UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060924 |
|---|---|
| Receipt number | R000069700 |
| Scientific Title | Effects of test food intake on quality of life (QOL) in healthy middle-aged women: A randomized, double-blind, placebo-controlled, parallel-group study |
| Date of disclosure of the study information | 2026/03/13 |
| Last modified on | 2026/03/13 14:25:22 |
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Basic information
Public title
Effects of test food intake on quality of life (QOL) in healthy middle-aged women
Acronym
Effects of test food intake on quality of life (QOL) in healthy middle-aged women
Scientific Title
Effects of test food intake on quality of life (QOL) in healthy middle-aged women: A randomized, double-blind, placebo-controlled, parallel-group study
Scientific Title:Acronym
Effects of test food intake on quality of life (QOL) in healthy middle-aged women
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of test food intake on improving the quality of life (QOL) among healthy Japanese women aged between 40 and 64 years.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Actual values in the SMI (Simplified Menopausal Index) total score at 4 weeks after the start of intervention
Key secondary outcomes
1. Change from baseline in the SMI total score at 4 weeks after the start of intervention.
2. Actual values and change from baseline in hot flash Visual Analogue Scale (VAS) scores at 4 weeks after the start of intervention.
3. Actual values and change from baseline in each of the 10 item scores of the SMI at 4 weeks after the start of intervention. Items include:(1) hot flashes, (2) sweating, (3) coldness in extremities, (4) palpitations, (5) insomnia, (6) irritability, (7) depression, (8) headaches/dizziness, (9) fatigue, and (10) joint/muscle pain.
4. Composite hot flash score from baseline to week 4 of the intervention.
5. Actual values and change from baseline in the PSQI-j (Japanese version of the Pittsburgh Sleep Quality Index) global score and its 7 component scores at 4 weeks after the start of intervention.
Components include:(1) sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbances, (6) use of sleeping medication, and (7) daytime dysfunction.
6. Actual values and change from baseline in the POMS 2 (Profile of Mood States 2nd Edition) adult short form TMD score and its 7 subscale scores at 4 weeks after the start of intervention.
Subscales include:(1) Anger-Hostility, (2) Confusion-Bewilderment, (3) Depression-Dejection, (4) Fatigue-Inertia, (5) Tension-Anxiety, (6) Vigor-Activity, and (7) Friendliness.
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of 100 mg of the test food for 4 weeks
Interventions/Control_2
Intake of 300 mg of the test food for 4 weeks
Interventions/Control_3
Intake of the placebo food for 4 weeks
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
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
1. Japanese
2. Female aged 40 to 64 years
3. Healthy individuals
4. Individuals with a SMI total score between 26 and 50
5. Individuals who perceive temporary hot flashes
Key exclusion criteria
1. Diagnosed with or suspected of menopausal/climacteric disorder by a physician
2. History or presence of serious diseases (e.g., malignant tumor, heart failure, or myocardial infarction)
3. Use of a pacemaker or implantable cardioverter defibrillator (ICD)
4. History or presence of chronic diseases (e.g., cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia,hypertension, or any other chronic diseases)
5. Habitual use of health foods, dietary supplements (e.g., GABA, equol, or soy isoflavones), or medications (e.g., Kampo medicines such as Keishibukuryogan or Kamishoyosan) that may affect menopausal symptoms
6. Allergic to medicines or ingredients related to the test product
7. BMI < 18.5 kg/m2 or >= 25.0 kg/m2
8. Heavy drinkers (average pure alcohol intake >= 60 g/day)
9. Excessive caffeine intake ( >= 500 mg/day)
10. Heavy smokers ( >= 20 cigarettes/ day or Brinkman Index >=400)
11. Extremely irregular lifestyle rhythms due to night shifts, shift work, or other reasons
12. Undergoing exercise or alimentary therapy under medical supervision
13. History or presence of drug or alcohol dependence
14. History or presence of psychiatric/sleep disorders (e.g., depression, insomnia, sleep apnea syndrome)
15. Pregnant, lactating, or planning to become pregnant during this study
16. Enrolled in other clinical trials within 28 days prior to consent, or planning to participate in another study
17. Judged ineligible to participate in this study based on measurement values at screening
18. Judged ineligible to participate in this study by the physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kazuya |
| Middle name | |
| Last name | Watabe |
Organization
Pharma Foods International Co., Ltd.
Division name
R&D Department
Zip code
615-8245
Address
1-49 Goryo-Ohara, Nishikyo-ku, Kyoto, Japan
TEL
075-748-9829
watabe@pharmafoods.co.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Miyazawa |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0023
Address
NAKANO SPRING Bldg 5F, 4-11-17 Shibaura, Minato-ku, Tokyo, Japan
TEL
03-3431-1260
Homepage URL
rd@huma-rd.co.jp
Sponsor or person
Institute
Pharma Foods International Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Pharma Foods International 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 Corporation DiaStep Ouchinodoctor Research Ethics Committee
Address
Morizumi Bldg. 3F, 4-22-7 Taishido, Setagaya-ku, Tokyo, Japan
Tel
03-5433-3255
tomohisa.kato@diastep.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
| 2026 | Year | 03 | Month | 13 | 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 | 02 | Month | 19 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 13 | 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 | 03 | Month | 13 | Day |
Last modified on
| 2026 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069700
