UMIN-CTR Clinical Trial

Basic information
Public title	Effect of consumption of the test food on stress and sleep
Acronym	Effect of consumption of the test food on stress and sleep
Scientific Title	Effect of consumption of the test food on stress and sleep
Scientific Title:Acronym	Effect of consumption of the test food on stress and sleep
Region	Japan

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

Objectives
Narrative objectives1	To verify the effect of consumption of the test food on stress and sleep
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Changes in scores (by factor) OSA sleep inventory MA version
Key secondary outcomes	1. Changes in scores (by item, and total) of OSA sleep inventory MA version (item, total) 2. Changes in sleep-related data obtained from sleep measurement devices 3. Changes in salivary cortisol levels 4. Changes in the amount of IgA in saliva 5. VAS (for stress) 6. Questionnaire

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	28 days ingestion of test food
Interventions/Control_2
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
Key inclusion criteria	1. Subjects who are stressed and dissatisfied with their sleep. 2. Subjects who have a holidays on Saturdays and Sundays and do not work in shifts.
Key exclusion criteria	1. Subjects who smoke 2. Those undergoing treatment for chronic diseases 3. Subjects who have a serious disease of the heart, liver, kidneys, digestive organs, etc., or a current or history of mental illness 4. Subjects who routinely use or consume medicines such as antihistamines and antiallergic agents, health foods and supplements (theanine, glycine, etc. claimed to have effects on sleep and stress) that may affect the test results 5. Subjects who have a history or current illness of allergies that may affect the test results 6. Subjects who have BMI of 25 kg/m2 or more 7. Subjects who wake up more than three times between going to bed and waking up because of urination, itching, nasal congestion, etc. 8. Subjects who are extremely irregular, such as having dinner after 10:00 p.m. on more than three days in a week 9. Subjects who do not have a routine timing for bathing 10. Subjects who drink excessive amounts of alcohol (20g or more) on a daily basis 11. Subjects who share a bedroom with preschool children or pets 12. Subjects who need to get up frequently during the night, for example, because they live with children or people who need nursing care 13. Subjects who are judged as ineligible to participate in the study by principal investigator or sub-investigator
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Kazutake Middle name Last name Fukada
Organization	ROHTO Pharmaceutical co., ltd.
Division name	Internal Medicine & Food Development Division
Zip code	544-8666
Address	1-8-1, Tatsumi-nishi, Ikuno-ku, Osaka
TEL	06-6758-9848
Email	fukada@rohto.co.jp

Public contact
Name of contact person	1st name Yukiko Middle name Last name Sekii
Organization	ROHTO Pharmaceutical co., ltd.
Division name	Internal Medicine & Food Development Division
Zip code	544-8666
Address	1-8-1, Tatsumi-nishi, Ikuno-ku, Osaka
TEL	06-6758-9848
Homepage URL
Email	sekii@rohto.co.jp

Sponsor
Institute	ROHTO Pharmaceutical co., ltd.
Institute
Department

Funding Source
Organization	ROHTO Pharmaceutical 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	Clinical Research Ethics Review committee of ROHTO Pharmaceutical Co., Ltd.
Address	1-8-1, Tatsumi-nishi, Ikuno-ku, Osaka
Tel	06-6758-6925
Email	katsu@rohto.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	2023 Year 12 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	Completed
Date of protocol fixation	2021 Year 09 Month 27 Day
Date of IRB	2021 Year 10 Month 05 Day
Anticipated trial start date	2021 Year 10 Month 21 Day
Last follow-up date	2021 Year 12 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	2021 Year 09 Month 28 Day
Last modified on	2022 Year 07 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052049