UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049422 |
|---|---|
| Receipt number | R000056277 |
| Scientific Title | Observational study of the association between Premenstrual Syndrome (PMS) and intakes of food group/nutrients |
| Date of disclosure of the study information | 2022/11/07 |
| Last modified on | 2023/05/23 11:00:18 |
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Basic information
Public title
Observational study of the associations between Premenstrual Syndrome (PMS) and intakes of food group/nutrients
Acronym
Study of association between PMS and intakes of food group/nutrients
Scientific Title
Observational study of the association between Premenstrual Syndrome (PMS) and intakes of food group/nutrients
Scientific Title:Acronym
Study of association between PMS and intakes of food group/nutrients
Region
| Japan |
Condition
Condition
Premenstrual Syndrome (PMS)
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify associations between Premenstrual Syndrome and intakes of food group/nutrients
Basic objectives2
Others
Basic objectives -Others
Association between PMS and dietary habits
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Association between PMS and intakes of food group/nutrients
Key secondary outcomes
1) Association between PMS and physical activity
2) Association between PMS and background information.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 39 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Employees of AJINOMOTO CO., INC. (Includes seconded employees and excludes part-time and temporary employees)
2. Females aged 18-39 years at the time of informed consent
3. Subjects who have given written consent to participate in the study by voluntary agreement
Key exclusion criteria
Pregnant at the time of informed consent
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Yoji |
| Middle name | |
| Last name | Yamada |
Organization
AJINOMOTO CO., INC.
Division name
Institute of Food Sciences and Technologies
Zip code
210-8681
Address
1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa, Japan
TEL
+81-044-210-5844
youji.yamada.wn9@asv.ajinomoto.com
Public contact
Name of contact person
| 1st name | Kotono |
| Middle name | |
| Last name | Kobayashi |
Organization
AJINOMOTO CO., INC.
Division name
Institute of Food Sciences and Technologies
Zip code
210-8681
Address
1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa, Japan
TEL
+81-044-210-5844
Homepage URL
kotono.kobayashi.bt6@asv.ajinomoto.com
Sponsor or person
Institute
AJINOMOTO CO., INC.
Institute
Department
Personal name
Funding Source
Organization
AJINOMOTO CO., INC.
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
The Ethics Committee of Ajinomoto Co., Inc.
Address
1-15-1, Kyobashi, Chuo-ku, Tokyo, Japan
Tel
+81-3-5250-8111
ajinomoto_irb@asv.ajinomoto.com
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
味の素株式会社(AJINOMOTO CO., INC.)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 07 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design is cross sectional study.
Recruitment period is November 7 to November 27 in 2022.
Management information
Registered date
| 2022 | Year | 11 | Month | 04 | Day |
Last modified on
| 2023 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056277
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
