UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055821 |
|---|---|
| Receipt number | R000063802 |
| Scientific Title | The effects of plant extract intake on male anti-fatigue and QOL |
| Date of disclosure of the study information | 2024/12/30 |
| Last modified on | 2025/10/12 12:51:42 |
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Basic information
Public title
The effects of plant extract intake on male anti-fatigue and QOL
Acronym
The effects of plant extract intake on male anti-fatigue and QOL
Scientific Title
The effects of plant extract intake on male anti-fatigue and QOL
Scientific Title:Acronym
The effects of plant extract intake on male anti-fatigue and QOL
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating the improvement of male function and quality of life through the intake of plant extracts
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quality of daily life, fatigue
Key secondary outcomes
Salivary testosterone
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
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Consumption of food containing plant extracts
Interventions/Control_2
Consumption of food placebo
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
| 30 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male
Key inclusion criteria
(1) Healthy men in their 30s to 50s who are concerned about the decline in male function in recent years
(2) Those with a BMI of less than 30kg/m2
(3) Men who are not currently engaging in sexual activity with the aim of becoming pregnant
(4) Those who are not undergoing infertility treatment
(5) Those who are not currently smoking (those who have been abstaining from smoking for more than one year)
(6) Those who can provide written consent to participate in the study voluntarily
Key exclusion criteria
(1) Those currently taking medication for any kind of disease
(2) Those taking the test food or health food products containing the active ingredient of the test food
(3) Those with functional erectile dysfunction
(4) Those with serious diseases of the sugar metabolism, lipid metabolism, liver function, kidney function, heart, circulatory system, respiratory system, endocrine system, immune system, or nervous system, or those with mental disorders. and those with a history of such conditions
(5) Those who have been judged to have a problem with participating in the trial due to abnormalities in their clinical test values in their most recent health checkup, etc.
(6) Those with a current illness or a history of a serious illness that required medication
(7) Those who may develop an allergy in relation to the study
(8) Those who are judged to be unsuitable as test subjects based on the results of the lifestyle questionnaire
(9) Those who are participating in other clinical research at the start of this study
(10) Those who are judged to be unsuitable for participation in the study by the principal investigator (or the person in charge of conducting the study)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ryuji |
| Middle name | |
| Last name | Takeda |
Organization
Kansai University of Welfare Sciences
Division name
Department of Nutritional Sciences for Welll-being Faculty of Health Science for Welfare
Zip code
582-0026
Address
Asahigaoka 3-11-, Kashiwara-city, Osaka, Japan
TEL
072-978-0088
rtakeda@tamateyama.ac.jp
Public contact
Name of contact person
| 1st name | Shigenori |
| Middle name | |
| Last name | Nibun |
Organization
EAS Inc.
Division name
Clinical Trial Session
Zip code
236-0028
Address
Susaki-cho 1-10-2F, Kanazawa-ku, Yokohama, kanagawa
TEL
045-228-5243
Homepage URL
info@eas-ct.jp
Sponsor or person
Institute
EAS Inc.
Institute
Department
Personal name
Funding Source
Organization
Sukoyaka Koubo Inc.
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
KOBUNA ORTHOPEDIC SURGERY
Address
311-2, Gokan-machi, Maebashi, Gunma
Tel
027-212-5608
sagawa@mc-connect.co.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
| 2024 | Year | 12 | Month | 30 | 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
50
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
| 2024 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 12 | Day |
Last modified on
| 2025 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063802
