UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059216 |
|---|---|
| Receipt number | R000067729 |
| Scientific Title | Effects of Maca Intake on Male Fatigue Resistance and Quality of Life |
| Date of disclosure of the study information | 2025/11/30 |
| Last modified on | 2025/09/27 16:14:16 |
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Basic information
Public title
Effects of Maca Intake on Male Fatigue Resistance and Quality of Life
Acronym
Effects of Maca Intake on Male Fatigue Resistance and Quality of Life
Scientific Title
Effects of Maca Intake on Male Fatigue Resistance and Quality of Life
Scientific Title:Acronym
Effects of Maca Intake on Male Fatigue Resistance and Quality of Life
Region
| Japan |
Condition
Condition
Healthy adult males
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether maca intake improves fatigue and quality of life in men.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fatigue-related VAS, Vigar-Activity (VA) using POMS2
Key secondary outcomes
Salivary testosterone, POMS2 Quality of Life Assessment (excluding Viger-Activity), AMS Score, IIEF5 Score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
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
Foods containing maca-derived ingredients
Interventions/Control_2
Placebo food
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
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
(1) Healthy adult males
(2) Individuals with a BMI below 30 kg/m2
Key exclusion criteria
(1) Individuals currently receiving medication for any medical condition
(2) Individuals consuming foods or health supplements containing the active ingredient of this test food
(3) Individuals with functional erectile dysfunction
(4) Individuals with serious diseases or psychiatric disorders affecting glucose metabolism, lipid metabolism, liver function, kidney function, heart, circulatory system, respiratory system, endocrine system, immune system, or nervous system; and individuals with a history of such conditions
(5) Individuals who have shown abnormal clinical laboratory values in recent health checkups and are deemed unsuitable for trial participation
(6) Individuals with currently treated diseases or a history of serious diseases requiring medication
(7) Individuals at risk of developing allergies related to the trial
(8) Individuals deemed unsuitable as subjects based on responses to the lifestyle questionnaire
(9) Individuals participating in other clinical studies at the start of this trial
(10) Individuals deemed unsuitable for trial participation by the Principal Investigator (or Study Director)
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 3-11-1, Kashiwara, Osaka
TEL
0729780088
rtakeda@tamateyama.ac.jp
Public contact
Name of contact person
| 1st name | Shigefumi |
| Middle name | |
| Last name | Nibun |
Organization
EAS inc.
Division name
Clinical Trial Session
Zip code
239-0028
Address
Susaki-Cho1-10-2F, Kanazawa-ku, Yokohama city, Kanagawa
TEL
045-374-3392
Homepage URL
info@eas-ct.jp
Sponsor or person
Institute
Sukoyaka-Kobo Inc.
Institute
Department
Personal name
Funding Source
Organization
Sukoyaka-Kobo 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
027-261-7600
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
| 2025 | Year | 11 | 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
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
Preinitiation
Date of protocol fixation
| 2024 | Year | 08 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2025 | Year | 09 | Month | 27 | Day |
Last modified on
| 2025 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067729
