UMIN-CTR Clinical Trial

Public title

Effects of a Food for Physical, Mental, and Sexual General Malaise in Male

Acronym

Effects of a Food for Physical, Mental, and Sexual General Malaise in Male

Scientific Title

Effects of a Food for Physical, Mental, and Sexual General Malaise in Male

Scientific Title:Acronym

Effects of a Food for Physical, Mental, and Sexual General Malaise in Male

Region

Japan

Condition

N/A(healthy adults with general malaise)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Shigeo Horie

Organization

Juntendo Unviersity

Division name

Graduate School of Medicine

Zip code

Address

2-1-1 Hongo Bunkyo-ku Tokyo 113-8421, JAPAN

TEL

03-5802-1227

Email

shorie@juntendo.ac.jp

Name of contact person

1st name
Middle name
Last name	Toshiyasu Tamura

Organization

TES Holdings Co., Ltd

Division name

Department of Clinical Trial

Zip code

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

Institute

TES Holdings Co., Ltd

Institute

Department

Personal name

Organization

Nisshin Pharma Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

03

Month

12

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2016

Year

02

Month

29

Day

Date of IRB

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

Other related information

Registered date

2016

Year

03

Month

11

Day

Last modified on

2016

Year

08

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024466