UMIN-CTR Clinical Trial

Basic information
Public title	Effects of food material(SIC-2019-05)
Acronym	Effects of food material(SIC-2019-05)
Scientific Title	Effects of food material(SIC-2019-05)
Scientific Title:Acronym	Effects of food material(SIC-2019-05)
Region	Japan

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

Objectives
Narrative objectives1	To confirm the effects of food material on sleep quality.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	sleep quality
Key secondary outcomes

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	Functional food, 4 weeks, once a day
Interventions/Control_2	Food without functional food, 4 weeks, once a day
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	40 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Subjects whose are 40 <= years old <= 75. (2) Subjects who can visit hospital on designated day. (3) Subject who is able to give written informed consent before the study.
Key exclusion criteria	(1) Subjects whose systolic blood pressure is less than 90mmHg (2) Subjects who donated 200 mL of blood and/or blood components within four weeks prior to the current study (3) Males whose blood was collected more than 400 mL within the last 12 weeks (4) Females whose blood was collected more than 400 mL within the last 16 weeks (5) Males whose blood was collected more than 1200 mL within the last twelve months when the amount of blood sampling in the current study is added (6) Females whose blood was collected more than 800 mL within the last twelve months when the amount of blood sampling in the current study is added (7) Subjects who are participating in other clinical studies for drug medicine or food, or who finished clinical study within four weeks (8) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Watanabe
Organization	SUNTORY GLOBAL INNOVATION CENTER LIMITED
Division name	Research Institute
Zip code	619-0284
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-0593
Email	H_Watanabe@suntory.co.jp

Public contact
Name of contact person	1st name Kosuke Middle name Last name Suzuki
Organization	SUNTORY GLOBAL INNOVATION CENTER LIMITED
Division name	Research Institute
Zip code	619-0284
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-0600
Homepage URL
Email	Kosuke_Suzuki@suntory.co.jp

Sponsor
Institute	SUNTORY GLOBAL INNOVATION CENTER LIMITED
Institute
Department

Funding Source
Organization	SUNTORY GLOBAL INNOVATION CENTER LIMITED
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	Ueno clinic institutional review board
Address	2-18-6 Higashiueno, Taito-ku, Tokyo, Japan
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

Other administrative information
Date of disclosure of the study information	2019 Year 09 Month 07 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	2019 Year 08 Month 22 Day
Date of IRB	2019 Year 08 Month 22 Day
Anticipated trial start date	2019 Year 09 Month 08 Day
Last follow-up date	2019 Year 12 Month 22 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 09 Month 03 Day
Last modified on	2020 Year 09 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043214