UMIN-CTR Clinical Trial

Basic information
Public title	Effect of test food on fatigue in subjects : a randomized, double-blind, placebo-controlled, cross-over trial.
Acronym	Effect of test food on fatigue in subjects
Scientific Title	Effect of test food on fatigue in subjects : a randomized, double-blind, placebo-controlled, cross-over trial.
Scientific Title:Acronym	Effect of test food on fatigue in subjects
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effect of fatigue with test food in subjects with a tendency of fatigue.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	fatigue VAS
Key secondary outcomes	CFS

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	Treatment
Type of intervention	Food
Interventions/Control_1	A test food per day for 2 weeks.
Interventions/Control_2	A placebo food per day for 2 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	69 years-old >=
Gender	Male and Female
Key inclusion criteria	Fatigue tendency
Key exclusion criteria	1. Subjects with food allergies 2. Subjects who are pregnant or lactating 3. Subjects who consume medicinal product which may influence the outcome of the study 4.Subjects who consume food which may influence the outcome of the study 5. Subjects who are judged as unsuitable for the study by the investigator for the other reason
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masatomo Najima
Organization	Japan clinical trial assosiation
Division name	N.A.
Zip code
Address	4-3-17 shinjyuku, shinjyukuku, Tokyo
TEL	03-6457-4666
Email	info@yakujihou.org

Public contact
Name of contact person	1st name Middle name Last name Hirohisa Kojima
Organization	Japan clinical trial assosiation
Division name	N.A.
Zip code
Address	4-3-17 shinjyuku, shinjyukuku, Tokyo
TEL	03-6457-4666
Homepage URL
Email	info@yakujihou.org

Sponsor
Institute	Japan clinical trial assosiation
Institute
Department

Funding Source
Organization	FUJISANGYO 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
Address
Tel
Email

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	2017 Year 08 Month 16 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	2017 Year 07 Month 19 Day
Date of IRB	2017 Year 07 Month 19 Day
Anticipated trial start date	2017 Year 08 Month 19 Day
Last follow-up date	2018 Year 01 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 08 Month 16 Day
Last modified on	2020 Year 03 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032849