UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000036485 |
|---|---|
| Receipt number | R000041570 |
| Scientific Title | Effect of the compound supplements on QOL in adult men after ingestion of the supplements for 8 weeks |
| Date of disclosure of the study information | 2019/04/15 |
| Last modified on | 2020/04/13 10:25:34 |
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Basic information
Public title
Effect of the compound supplements on QOL in adult men
Acronym
Effect of the compound supplements on QOL in adult men
Scientific Title
Effect of the compound supplements on QOL in adult men after ingestion of the supplements for 8 weeks
Scientific Title:Acronym
Effect of the compound supplements on QOL in adult men after ingestion of the supplements for 8 weeks
Region
| Japan |
Condition
Condition
Male menopausal symptoms
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of the compound supplements on QOL in adult men after ingestion of the supplements for 8 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in fatigue VAS after ingestion of the supplements for 8 weeks.
Key secondary outcomes
Changes in AMS score anti aging,QOL total blood testosterone and free blood testosteronea after ingestion of the supplements for 8 weeks.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male
Key inclusion criteria
1)Japanese male aged 20 to 75 at the time of informed consent.
2)Subjects who made a visit to outpatient clinic for male menopause and are diagnosed not to need medication for male menopause symptoms.
3) Subjects who need watch and wait and decide to use health food and the like by their own will for the purpose of nutrition support that is insufficient in the diet..
4) Subjects who will intake the compound supplements.
Key exclusion criteria
1)Subjects who are suspected to have serious disease such as digestive, liver, kidney, circulatory, blood, and endocrine disorder or who have the history of these disorders.
2) Subjects who are judged to require testosterone replacement therapy at outpatient clinic
3)Subjects who are judged to require administration of PDE-5 inhibitor at outpatient clinic
4)Subjects who are judged to require the administration of antidepressants or anti-anxiety drug at outpatient clinics
5)Subjects who are currently taking a supplement which contains a same functional substance as the compound supplements
6)Subjects who may cause allergic reactions to foods
7)Subjects who are heavy smoker or heavy user of alcohol
8)Subjects who are judged as unsuitable for the study by the investigator with other reasons.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Yui |
Organization
FANCL Corporation
Division name
Research Institute
Zip code
045-820-3569
Address
Kamishinano 12-13, Totsuka-ku, Yokohama, Kanagawa
TEL
045-820-3659
tsubokawa_masaya@fancl.co.jp
Public contact
Name of contact person
| 1st name | Isao |
| Middle name | |
| Last name | Takehara |
Organization
Clinical Support Corpration
Division name
Food Service Division
Zip code
060-0061
Address
12-13 Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
TEL
045-820-3569
Homepage URL
takehara@csc-smo.co.jp
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
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
Medical corporation Hokubukai beauty hill hospital ethics review committee
Address
No. 61, Maeda, Kiyota-ku, Sapporo, Hokkaido
Tel
011-882-0111
wakimoto@ughp-cpc.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
| 2019 | Year | 04 | Month | 15 | 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
45
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
| 2019 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 04 | Month | 12 | Day |
Last modified on
| 2020 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041570
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