UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062300 |
|---|---|
| Receipt number | R000071185 |
| Scientific Title | A Study on the Effects of Continuous Intake of the Test Food on sleep quality in menopausal women: A randomized, double-blind, placebo-controlled, parallel-group study |
| Date of disclosure of the study information | 2026/07/22 |
| Last modified on | 2026/07/22 11:18:23 |
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Basic information
Public title
A Study on the Effects of Continuous Intake of the Test Food on sleep quality in menopausal women
Acronym
A Study on the Effects of Continuous Intake of the Test Food on sleep quality in menopausal women
Scientific Title
A Study on the Effects of Continuous Intake of the Test Food on sleep quality in menopausal women: A randomized, double-blind, placebo-controlled, parallel-group study
Scientific Title:Acronym
A Study on the Effects of Continuous Intake of the Test Food on sleep quality in menopausal women: A randomized, double-blind, placebo-controlled, parallel-group study
Region
| Japan |
Condition
Condition
Healthy participants
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of 12-week continuous intake of the test food on sleep quality in healthy Japanese women aged 40 to 64 years who are dissatisfied with their sleep quality through a randomized, double-blind, placebo-controlled, parallel-group study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
(1) Actual values of sleep time in Oguri-Shirakawa-Azumi Sleep Questionnaire MA version (OSA-MA) after 12 weeks of intake
Key secondary outcomes
(1) Actual values of sleep time in OSA-MA after 6 weeks of intake
(2) Change and rate of change from baseline in sleep time in OSA-MA after 6 and 12 weeks of intake
(3) Actual values, change, and rate of change from baseline in sleepiness on rising, initiation and maintenance of sleep, frequent dreaming, recovery from fatigue, and each question item in OSA-MA after 6 and 12 weeks of intake
(4) Actual values, change, and rate of change from baseline in total score and vasomotor, mental, and physical nervous symptoms, and each question item in Simplified Menopausal Index (SMI) after 12 weeks of intake
(5) Actual values, change, and rate of change from baseline in TMD score, TA, DD, AH, VA, FI, CB, F, and each question item in Profile of Mood States 2nd Edition (POMS-2) Adult Short Form after 12 weeks of intake
(6) Actual values, change, and rate of change from baseline in Visual Analog Scale (VAS) (shoulder discomfort, lower back discomfort, eye fatigue) after 6 and 12 weeks of intake
(7) Urinary equol concentration after isoflavone intake and its change from baseline after 12 weeks of intake
(8) Number of equol producers and its change from baseline after 12 weeks of intake
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
NO
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
| 64 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Healthy Japanese women aged 40 to 64 years.
(2) Individuals who had menstruation within the past 1 year and are irregular or less than 5 years postmenopausal.
(3) Individuals whose total score of Simplified Menopausal Index (SMI) is 50 or less.
(4) Individuals who are dissatisfied with their sleep quality.
(5) Individuals who feel temporary discomfort such as shoulder pain.
(6) Individuals who have received sufficient explanation regarding the purpose and contents of this study, have the capacity to consent, fully understand, volunteer of their own free will, and provide electronic informed consent.
(7) Individuals judged by the principal investigator to have no problems participating in the study based on the interview during the pre-observation period.
(8) Among those who meet the criteria (1) to (7) above and do not meet the exclusion criteria, those who have lower scores for sleep time in the OSA sleep questionnaire during the web-screening and pre-observation period.
Key exclusion criteria
(1) History/treatment of mental illness, sleep apnea, hypersomnia, narcolepsy, insomnia, or valvular heart disease.
(2) History/treatment of malignancy, cerebrovascular, heart, liver, kidney, hematologic, or endocrine disease.
(3) Undergoing treatment for gynecological diseases (e.g., menopausal disorders, dysmenorrhea).
(4) History of oophorectomy or hysterectomy.
(5) History/treatment of gastrointestinal disease (e.g., gastrectomy, resection; excluding appendectomy alone).
(6) Subjective sleep disorder symptoms (snoring, daytime sleepiness, choking, gasping, insomnia, or witnessed apnea).
(7) Nocturia disrupting sleep.
(8) Having an infant under 1 year old at home.
(9) Bed-sharing with a toddler.
(10) Living with and caring for a person requiring nursing care.
(11) Sharing bedding with others.
(12) Over 5 years postmenopausal.
(13) Lactating, pregnant, possibly pregnant, or planning pregnancy during the study.
(14) Receiving hormone replacement therapy.
(15) Regular use of oral contraceptives or Kampo medicine.
(16) Regular use of supplements for menopausal relief (e.g., equol).
(17) Regular use of supplements/foods/beverages for fatigue, stress, sleep, joint discomfort, or eye strain.
(18) Daily soy isoflavone intake of 50 mg or more.
(19) Treatment/medication for chronic diseases affecting study results.
(20) Current smoker.
(21) Quit smoking within 3 months before informed consent.
(22) Habitual alcohol drinker.
(23) Extremely irregular sleep or dietary habits.
(24) Expected major changes in environment, diet, or exercise during the study.
(25) Potential allergy to the study food.
(26) Current, recent (within 4 weeks), or planned participation in other clinical trials.
(27) Otherwise judged ineligible by the principal investigator.
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Soma |
| Middle name | |
| Last name | Ode |
Organization
Macromill Carenet, Inc.
Division name
Clinical Research Solution Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan
TEL
03-6716-7108
umin_info@macromillcarenet.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Kimoto |
Organization
Macromill Carenet, Inc.
Division name
Clinical Research Solution Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan
TEL
03-6716-7108
Homepage URL
umin_info@macromillcarenet.jp
Sponsor or person
Institute
Macromill Carenet, Inc.
Institute
Department
Personal name
Funding Source
Organization
FUJICCO 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
医療法人公雄会こぶな整形外科医院倫理審査委員会
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 22 | 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 | 07 | Month | 09 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 15 | 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 | 07 | Month | 22 | Day |
Last modified on
| 2026 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071185
