UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059593 |
|---|---|
| Receipt number | R000068159 |
| Scientific Title | Investigation to confirm the effect of consuming the test food on improving sleep quality |
| Date of disclosure of the study information | 2025/10/30 |
| Last modified on | 2025/10/30 18:02:38 |
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Basic information
Public title
Investigation to confirm the effect of consuming the test food on improving sleep quality
Acronym
Investigation to confirm the effect of consuming the test food on improving sleep quality
Scientific Title
Investigation to confirm the effect of consuming the test food on improving sleep quality
Scientific Title:Acronym
Investigation to confirm the effect of consuming the test food on improving sleep quality
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of consuming the test food on sleep
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
OSA sleep inventory MA version
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
Intake of the test food for 30 days
Interventions/Control_2
Intake of the placebo food for 4 weeks
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
| 18 | years-old | <= |
Age-upper limit
| 23 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy men and women aged 18 to 23 years old
(2) Individuals who were determined to be highly likely to have sleep problems based on a sleep questionnaire
(3) Individuals who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing.
Key exclusion criteria
(1) Those who are undergoing drug treatment
(2) Those regularly taking items that may affect the results of the test, e.g., medications, food for specified health uses, foods with function claims, and health foods
(3) Those with past or current medical history of serious diseases in organs such as the heart, liver, kidney, or digestive system
(4) Those who are using pacemakers
(5) Those who were pregnant, suspected of being pregnant, or breastfeeding
(6) Those with extremely irregular dietary habits or lifestyle routines
(7) Those who consumed 200 g of onions (at least one onion) per day
(8) Those who have allergies to medications and food and are at risk of causing allergies related to the test food.
(9) Those diagnosed with sleep apnea syndrome or who were aware of their apnea condition
(10) Those who are unable to abstain from alcohol or smoking during the test period when samples are collected
(11) Those with a past medical and treatment history of sleeping disorder
(12) Those who are currently undergoing treatment for sleep disorders
(13) Those who plan to participate in another clinical trial after consenting to participate in this study.
(14) Others deemed unsuitable for participation in this study by the principal investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yasunari |
| Middle name | |
| Last name | Kayashima |
Organization
Yamanashi Gakuin Junior College
Division name
Department of Food and Nutrition
Zip code
4008575
Address
2-4-5 Sakaori, Kofu-shi, Yamanashi
TEL
055-224-1418
kayashima.yasunari@c2c.ac.jp
Public contact
Name of contact person
| 1st name | Yasushi |
| Middle name | |
| Last name | Ohgo |
Organization
Nissin Pharma Co., Ltd.
Division name
Health Science Research Institute
Zip code
3568511
Address
5-3-1 Tsurugaoka, Fujimino-shi, Saitama
TEL
049-267-3940
Homepage URL
ogo.yasushi@nisshin.com
Sponsor or person
Institute
Yamanashi Gakuin Junior College
Institute
Department
Personal name
Funding Source
Organization
Nissin Pharma 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
The Ethics Committee of Yamanashi Gakuin Junior College
Address
2-4-5 Sakaori, Kofu-shi, Yamanashi
Tel
055-224-1418
kayashima.yasunari@c2c.ac.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
| 2025 | Year | 10 | Month | 30 | 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
| 2025 | Year | 10 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 30 | Day |
Last modified on
| 2025 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068159
