UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056168 |
|---|---|
| Receipt number | R000064165 |
| Scientific Title | Evaluation of the effect of food intake on improving sleep |
| Date of disclosure of the study information | 2025/09/19 |
| Last modified on | 2025/09/19 15:05:00 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of the effect of food intake on improving sleep
Acronym
Evaluation of the effect of food intake on improving sleep
Scientific Title
Evaluation of the effect of food intake on improving sleep
Scientific Title:Acronym
Evaluation of the effect of food intake on improving sleep
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of consuming test foods on sleep and fatigue
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep and fatigue assessment
Key secondary outcomes
Lifestyle assessment using a diary
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
Oral ingestion of the test food for 4 weeks
Interventions/Control_2
Oral ingestion 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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Males and females aged over 20 to under 60 when informed consent.
2) Suibjects who are dissatisfied with their sleep in daily life
3) Subjects who fully understand the purpose and content of the research and agree to participate in the research of their own free will
Key exclusion criteria
Subjects
1)with an irregular lifestyle.
2) engaged in manual labor such as day/night shifts, late night shifts, or heavy lifting, and those with irregular lifestyles.
3) unsuitable due to their alcohol consumption habits.
4) unsuitable due to their suitability to wear measurement equipment.
5) with an environment that interferes with sleep at bedtime.
6) suspected of, under treatment for, or with a history of sleep apnea syndrome (SAS).
7) who have or are suspected to have nocturia, benign prostatic hyperplasia, or overactive bladder.
8) with or with a history of chronic fatigue syndrome, psychiatric disorders, hypertension, or serious diseases.
9) who have difficulty in carrying out questionnaire, etc., based on pre-test.
10) who may have major depression based on pre-test major depression episode results.
11) who are pregnant, lactating, possibly pregnant during the pre-test, or who wish to become pregnant during the study.
12) taking pharmaceuticals (quasi-drugs) that may affect sleep and fatigue during the pre-test.
13) using health foods that claim effects on sleep and fatigue during the pre-test.
14) in the habit of consuming foods, pharmaceuticals, or quasi-drugs containing ingredients involved in the test food at least once a week.
15) with hay fever requiring medication.
16) with diseases requiring constant medication, under treatment, or with a serious disease or past history requiring medication.
17) who have participated in other clinical trials within the month prior to the pre-test or who wish to participate in other studies during the study period.
18) whose measurements during the pre-test significantly deviate from the reference range.
19) who may develop allergic symptoms to drugs or foods.
20) planning to change their lifestyle during the study period.
21) judged inappropriate based on lifestyle questionnaire results.
22) judged inappropriate based on the responsible physician's judgment.
Target sample size
76
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Iemoto |
Organization
Morinaga & Co., Ltd.
Division name
Health Science and Research Center, R&D institute
Zip code
230-8504
Address
2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama
TEL
045-571-6140
n-iemoto-jb@morinaga.co.jp
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Morinaga & Co., Ltd.
Division name
Health Science and Research Center, R&D institute
Zip code
230-8504
Address
2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama
TEL
045-571-6140
Homepage URL
t-yamaguchi-bc@morinaga.co.jp
Sponsor or person
Institute
Morinaga & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Morinaga & 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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
nakajima.megumi888@eps.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
| 2025 | Year | 09 | 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
73
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
| 2024 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 21 | Day |
Date of closure to data entry
| 2025 | Year | 04 | Month | 28 | Day |
Date trial data considered complete
| 2025 | Year | 04 | Month | 28 | Day |
Date analysis concluded
| 2025 | Year | 06 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 15 | Day |
Last modified on
| 2025 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064165
