction to ingredients of test food. 10) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism. 11) Subjects who are shiftworker and/or midnight-shift worker. 12) Subjects who plan to travel abroad, including overseas travel, during test periods. 13) Subjects who have donated over 200 mL of blood and/or blood components within the last 4 weeks prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study. 14) Subjects who are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study. 15) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Yoshitaka Middle name Last name Iwama
Organization	Nihonbashi Cardiology Clinic
Division name	Director
Zip code	103-0001
Address	Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL	03-5641-4133
Email	yiwama@well-sleep.jp

Public contact
Name of contact person	1st name Yoshika Middle name Last name Komori
Organization	KSO Corporation
Division name	Sales department
Zip code	105-0023
Address	1-9-7 Shibaura, Minato-ku, Tokyo
TEL	03-3452-7733
Homepage URL
Email	eigyou27@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	TOYO SHINYAKU 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	Ethical Committee of Kobuna Orthopedics Clinic
Address	5-656-17 Joto-machi, Maebashi-shi, Gunma
Tel	027-212-5608
Email	sagawa@mc-connect.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	2022 Year 05 Month 13 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	Preinitiation
Date of protocol fixation	2022 Year 04 Month 20 Day
Date of IRB
Anticipated trial start date	2022 Year 05 Month 14 Day
Last follow-up date	2022 Year 08 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 05 Month 13 Day
Last modified on	2022 Year 05 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054389

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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