UMIN-CTR Clinical Trial

Basic information
Public title	Examination of influence on stress and fatigue in continuous intake of test food
Acronym	Examination of influence on stress and fatigue in continuous intake of test food
Scientific Title	Examination of influence on stress and fatigue in continuous intake of test food
Scientific Title:Acronym	Examination of influence on stress and fatigue in continuous intake of test food
Region	Japan

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

Objectives
Narrative objectives1	The objective of this study was to investigate the effect of the Examine the effects on fatigue and stress in men and women aged 20 years or older, 60 years or younger, who have received the continuously for 4 weeks.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	POMS2 shorter version
Key secondary outcomes	VAS questionnaire,Pittsburgh Sleep Quality Index,Cortisol (saliva), chromogranin A (saliva)

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	4-week intake of the test food
Interventions/Control_2	4-week intake of the placebo food
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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Japanese male and female aged between 20 and 60 years old at the time of the informed. 2)Subject who feels fatigue and stress routinely. 3)Subject who fatigues score (FI-T score) of POMS 2 abbreviated version is 50 points or more. 4)Subject who has understood the purpose of the study, and agreed to participate it by signing the written informed consent.
Key exclusion criteria	1)Subject who is taking medication or under medical treatment. 2)Subject who is under exercise therapy or dietetic therapy. 3)Subject who has an allergy for test food. 4)Subject who has or had a history of either medicine or alcohol dependence syndrome. 5)Subject who has or had a history of mental illness (depression) or sleep disturbance. 6)Subject who is on a night-shift or is a shift worker. 7)Subject whose lifestyle is extremely irregular. 8)Subject who has an unbalanced diet. 9)Subject who has current disease or history of diabetes, liver disease (hepatitis), kidney disease, serious disease such as heart disease, thyroid disease, adrenal disease, other metabolic diseases. 10)Subjects who has taken health foods, supplements, or drugs that may affect fatigue relief. 11)Subject who has routinely taken large amounts of drinks containing a lot of caffeine (equivalent to 7 cups of coffee / day or more). 12)Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study. 13)Subject who has blood drawn 200mL within the past 1 months or 400mL within the past 3 months from the day of the consent acquisition. 14)Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating. 15)Subject who is expected to have major changes or stress in their own home environment or work environment from one month before screening to the end of the exam (job change, move, marriage, etc.). 16)Subject who gets intense exercise every day. 17)Subject who smokes regularly om a daily(more than 20 cigarettes per day). 18)Subject who can't keep the daily records. 19)Subject who is judged as an inappropriate candidate according to the screening data. 20)Subject who is considered as an inappropriate candidate by the doctor in charge.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name toshimasa Middle name Last name higuchi
Organization	ASAHI SOFT DRINKS CORP
Division name	Product Development Laboratory
Zip code	302-0106
Address	1-1-21 Midori, Ibaraki Prefecture
TEL	0297-46-9935
Email	toshimasa.higuchi@asahiinryo.co.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Ochitani
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Zip code	108-0014
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	03-3431-1260
Homepage URL
Email	ochitani@huma-rd.co.jp

Sponsor
Institute	HUMA R&D CORP
Institute
Department

Funding Source
Organization	Asahi Beverage 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	Ethics Committees of Nihonbashi Egawa Clinic
Address	2F Kotobuki Build. 1-27-12 Yaesu Chuo-ku, Tokyo 103-0028 Japan
Tel	03-5204-0311
Email	jim@medipharma.co.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

Other administrative information
Date of disclosure of the study information	2019 Year 05 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	60
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	2019 Year 03 Month 04 Day
Date of IRB	2019 Year 03 Month 11 Day
Anticipated trial start date	2019 Year 04 Month 25 Day
Last follow-up date	2019 Year 06 Month 21 Day
Date of closure to data entry	2019 Year 07 Month 24 Day
Date trial data considered complete	2019 Year 07 Month 29 Day
Date analysis concluded	2019 Year 10 Month 11 Day

Other
Other related information

Management information
Registered date	2019 Year 05 Month 10 Day
Last modified on	2019 Year 10 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041790