UMIN-CTR Clinical Trial

Basic information
Public title	Anti-fatigue effects and safety of test food in healthy male and female participants presenting with fatigue in daily activities
Acronym	Anti-fatigue effects and safety of test food in healthy male and female participants presenting with fatigue in daily activities
Scientific Title	Anti-fatigue effects and safety of test food in healthy male and female participants presenting with fatigue in daily activities:Randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym	Anti-fatigue effects and safety of test food in healthy male and female participants presenting with fatigue in daily activities:Randomized, placebo-controlled, double-blind, parallel-group comparison study
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of the test food on subjective symptoms related to QOL in daily life when ingested for 8 consecutive weeks.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Subjective symptoms of QOL in daily life
Key secondary outcomes

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
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of test food for 8 consecutive weeks
Interventions/Control_2	Intake of placebo for 8 consecutive 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	40 years-old <=
Age-upper limit	64 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Healthy male and female subjects aged 40 to 64 years who are feeling daily fatigue (2) Subjects who do not have chronic fatigue syndrome (3) Subjects who have not been treated for sleep disorders (4) 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 heart, liver, and kidney diseases (including complications of other diseases) (2) Subjects with a history of cardiovascular disease (3) Subjects with diabetes (4) Subjects with diseases currently being treated (5) Subjects who are allergic to food and drugs (6) Subjects with anemia symptoms (7) Subjects who go to the hospital for some illness or are treated with drugs and Chinese medicine (temporary administration is possible) (8) Subjects who play intense sports and subjects who are on a diet (9) Subjects with extremely irregular eating habits (10) 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 (11) Subjects who drink more than 60 g of average daily pure alcohol (12) Subjects who smoke an average of 21 or more cigarettes a day (13) Subjects who are participating in or will participate in other clinical trials at the start of this study (14) Other subjects judged by the investigator or the investigator to be inappropriate for the examination
Target sample size	60

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	530-004
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	Fuji-sangyo 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	2023 Year 07 Month 13 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	2022 Year 03 Month 17 Day
Date of IRB	2022 Year 03 Month 17 Day
Anticipated trial start date	2022 Year 04 Month 22 Day
Last follow-up date	2022 Year 07 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 04 Month 20 Day
Last modified on	2022 Year 11 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054207