UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062070 |
|---|---|
| Receipt number | R000071022 |
| Scientific Title | Effects of Continuous Intake of a Test Food on Subjective Sleep quality: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study |
| Date of disclosure of the study information | 2026/07/01 |
| Last modified on | 2026/06/26 15:44:37 |
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Basic information
Public title
Effects of Continuous Intake of a Test Food on Subjective Sleep quality: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study
Acronym
Effects of Continuous Intake of a Test Food on Subjective Sleep quality
Scientific Title
Effects of Continuous Intake of a Test Food on Subjective Sleep quality: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study
Scientific Title:Acronym
Effects of Continuous Intake of a Test Food on Subjective Sleep quality
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of 12-week continuous intake of the test food on subjective sleep quality in healthy men and women aged 40 to 59 years who are dissatisfied with their sleep quality.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
OSA Sleep Inventory MA version
Key secondary outcomes
St. Mary's Hospital Sleep Questionnaire
Pittsburgh Sleep Quality Index Japanese version
Subjective assessment questionnaire (NRS)
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Continuous intake of the test food for 12 weeks
Interventions/Control_2
Continuous intake of the placebo food for 12 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
| 40 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Men and women aged 40 to 59 years at consent.
(2) Aware of sleepiness or fatigue upon awakening, or poor sleep quality in daily life.
(3) Provided electronic informed consent with sufficient understanding of the study.
Key exclusion criteria
(1) History or current serious disease.
(2) Receiving treatment or medication for chronic diseases affecting study results.
(3) Disorders affecting the study (e.g., insomnia, overactive bladder, nocturia (2 or more times/night), depression, psychiatric or neurological disorders).
(4) Diagnosed with or suspected of having sleep apnea.
(5) Using drugs or supplements affecting study (e.g., sleep, fatigue, mood, menopause, autonomic nervous function).
(6) Current treatment or management for sleep disorders, fatigue, stress, or psychiatric disorders.
(7) Hormone use within 3 months before consent.
(8) Living or bedding conditions where sleep is disturbed by third parties (e.g., infants, preschool children, or care recipients).
(9) Night or shift work, or heavy labor within 2 months before consent, or planning to engage in such work during the study period.
(10) Average time in bed of less than 5 hours.
(11) Excessive alcohol or caffeine consumption, smoking, or BMI greater than 30.
(12) Risk of allergy related to the study foods.
(13) Risk of seasonal allergies interfering with sleep or daily life.
(14) Overseas travel within 2 weeks before consent or major lifestyle or sleep environment changes planned.
(15) Pregnant, lactating, or planning pregnancy.
(16) Treatment or medication for menopausal disorders or hot flashes.
(17) Inability to follow study procedures.
(18) Participation in other clinical studies within 1 month before consent or during the study.
(19) Judged inappropriate for participation by the investigator.
Target sample size
176
Research contact person
Name of lead principal investigator
| 1st name | Tomoki |
| Middle name | |
| Last name | Adachi |
Organization
FANCL CORPORATION
Division name
Research Institute
Zip code
244-0806
Address
12-13 Kamishinano, Totsuka-ku, Yokohama-shi, Kanagawa, 244-0806, Japan
TEL
045-820-3846
adachi_tomoki@fancl.co.jp
Public contact
Name of contact person
| 1st name | Ayumi |
| Middle name | |
| Last name | Sugioka |
Organization
Macromill Carenet, Inc.
Division name
Clinical Research Solution Department
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan
TEL
03-6716-0700
Homepage URL
umin_info@macromillcarenet.jp
Sponsor or person
Institute
Macromill Carenet , Inc.
Institute
Department
Personal name
Funding Source
Organization
FANCL CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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 Gokan-machi, Maebashi-shi, Gunma 371-0813, Japan
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
医療法人社団曙光会コンフォガーデンクリニック（東京都）/ Comfo-Garden Clinic, Medical Corporation Shokoukai
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 01 | 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
| 2026 | Year | 06 | Month | 11 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 26 | Day |
Last modified on
| 2026 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071022
