UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045587 |
|---|---|
| Receipt number | R000052049 |
| Scientific Title | Effect of consumption of the test food on stress and sleep |
| Date of disclosure of the study information | 2023/12/31 |
| Last modified on | 2022/07/14 13:34:06 |
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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
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
sekii@rohto.co.jp
Sponsor or person
Institute
ROHTO Pharmaceutical co., ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052049
