UMIN-CTR Clinical Trial

Basic information
Public title	The effects food intake during the day on sleep
Acronym	The effects food intake during the day on sleep
Scientific Title	The effects food intake during the day on sleep
Scientific Title:Acronym	The effects food intake during the day on sleep
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effects of food ingestion during the day on sleep
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sleep self-assessment
Key secondary outcomes	Sleep Quality Instrument Measurement Mood State Self-Assessment Pre-survey Pre-sleep survey Post-survey

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Test food
Interventions/Control_2	Control 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	70 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Healthy person from 20 to 70 years of age (2)A person who are anxious about sleep (3)A person who eats three meals a day ,regularly (4)A person who sleep more than 5 hours a day (5)A person who are able to go to bed and get up on time and live as usual during the test period (6)A person who can sleep in the same place for the during the test period (7)A person who refrain from exercise during the test period (8)A person who refrain from exercise during the test period (9)A person who refrain from consuming caffeine after dinner during the test period (10)A person who can come to the site on the first and last day of the test (11)A person who have eaten test food and control food and have no problems with intake
Key exclusion criteria	(1)Pregnat,lactating or menstruating women during the test period (2)A person in an environment that may affect sleep (3)A person who take sleep-related treatments,medications or supplements (4)A person who have food allergies (5)A person who have allergies to metal,rubber,etc
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Hideo Middle name Last name Jinguu
Organization	Kanazawa Institute of Technology
Division name	Department of Information Frontier Studies,Psychological Sciences Section
Zip code	924-0838
Address	3-1, Yatsukaho, Hakusan-shi, Ishikawa
TEL	076-274-7296
Email	jinguh@neptune.kanazawa-it.ac.jp

Public contact
Name of contact person	1st name Kenji Middle name Last name Osawa
Organization	Lotte Co., Ltd.
Division name	Central Laboratory, Kamukoto Research Department
Zip code	336-8601
Address	1-1, Numakage-3chome, Minami-ku, Saitama
TEL	048-837-0744
Homepage URL
Email	Oosawa_Kenji@lotte.co.jp

Sponsor
Institute	Lotte Co., Ltd.
Institute
Department

Funding Source
Organization	Lotte Co., Ltd.
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	Shiba Palace Clinic
Address	6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel	03-5408-1590
Email	jimukyoku@mail.souken-r.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 08 Month 19 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	62
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 08 Month 05 Day
Date of IRB	2020 Year 07 Month 02 Day
Anticipated trial start date	2020 Year 08 Month 26 Day
Last follow-up date	2020 Year 12 Month 15 Day
Date of closure to data entry	2020 Year 12 Month 15 Day
Date trial data considered complete	2021 Year 01 Month 15 Day
Date analysis concluded	2021 Year 02 Month 03 Day

Other
Other related information

Management information
Registered date	2020 Year 08 Month 18 Day
Last modified on	2021 Year 02 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047320