UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059395 |
|---|---|
| Receipt number | R000067927 |
| Scientific Title | The Effects of Consumption of Test Foods on Women's Health Condition -A Placebo-Controlled Randomized Double-Blind Parallel-Group Comparative Trial- |
| Date of disclosure of the study information | 2026/10/14 |
| Last modified on | 2026/07/06 10:31:58 |
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Basic information
Public title
The Effects of Consumption of Test Foods on Women's Health Condition -A Placebo-Controlled Randomized Double-Blind Parallel-Group Comparative Trial-
Acronym
The Effects of Consumption of Test Foods on Women's Health Condition
Scientific Title
The Effects of Consumption of Test Foods on Women's Health Condition -A Placebo-Controlled Randomized Double-Blind Parallel-Group Comparative Trial-
Scientific Title:Acronym
The Effects of Consumption of Test Foods on Women's Health Condition
Region
| Japan |
Condition
Condition
Healthy female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the effects of consuming test foods on health status
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Women's Health Questionnaire
Key secondary outcomes
VAS Questionnaire
Survey on Activities
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
Take two test food tablets per day
Interventions/Control_2
Take two placebo food tablets per day
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
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Age from 20 to 45, at the time of obtaining consent to participate in the trial
(2) Healthy Japanese women
(3) Subjects with a normal menstrual cycle and a normal menstrual period
(4) Subjects who experience physical discomfort associated with their menstrual cycle, have premenstrual symptoms, and are aware that they often strongly experience symptoms during menstruation (such as various types of menstrual pain, fatigue, and emotional instability).
(5) Subjects who have received sufficient explanation regarding the purpose and content of this trial, possess the capacity to consent, fully understand the information, voluntarily participate of their own free will, and whose consent is obtained through electronic informed consent.
Key exclusion criteria
(1) Subjects with Gynecological disorders (PMS, PMDD, dysmenorrhea, menopausal disorders, hormone replacement therapy, uterine/ovarian/mammary gland disorders, etc.), psychiatric disorders (depression, anxiety disorders, insomnia, panic disorder, etc.), thyroid disorders (Graves' disease, Hashimoto's thyroiditis, etc.), autonomic nervous system disorders (autonomic imbalance, etc.), who are receiving treatment or medication from a physician, or who plan to receive treatment or medication during the trial period.
(2) Subjects with skin conditions (such as atopic dermatitis, skin allergy symptoms, eczema, or hypersensitivity) who are currently receiving treatment or medication from a physician, or who plan to receive treatment or medication during the trial period.
(3) Subjects with chronic conditions (such as anemia, perennial allergies, bronchial asthma, etc.) who are receiving treatment and medication from a physician.
(4) Subjects with a history of serious cerebrovascular disease, heart disease, liver disease, kidney disease, blood disorders, or endocrine disorders.
(5) Subjects with a history of serious digestive system diseases, such as gastrectomy, gastrointestinal anastomosis, or bowel resection (excluding those who have undergone appendectomy only).
(6) Subjects whom the responsible physician determines to have a mental disorder based on SDS scores.
(7) Subjects who have previously experienced discomfort or worsening health following blood draws.
(8) Subjects at risk of developing allergies to test foods.
(9) Subjects who donated 200 mL of whole blood within 4 weeks prior to the web screening test, or donated blood components within 2 weeks prior to the web screening test; or individuals who donated 400 mL of whole blood within 16 weeks prior to the web screening test.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Oikawa |
Organization
Comfo-Garden Clinic, Shokoukai
Division name
President
Zip code
162-0054
Address
3-2, Kawadacho, Shinjuku-ku, Tokyo, Japan
TEL
03-3357-0086
comfo-rinshou@synaps.co.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Mori |
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
03-6716-7108
Homepage URL
yuk_mori@macromillcarenet.jp
Sponsor or person
Institute
Macromill Carenet, Inc.
Institute
Department
Personal name
Funding Source
Organization
Asahi Quality & Innovations, 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
Institutional review board of Tsukiji Futaba Clinic.
Address
Tsukiji 1-9-9, Chuou-ku, Tokyo, Japan
Tel
03-6226-5812
tohru@hikobae.net
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 | 10 | Month | 14 | 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 | 10 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Exclusion criteria continued)
(10) Subjects who have undergone cosmetic procedures or treatments (such as collagen injections, hyaluronic acid injections, Botox injections, laser treatments, etc.) on the evaluation site within 12 weeks prior to the web screening test, or who are unable to refrain from cosmetic procedures or treatments during the study period.
(11) Subjects who are excessively sunburned, or who are unable to refrain from intentionally exposing themselves to direct sunlight during the examination period, such as by sunbathing..
(12) Subjects who cannot discontinue consumption of foods for specified health uses, foods with functional claims, or health foods during the trial period.
(13) Heavy smokers: Generally those who smoke 21 or more cigarettes per day.
(14) Subjects with excessive alcohol intake : Generally 60g or more of alcohol equivalent per day.
(15) Subjects with extremely irregular sleep habits or eating patterns (shift workers, night shift workers, etc.).
(16) Subjects whose living environment may undergo significant changes during the examination period, or whose dietary or exercise habits may undergo significant changes.
(17) Subjects who are breastfeeding, pregnant, or may be pregnant, or who intend to become pregnant during the trial period.
(18) Subjects currently participating in another clinical trial, or who participated within 4 weeks prior to the web screening test, or who plan to participate in another clinical trial during the study period.
(19) Subjects deemed ineligible as subjects by the responsible physician.
Management information
Registered date
| 2025 | Year | 10 | Month | 14 | Day |
Last modified on
| 2026 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067927
