UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043288 |
|---|---|
| Receipt number | R000049422 |
| Scientific Title | Effect of ingestion of fermented black maca-containing food "Aged black maca Macarhythm" on fatigue and QOL Placebo-controlled, double-blind, randomized, controlled trial |
| Date of disclosure of the study information | 2022/06/17 |
| Last modified on | 2024/06/18 15:49:03 |
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Basic information
Public title
Effect of ingestion of fermented black maca-containing food "Aged black maca Macarhythm" on fatigue and QOL
Placebo-controlled, double-blind, randomized, controlled trial
Acronym
Effect of ingestion of fermented black maca-containing food "Aged black maca Macarhythm" on fatigue and QOL
Scientific Title
Effect of ingestion of fermented black maca-containing food "Aged black maca Macarhythm" on fatigue and QOL
Placebo-controlled, double-blind, randomized, controlled trial
Scientific Title:Acronym
Effect of ingestion of fermented black maca-containing food "Aged black maca Macarhythm" on fatigue and QOL
Region
| Japan |
Condition
Condition
healthy individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For male and female subjects who are tired on a daily basis, we will continue to ingest fermented black maca-containing foods for 4 weeks and examine the effects on fatigue and QOL.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CFS (Chalder Fatigue Scale)
Fatigue VAS
QOLVAS
Athens Insomnia Scale
OSA sleep questionnaire
Urine frequency
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of study food for 4 weeks
Interventions/Control_2
Ingestion of control food substance for 4 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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Subjects of men and women aged 20 to 80
(2) Subjects who are tired on a daily basis
(3) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing.
Key exclusion criteria
(1) Subjects with a history of liver disease, renal disease, digestive system disease, heart disease, respiratory disease, peripheral angiopathy, and other diseases that may affect the results of this study, or subjects with a history of surgery
(2) Subjects with diseases currently being treated
(3) Subjects who have been diagnosed with psychiatric disorders such as chronic insomnia, depression, anxiety disorders, and schizophrenia
(4) Subjects with food and drug allergies
(5) Subjects on a diet
(6) Subjects with irregular lives
(7) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the test period
(8) Subjects who are continuously taking medicines (including OTC and prescription medicines)
(9) Subjects taking excessive alcohol intake
(10) Subjects who cannot stop drinking from the day before the test to the day of the test
(11) Pregnant, lactating, or prospective pregnant or lactating subjects during the study period
(12) Subjects who are participating in or will participate in other clinical trials at the start of this study, and within 4 weeks after the end of the study.
(13) Other subjects judged by the investigator to be inappropriate
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | MIura |
Organization
Miura Clinic, Medical Corporation Kanonkai
Division name
Internal Medicine
Zip code
530-0044
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
TEL
0661355200
info@miura-cl.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Terashima |
Organization
Oneness Support Co., Ltd.
Division name
Clinical Trial Division
Zip code
530-0044
Address
Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka
TEL
0648018917
Homepage URL
mterashima@oneness-sup.co.jp
Sponsor or person
Institute
Miura Clinic, Medical Corporation Kanonkai
Institute
Department
Personal name
Funding Source
Organization
Fraijeu 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
Miura Clinic, Medical Corporation Kanonkai IRB
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
Tel
0661355200
mterashima@miura-cl.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
医療法人花音会みうらクリニック（大阪府） Miura Clinic, Medical Corporation Kanonkai（Osaka）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 17 | 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
| 2021 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 09 | Day |
Last modified on
| 2024 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049422
