UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058045 |
|---|---|
| Receipt number | R000066271 |
| Scientific Title | Effects of continuous intake of the test food on sleep quality: a randomized, placebo-controlled, double-blind crossover trial |
| Date of disclosure of the study information | 2025/06/03 |
| Last modified on | 2025/05/30 12:18:51 |
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Basic information
Public title
Effects of continuous intake of the test food on sleep quality: a randomized, placebo-controlled, double-blind crossover trial
Acronym
Effects of continuous intake of the test food on sleep quality
Scientific Title
Effects of continuous intake of the test food on sleep quality: a randomized, placebo-controlled, double-blind crossover trial
Scientific Title:Acronym
Effects of continuous intake of the test food on sleep quality
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of a four-week continuous intake of the test food sleep quality, a randomized, double-blind, placebo-controlled, crossover trial will be conducted in healthy adults aged 20 to under 65 years who report dissatisfaction with their sleep.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
(1) Sleep Parameters
Key secondary outcomes
(1) Karolinska Sleepiness Scale (KSS)
(2) Visual Analogue Scale (VAS) Questionnaire
(3) State-Trait Anxiety Inventory (STAI)
(4) Snoring Parameters
(5) Gut Microbiota in Fecal Samples
(6) Short-Chain Fatty Acids in Fecal Samples
(7) Salivary Stress Markers
(8) Inflammatory Markers in Blood
(9)Biometric Data Collected via Wearable Devices
(10)Stool Frequency and Consistency
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consume the test food for 4 weeks, followed by the placebo food for another 4 weeks
Interventions/Control_2
Consume the placebo food for 4 weeks, followed by the test food for another 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy male and female adults aged 20 years or older and under 65 years at the time of obtaining informed consent
2. Individuals who report dissatisfaction with their sleep
3. Individuals who sleep alone at bedtime
4. Individuals who have been informed of the purpose and details of the study, possess the capacity to provide consent, thoroughly understand the information, and voluntarily provide their consent via electronic informed consent
Key exclusion criteria
Individuals:
1.With sleep or psychiatric disorders under treatment or with a history of severe illness
2.With chronic diseases under medical treatment
3.With a history of or receiving treatment for serious cardiovascular, cerebrovascular, hepatic, renal, hematologic, or endocrine disorders
4.With gastrointestinal disorders under treatment or with a history of severe illness
5.With significant abnormalities in vitals, blood tests, or physical examination during the pre-screening
6.With past adverse reactions after blood collection
7.Suspected of having allergic reactions to the test food
8.With pacemakers or implantable cardioverter defibrillators
9.With a history of skin problems caused by alcohol disinfectants or adhesive tapes
10.Experiencing nocturia
11.Who may have blood contamination in their saliva samples
12.Who have recently donated blood or cannot refrain from donating blood during the study period
13.Regularly using medications, specified health foods, or nutraceuticals that may improve or inhibit sleepiness before bedtime
14.Regularly using medications that may affect bowel movements
15.Regularly consuming specific health foods (other than those affecting sleepiness) and who cannot discontinue these during the study period
16.Regularly consuming fermented milk or probiotic beverages and who cannot discontinue intake during the study period
17-19.Regular alcohol consumers, current smokers or those who have quit within the past 3 months, and those with irregular sleep or eating habits
20.Expected to undergo significant changes in living environment, dietary habits, or exercise routines during the study period
21.Women who are breastfeeding, pregnant, possibly pregnant, or intending to become pregnant during the study period
22.Currently participating in other clinical trials, participated within the past 4 weeks, or planning to participate during the study period
23.Deemed ineligible by the principal investigator
Target sample size
126
Research contact person
Name of lead principal investigator
| 1st name | Soma |
| Middle name | |
| Last name | Ode |
Organization
Macromill, Inc.
Division name
Clinical Trial Unit, Life Science Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo Japan
TEL
03-6716-0700
ohde@macromill.com
Public contact
Name of contact person
| 1st name | Ayumi |
| Middle name | |
| Last name | Sugioka |
Organization
Macromill, Inc.
Division name
Clinical Trial Unit, Life Science Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan
TEL
03-6716-0700
Homepage URL
sugioka@macromill.com
Sponsor or person
Institute
Macromill, Inc.
Institute
Department
Personal name
Funding Source
Organization
Nissin York 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
Ethical Committee of Kobuna Orthopedics Clinic
Address
311-2 Joto-machi, Maebashi-shi, Gumma
Tel
027-212-5608
sagawa@mc-connect.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
医療法人財団同仁記念会 明和病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 03 | 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 | 05 | Month | 29 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 24 | 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 | 06 | Month | 02 | Day |
Last modified on
| 2025 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066271
