UMIN-CTR Clinical Trial

Basic information
Public title	Trial of the efficacy of food ingredients on sleep quality in healthy men and women (SWE-2019-10)
Acronym	Trial of the efficacy of food ingredients on sleep quality in healthy men and women
Scientific Title	Trial of the efficacy of food ingredients on sleep quality in healthy men and women (SWE-2019-10)
Scientific Title:Acronym	Trial of the efficacy of food ingredients on sleep quality in healthy men and women
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effect of food ingredients 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	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of the test foods A (8 weeks)
Interventions/Control_2	Intake of the test foods B (8 weeks)
Interventions/Control_3	Intake of the control foods (8 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) Women and men aged 40 to 64 years. 2) Person who feels poor sleep quality. 3) Person who gets a score of 6 or higher in the Japanese version of the Pittsburgh Sleep Quality Index 4) Person who can come to the medical and inspection organizations for the measurement at the date of visiting. 5) Person who can understand the purpose and content of this study and agree in writing to participate in this study.
Key exclusion criteria	1) Person who are living irregularly 2) Person whose engage in shift work. 3) Use of product affecting the data of this study, such as food for specified health use, food with function claims, and medicine. 4) Presence of previous and present disease such as insomnia, sleep apnea syndrome, mental disorder, lung disorder, cardiovascular disorder, diabetes mellitus, food allergy. 5) Investigator's judgment for other reason.
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Norifumi Middle name Last name Tateishi
Organization	SUNTORY WELLNESS LIMITED
Division name	Institute For Health Care Science
Zip code	619-0284
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-0655
Email	Norifumi_Tateishi@suntory.co.jp

Public contact
Name of contact person	1st name Masaru Middle name Last name Kominami
Organization	SUNTORY WELLNESS LIMITED
Division name	Institute For Health Care Science
Zip code	619-0284
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-0667
Homepage URL
Email	Masaru_Kominami@suntory.co.jp

Sponsor
Institute	SUNTORY WELLNESS LIMITED
Institute
Department

Funding Source
Organization	SUNTORY WELLNESS 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	Institutional Review Board of Chiyoda Paramedical Care Clinic
Address	2F SANWA UCHIKANDA Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo, Japan
Tel	03-5297-5548
Email	IRB@cpcc.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	2021 Year 05 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
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	2020 Year 01 Month 17 Day
Date of IRB
Anticipated trial start date	2020 Year 04 Month 08 Day
Last follow-up date	2020 Year 06 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	2020 Year 02 Month 20 Day
Last modified on	2020 Year 02 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045104