UMIN-CTR Clinical Trial

Public title

Effect of a Food on Aging Male's Physical Fatigue Reduction, and Vitality and Vigor

Acronym

Effect of a Food on Aging Male's Physical Fatigue Reduction, and Vitality and Vigor

Scientific Title

Effect of a Food on Aging Male's Physical Fatigue Reduction, and Vitality and Vigor

Scientific Title:Acronym

Effect of a Food on Aging Male's Physical Fatigue Reduction, and Vitality and Vigor

Region

Japan

Condition

N/A(healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study examines effect of a food on aging male's physical fatigue reduction, and vitality and vigor.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

[1]Visual Analog Scale for Fatigue (Week 0, Week 6, Week 12)
[2]Total testosterone (Week 0, Week 6, Week 12)

Key secondary outcomes

*Secondary outcomes
[1]Salivary testosterone (Week 0, Week 6, Week 12)
[2]SF-36v2 Japanese version (Week 0, Week 6, Week 12)
[3]Japanese Translation of Profile of Mood States (Week 0, Week 6, Week 12)

*Safety
[1]Blood pressure, pulsation (Week 0, Week 6, Week 12)
[2]Weight, body fat percentage, BMI (Week 0, Week 6, Week 12)
[3]Abdominal perimeter (Week 0, Week 6, Week 12)
[4]Hematologic test (Week 0, Week 12)
[5]Blood biochemical test (Week 0, Week 12)
[6]Urine analysis (Week 0, Week 12)
[7]Doctor's questions (Week 0, Week 6, Week 12)
[8]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 (2 pills/day; 12 weeks)

Interventions/Control_2

Oral ingestion of the placebo products (2 pills/day; 12 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

40

years-old

<=

Age-upper limit

65

years-old

>=

Gender

Male

Key inclusion criteria

[1]Japanese males aged 40-65 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 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 use a drug to treat a disease in the past 1 month
[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 BMI is over 25
[8]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day)
[9]Individuals whose average number of cigarettes for smoking is over 21/day
[10]Individuals with serious anemia
[11]Individuals who are sensitive to test product or other foods, and medical products
[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-promoting foods, foods for specified health uses, health foods, or supplements with components contained in the test product in the past 3 month or will ingest those foods during the test period
[14]Individuals whose life style will change during the test period (ex. travel for a long time)
[15]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months
[16]Individuals who participated in other clinical studies in the past three months
[17]Individuals judged inappropriate for the study by the principal

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Atsuko Mori

Organization

Oriental Ueno Detection Center, General Incorporated Association Oriental Occupational Health Association Tokyo Branch

Division name

Director

Zip code

Address

1-20-11, Ueno, Taito-ku, Tokyo 110-0005 JAPAN

TEL

03-5816-0711

Email

info@tes-h.co.jp

Name of contact person

1st name
Middle name
Last name	Ryoma Shimizu

Organization

TES Holdings Co., Ltd.

Division name

Administrative Department of Clinical Trials

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

Kobayashi Pharmaceutical Co., Ltd.

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

2018

Year

01

Month

22

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

09

Month

16

Day

Date of IRB

Anticipated trial start date

2016

Year

10

Month

30

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

10

Month

29

Day

Last modified on

2017

Year

05

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028167