UMIN-CTR Clinical Trial

Basic information
Public title	A study for the effect of the test food on fatigue caused by stress in daily life
Acronym	A study for the effect of the test food on fatigue caused by stress in daily life
Scientific Title	A study for the effect of the test food on fatigue caused by stress in daily life
Scientific Title:Acronym	A study for the effect of the test food on fatigue caused by stress in daily life
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect of test food on fatigue caused by stress in daily life
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	-Fatigue sensation -Autonomic nervous function
Key secondary outcomes	-Mood status -Work performance -Cognitive function -Blood analysis

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 4 weeks
Interventions/Control_2	Intake of placebo 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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1)Males and females whose age of 20 years or more and less than 65 years 2)Subjects who answer the questionnaire that they have fatigue sensation in daily life 3)Subjects deemed fatigued based on their scores of VAS and Face scale at the screening 4)Subjects who work in the office 5)Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
Key exclusion criteria	1)Subjects receiving a medical treatment for serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders 2)Subjects having the chronic fatigue syndrome (CFS) , or subjects deemed to have severe fatigue such as idiopathic chronic fatigue by the investigator 3)Subjects who take regularly pharmaceuticals or quasi-drugs which having the efficacy for recovery from fatigue or nutritional supplements during physical fatigue 4)Subjects who take regularly Foods with Function Claims labeled the effect of attenuating fatigue sensation 5)Subjects who take regularly supplements of amino acids or proteins 6)Subjects who are heavy drinkers (>=60 g per day as pure alcohol) 7)BMI <18.5 kg/m2 and >=30 kg/m2 8)Subjects who have the possibility of primary diseases in autonomic nervous system 9)Subjects having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood) 10)Subjects who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study 11)Female subjects who are pregnant or lactating, or intending to become pregnant during the study 12)Subjects deemed unsuitable by the investigator
Target sample size	48

Research contact person
Name of lead principal investigator	1st name Tomoyuki Middle name Last name Mine
Organization	Ajinomoto Co., Inc.
Division name	Institute of Food Sciences and Technologies
Zip code	2108681
Address	1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL	044-223-4114
Email	tomoyuki_mine@ajinomoto.com

Public contact
Name of contact person	1st name Daichi Middle name Last name Shindo
Organization	Ajinomoto Co., Inc.
Division name	Institute of Food Sciences and Technologies
Zip code	2108681
Address	1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL	044-223-4114
Homepage URL
Email	daichi_shindo@ajinomoto.com

Sponsor
Institute	Soiken Inc.
Institute
Department

Funding Source
Organization	Ajinomoto Co., 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	IRB of Fukuda Clinic
Address	Shin-Osaka brick building 2F, 1-6-1 Miyahara, Yodogawa-ku, Osaka-shi, Osaka
Tel	06-6398-0203
Email	fukudaclinicIRB@gmail.com

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	2020 Year 07 Month 31 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	2020 Year 07 Month 18 Day
Date of IRB	2020 Year 03 Month 21 Day
Anticipated trial start date	2020 Year 08 Month 01 Day
Last follow-up date	2021 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	2020 Year 07 Month 27 Day
Last modified on	2022 Year 02 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047073