UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054186 |
|---|---|
| Receipt number | R000061877 |
| Scientific Title | Effects of consumption of the test food on perimenstrual symptoms in healthy female college students: a double-blind, placebo-controlled, crossover comparison trial |
| Date of disclosure of the study information | 2025/12/16 |
| Last modified on | 2024/04/26 14:44:30 |
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Basic information
Public title
Effects of consumption of the test food on perimenstrual symptoms in healthy female college students
Acronym
Effects of consumption of the test food on perimenstrual symptoms in healthy female college students
Scientific Title
Effects of consumption of the test food on perimenstrual symptoms in healthy female college students: a double-blind, placebo-controlled, crossover comparison trial
Scientific Title:Acronym
Effects of consumption of the test food on perimenstrual symptoms in healthy female college students
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of consumption of the test food on perimenstrual symptoms in healthy female college students
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Perimenstrual symptoms questionnaire
Key secondary outcomes
Basal body temperature
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Daily intake of test food for 2 menstrual cycles -> Washout for 1 menstrual cycle -> Daily intake of placebo food for 2 menstrual cycles
Interventions/Control_2
Daily intake of placebo food for 2 menstrual cycles -> Washout for 1 menstrual cycle -> Daily intake of test food for 2 menstrual cycles
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Subjects who are healthy female students aged 18 or more
2) Subjects who have any physical or psychological symptoms during pre-menstruation
3) Subjects who are receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being to personally sign a written informed consent
Key exclusion criteria
1) Subjects who are allergic to the test food
2) Subjects who are having serious disorders
3) Subjects who are undergoing medical treatment of gynecological such as premenstrual symptoms and premenstrual dysphoric disorder, or mental diseases
4) Subjects who are constantly taking medicines for gynecological diseases such as low dose pill and herbal medicines
5) Subjects who are constantly taking supplements that attenuating premenstrual symptoms
6) Subjects who are pregnant or lactating, or intending to become pregnant during the study
7) Subjects whose menstrual cycle is not within the range of 25 to 38 days
8) Subjects who are currently taking part in another clinical studies
9) Subjects who are judged as ineligible to participate in this study by the principal investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Sayo |
| Middle name | |
| Last name | Uesugi |
Organization
Otsuma Women's University
Division name
Department of Food Science, Faculty of Home Economics
Zip code
102-8357
Address
3-12 Chiyoda-ku, Tokyo
TEL
03-5275-6066
sues@otsuma.ac.jp
Public contact
Name of contact person
| 1st name | Chisato |
| Middle name | |
| Last name | Aiso |
Organization
Fujicco Co., Ltd.
Division name
Innovation center
Zip code
650-8558
Address
6-13-4 Minatojima-Nakamachi, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-303-5385
Homepage URL
c-aiso@fujicco.co.jp
Sponsor or person
Institute
Otsuma Women's University
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
Naoko Ishiwata (Department of Life Environments Management, Atomi University)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical review committee of Otsuma Women's University
Address
3-12 Chiyoda-ku, Tokyo
Tel
03-5275-6000
kenkyu.s@ml.otsuma.ac.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
| 2025 | Year | 12 | Month | 16 | 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
| 2024 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 18 | Day |
Last modified on
| 2024 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061877
