UMIN-CTR Clinical Trial

Basic information
Public title	A study to evaluate the effects of food material on attenuating fatigue sensation
Acronym	A study to evaluate the effects of food material on attenuating fatigue sensation
Scientific Title	A study to evaluate the effects of food material on attenuating fatigue sensation
Scientific Title:Acronym	A study to evaluate the effects of food material on attenuating fatigue sensation
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 food material for 4 weeks on attenuating fatigue sensation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	VAS(fatigue sensation)
Key secondary outcomes	VAS(perceived stress, sleepiness, thirstiness, jitteriness), POMS2 Japanese version, blood test(natural killer cell activity, plasmacytoid dendritic cell activity, macrophage activity), saliva test(secretory immunoglobulin A), questionnaire on physical condition

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	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of test food(high-dose) for 4 weeks
Interventions/Control_2	Intake of test food(low-dose) for 4 weeks
Interventions/Control_3	Intake of placebo for 4 weeks
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1) Males and females whose age of 40 years or more and less than 65 years 2) Subjects who perceive fatigue sensation in daily life 3) 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 with serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders 2) Subjects with chronic fatigue syndrome (CFS), or subjects deemed to have severe fatigue such as idiopathic chronic fatigue by the investigator 3) Outpatients with chronic diseases 4) Subjects who take regularly pharmaceuticals or quasi-drugs which having the efficacy for recovery from fatigue or nutritional supplements during physical fatigue 5) Subjects who take regularly Foods with Function Claims labeled the effect of attenuating fatigue sensation or maintaining immune function 6) Subjects who take regularly health food rich in citric acid 7) Subjects who have the possibility of developing allergic symptoms by the test food 8) 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) 9) Subjects who took part in another study within 3 months prior to the start of the present study or who is currently taking part in another study 10) Female subjects who are pregnant or lactating, or intending to become pregnant during the study 11) Subjects with mental disorders such as depression, with sleep disorders requiring treatment 12) Subjects who have the plan to receive a vaccine such as the influenza vaccine or the COVID-19 vaccine from 2 weeks before to 4 weeks after the start of test food intake 13) Subjects who have the habit to do regularly vigorous exercise (e.g. marathon running) or have the plan to do so during the study 14) Subjects who have the plan to change their lifestyle (sleeping time, eating habits, etc.) significantly during the study 15) Subjects deemed unsuitable by the investigator
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Masakazu Middle name Last name Kobayashi
Organization	Kobayashi Pharmaceutical Co., Ltd.
Division name	Research & Development Dept. Healthcare Division
Zip code	567-0057
Address	1-30-3, Toyokawa, Ibaraki-shi, Osaka
TEL	070-1442-8687
Email	masa-kobayashi@kobayashi.co.jp

Public contact
Name of contact person	1st name Shinichi Middle name Last name Kashiwagi
Organization	Soiken Inc.
Division name	R&D Division
Zip code	560-0082
Address	Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka-shi, Osaka
TEL	06-6871-8888
Homepage URL
Email	kashiwagi_shinichi@soiken.com

Sponsor
Institute	Soiken Inc.
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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, Osaka, 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	医療法人弘正会ふくだ内科クリニック（大阪府）

Other administrative information
Date of disclosure of the study information	2021 Year 09 Month 12 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 08 Month 21 Day
Date of IRB
Anticipated trial start date	2021 Year 09 Month 13 Day
Last follow-up date	2021 Year 11 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	2021 Year 09 Month 10 Day
Last modified on	2021 Year 09 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051894