UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of a Food for Physical, Mental, and Sexual General Malaise in Male
Title of the study (Brief title)	Effects of a Food for Physical, Mental, and Sexual General Malaise in Male
Region	Japan

Condition
Condition	N/A(healthy adults with general malaise)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study examines effect of a food containing onion extract for physical, mental, and sexual general malaise in male.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	[1]Serum testosterone (Screening, Week 0, Week 2, Week 4) [2]Salivary testosterone (Screening, Week 0, Week 2, Week 4) [3]Aging Males' Symptoms scale (Screening, Week 0, Week 2, Week 4) [4]SF-36v2, Japanese version (Screening, Week 0, Week 2, Week 4) [5]IIEF (Screening, Week 0, Week 2, Week 4)
Key secondary outcomes	[1]Hematologic test (Screening, Week 0, Week 2, Week 4) [2]Blood biochemical test (Screening, Week 0, Week 2, Week 4) [3]Urine analysis (Screening, Week 0, Week 2, Week 4) [4]Blood pressure, pulsation (Screening, Week 0, Week 2, Week 4) [5]Weight, body fat percentage, BMI (Screening, Week 0, Week 2, Week 4) [6]Doctor's questions (Screening, Week 0, Week 2, Week 4) [7]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	Treatment
Type of intervention	Other
Interventions/Control_1	Oral ingestion of the test products containing onion extract (3 pills/day; 4 weeks)
Interventions/Control_2	Oral ingestion of the placebo products not containing onion extract (3 pills/day; 4 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	50 years-old <=
Age-upper limit	80 years-old >
Gender	Male
Key inclusion criteria	[1]Japanese males aged 50-79 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 AMS scale is 27-49 [5]Individuals whose written informed consent has been obtained [6]Individuals who can come to the designated venue for this study and be inspected [7]Individuals judged appropriate for the study by the principal
Key exclusion criteria	[1]Individuals using medical products [2]Individuals who have a habit to use or intake medicine [3]Individuals who have a history of diabetes, erectile dysfunction, benign prostatic hyperplasia, gastric ulcer, mental disease, taste disorder or anemia [4]Individuals who have a history of heart failure, kidney failure, hepatitis B or hepatitis C [5]Individuals who have a history of digestive system disease [6]Individuals whose AST or ALT is 1.5 times higher than the standard value [7]Individuals whose UA is over 7.0mg/dl [8]Individuals whose indexes concerning on lipid-based system is 2.0 times higher than the standard value [9]Individuals whose PSA value is over 4.0ng/mL [10]Individuals whose HbA1c(NGSP) is over 6.8 [11]Individuals whose systolic arterial pressure is over 160mmHg or diastolic blood pressure is over 100mmHg [12]Individuals whose BMI is over 30 [13]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day) [14]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months [15]Individuals whose average number of cigarettes for smoking is over 21/day [16]Individuals who participated in other clinical studies in the past three months [17]Individuals who are sensitive to foods and medical products [18]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplyments in the past 3 month or will ingest those foods during the test period [19]Individuals who have a habit to intake onion over 200g/day [20]Individuals whose life style will change during the test period (ex. a night shift, travel for a long time, job transfer) [21]Individuals judged inappropriate for the study by the principal
Target sample size	60

Research contact person
Name of lead principal investigator	Shigeo Horie
Organization	Juntendo Unviersity
Division name	Graduate School of Medicine
Address	2-1-1 Hongo Bunkyo-ku Tokyo 113-8421, JAPAN
TEL	03-5802-1227
Email	shorie@juntendo.ac.jp

Public contact
Name of contact person	Toshiyasu Tamura
Organization	TES Holdings Co., Ltd
Division name	Department of Clinical Trial
Address	6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL	03-6801-8480
Homepage URL
Email	info@tes-h.co.jp

Sponsor
Institute	TES Holdings Co., Ltd
Institute
Department

Funding Source
Organization	Nisshin Pharma Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 03 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 29 Day
Anticipated trial start date	2016 Year 03 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 03 Month 11 Day
Last modified on	2016 Year 08 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024466