UMIN-CTR Clinical Trial

Basic information
Public title	Effect of the test food on sleep and fatigue - A randomized, double blinded, parallel group comparison study -
Acronym	Effect of the test food on sleep and fatigue
Scientific Title	Effect of the test food on sleep and fatigue - A randomized, double blinded, parallel group comparison study -
Scientific Title:Acronym	Effect of the test food on sleep and fatigue
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effect of the test food on sleep and fatigue after 4 weeks of ingestion.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	OSA-MA, fatigue VAS scores
Key secondary outcomes	AIS, PSQI-j, JESS, SMH, POMS2-AS scores, serum DHEA-S, serum cortisol, the ratio of serum DHEA-S and serum cortisol

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of test food 1 and placebo 1 for 4 weeks.
Interventions/Control_2	Intake of test food 2 and placebo 2 for 4 weeks.
Interventions/Control_3	Intake of test food 3 and placebo 2 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	30 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1.Participant who works on the week days (Monday through Friday). 2.Participant who has regular working days and non- working days (one must have at least 2 consecutive non-working days). 3.Participant whose T score of the Fatigue-Inertia for POMS2 is above 49, and T score of the Vigor-Activity for POMS2 is less than 51 at the pre-test. 4.Participant whose score for Athens Insomnia Scale is above 5.
Key exclusion criteria	1.Subject who is under medication treatment, dietetic therapy, or exercise therapy 2.Subject who is under sleep, stress, and/or fatigue treatment 3.Subject who has or has a history of diabetes, liver disease, kidney disease, heart disease, having troubles in adrenocortical hormone secretion, or other metabolic disease 4.Subject who has history of mental illness, chronic fatigue syndrome or sleep disturbance 5.Subject who has been diagnosed as or who is suspected as sleep apnea syndrome 6.Subject who is taking regular medication, or who has or had a history of serious disease that requires regular medication 7.Subject who is regularly taking medication, quasi-medicine, health food or food with functional claims that affect the test results 8.Subject who is a day shift worker or is involved in manual labor such as heavy object transportation 9.Subject whose working days and non-working days are irregular 10.Subject who is planning to work on more than 2 night shifts during the study period 11.Subject who showed abnormal clinical test results or cardiopulmonary function and has been decided as an inappropriate candidate for the present study 12.Subject who has an allergy for the test food 13.Subject who is currently pregnant or planning to get pregnant and breast feed the baby during the study period 14.Subject who has participated in other clinical studies within the last one months 15.Subject who cannot follow the regulations of the current study and cannot carry out the specified questionnaires 16.Subject who is decided as an inappropriate candidate according to the life style habit questionnaire 17.Subject who showed abnormal physical examination value and other clinical test values 18.Subject who is planning to go abroad during the study period, or is planning to go for a domestic travel for more than 7 consecutive days 19.Subject who is considered as an inappropriate candidate by the doctor in charge or the lead principal investigator
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Kei Middle name Last name Yui
Organization	FANCL Corporation
Division name	Research Institute, Health science research center
Zip code	244-0806
Address	12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL	045-820-3755
Email	ke-yui@fancl.co.jp

Public contact
Name of contact person	1st name Hiroyasu Middle name Last name Shimada
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Zip code	150-0021
Address	1-20-2, Ebisu-nishi, Shibuya-ku, Tokyo, Japan
TEL	03-5459-5329
Homepage URL
Email	h.shimada@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co.,Ltd.
Institute
Department

Funding Source
Organization	FANCL Corporation
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	Aisei Hospital Ueno Clinic Research Ethics Committee
Address	2-18-6, Higashiueno, Taitou-ku, Tokyo
Tel	03-6455-0880
Email	t.saito@ttc-smo.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	公益財団法人愛世会 愛誠病院 上野クリニック

Other administrative information
Date of disclosure of the study information	2019 Year 08 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	0
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	Terminated
Date of protocol fixation	2019 Year 09 Month 22 Day
Date of IRB	2019 Year 08 Month 23 Day
Anticipated trial start date	2019 Year 10 Month 01 Day
Last follow-up date	2019 Year 11 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 08 Month 28 Day
Last modified on	2019 Year 08 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043128