UMIN-CTR Clinical Trial

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
Email	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
Email	mterashima@oneness-sup.co.jp

Sponsor
Institute	Miura Clinic, Medical Corporation Kanonkai
Institute
Department

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
Email	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	Preinitiation
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	2021 Year 02 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049422

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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