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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024620
Receipt No. R000028167
Scientific Title Effect of a Food on Aging Male's Physical Fatigue Reduction, and Vitality and Vigor
Date of disclosure of the study information 2018/01/22
Last modified on 2017/05/01

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

Objectives
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

Assessment
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)

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 (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

Eligibility
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

Research contact person
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

Public contact
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

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
Address
Tel
Email

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
2018 Year 01 Month 22 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 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
Other related information

Management information
Registered date
2016 Year 10 Month 29 Day
Last modified on
2017 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028167

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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