UMIN-CTR Clinical Trial

Basic information
Public title	Effect of the Test Food on Male's Vitality and Energy.
Acronym	Effect of the Test Food on Male's Vitality and Energy.
Scientific Title	Effect of the Test Food on Male's Vitality and Energy.
Scientific Title:Acronym	Effect of the Test Food on Male's Vitality and Energy.
Region	Japan

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

Objectives
Narrative objectives1	This study aims to examine effect of the test food on male's vitality and energy and its safety.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	[1]Indexes to evaluate vitality and energy (Aging Male Symptoms; Week 0, Week 4[home survey], Week 8).
Key secondary outcomes	*Secondary indexes [1] Visual Analogue Scale (Week 0,Week 4[home survey], Week 8). [2] Blood testosterone (Week 0, Week 8). *Safety indexes [1] Blood pressure, pulsation (Week 0, Week 8). [2] Weight, body fat percentage, BMI (Week 0, Week 8). [3] Doctor's questions (Week 0, Week 8). [4] Subject's diary(From the first day of ingestion of a test material to the last day of the test).

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	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Oral ingestion of the test products (6 pills/day; 8 weeks).
Interventions/Control_2	Oral ingestion of the placebo products (6 pills/day; 8 weeks).
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	65 years-old >
Gender	Male
Key inclusion criteria	[1] Japanese males aged 40-64 years. [2] Individuals who are healthy and are not received treatment of disease. [3] Individuals who have physical, mental, and sexual general malaise of male menopause. [4] Individuals whose written informed consent has been obtained. [5] Individuals who can come to the designated venue for this study and be inspected. [6] Individuals judged appropriate for the study by the principal.
Key exclusion criteria	[1] Individuals whose AMS' total score is over 50. [2] Individuals whose AMS' mental subscale score is over 12. [3] Subjects who score 10 or more on QIDS-J [4] Individuals using medical products. [5] Individuals who have a history of diabetes, erectile dysfunction, benign prostatic hyperplasia, gastric ulcer, mental disease, taste disorder or anemia. [6] Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. [7] Individuals who are a patient or have a history of or endocrine disease. [8] Individuals who use a drug to treat a disease in the past 1 month. [9] Individuals whose BMI is over 30. [10] Individuals who are sensitive to foods, and medical products. [11] Individuals who will ingest health-promoting foods, foods for specified health uses, health foods, or supplements. [12] Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period. [13] Individuals who had a habit to ingest health functional foods (ex. Food for Specified Health Uses), health foods or supplements with effects on sleep or physical fatigue in the past 1 month or will ingest those foods during the test period. [14] Individuals who are alcoholism or excessively take alcohol (expressed in an amount of alcohol: over 60g/day). [15] Individuals who are a smoker. [16] Individuals whose life style will change during the test period (ex. travel for a long time). [17] Individuals who participated in other clinical studies in the past three months. [18] Individuals who are or whose family is an employee of a health food, functional food, or cosmetic company. [19] Individuals judged inappropriate for the trial by the principal.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Takahiro Middle name Last name Ono
Organization	Ueno-Asagao Clinic
Division name	Head
Zip code	110-0015
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL	+81-3-6240-1162
Email	info@ueno-asagao.clinc

Public contact
Name of contact person	1st name Ryoma Middle name Last name Shimizu
Organization	TES Holdings Co., Ltd.
Division name	Administrative Department of Clinical Trials
Zip code	110-0015
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL	+81-3-6801-8480
Homepage URL
Email	r.shimizu@tes-h.co.jp

Sponsor
Institute	TES Holdings Co., Ltd.
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	Ueno-Asagao Clinic Ethical Review Committee
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel	+81-3-6240-1162
Email	i.takahashi@tes-h.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 02 Month 05 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	Terminated
Date of protocol fixation	2022 Year 01 Month 19 Day
Date of IRB	2022 Year 01 Month 20 Day
Anticipated trial start date	2022 Year 02 Month 16 Day
Last follow-up date	2022 Year 04 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	In the midst of the spread of the new coronavirus (COVID-19), we decided to cancel the human clinical trial as a result of giving top priority to the safety of the subjects and staff.

Management information
Registered date	2022 Year 02 Month 04 Day
Last modified on	2022 Year 09 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053317