UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052973 |
|---|---|
| Receipt number | R000060324 |
| Scientific Title | Effects of a Test Food for Improvement of Premenstrual Syndrome (PMS). |
| Date of disclosure of the study information | 2023/12/03 |
| Last modified on | 2024/01/19 09:57:39 |
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Basic information
Public title
Effects of a Test Food for Improvement of Premenstrual Syndrome (PMS).
Acronym
Effects of a Test Food for Improvement of Premenstrual Syndrome (PMS).
Scientific Title
Effects of a Test Food for Improvement of Premenstrual Syndrome (PMS).
Scientific Title:Acronym
Effects of a Test Food for Improvement of Premenstrual Syndrome (PMS).
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effect on premenstrual syndrome (PMS) of replacing the diet with the test food and having it consumed daily.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation index of premenstrual syndrome (PMS) symptom.
Key secondary outcomes
* Secondary indexes
1.Indexes on sleeping
2.Blood/saliva biomarker indicators
3.Indexes for body composition
4.Indexes on quality of life
* Exploratory endpoint
1.Physical and clinical examinations
2.Indexes on eating habit
*Safety indexes
1.Doctor's questions
2.Side effects and adverse events
3.Subject's diary
*Other indexes
1.Baseline characteristics
2.Height measurement
3.Dietary survey with Brief-type Self-Administered Diet History Questionnaire (BDHQ)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test food intake
(Two meals, lunch and dinner, shall be replaced with the test food and ingested daily.)
Interventions/Control_2
No test food intake
(Keeping normal eating habits.)
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) Healthy Japanese females aged 20-44 years.
2) Individuals with symptoms of premenstrual syndrome (PMS).
(Individuals who develop unfavorable mental or physical symptoms that last for 3 to 10 days before menstruation, and whose symptoms subside or disappear with the onset of menstruation.)
3) Individuals whose menstrual cycle is approximately 25 to 38 days and whose cycle fluctuation is within plus or minus 6 days
4) Individuals with regular lifestyle habits (ex. waking up time and bedtime).
5) Individuals whose written informed consent has been obtained.
6) Individuals who can visit an inspection facility and be inspected in designated days.
7) Individuals judged appropriate for the study by the principal.
Key exclusion criteria
1) Individuals using medical products.
2) Individuals who regularly use hormonal drugs such as pills or other drugs.
3) Individuals who are patient or have a history of psychiatric disease, sleep disorder, high blood pressure, diabetes and hyperlipidemia.
4) Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung, digestive system and hematological disease.
5) Individuals who used a drug to treat a disease in the past 1 month(except temporal usage for pollenosis).
6) Individuals who are sensitive to the test food.
7) Individuals who have difficulty continuing to consume the test food during the test period
8) Individuals with irregular eating habits (missing one of breakfast, lunch, or dinner) and unbalanced eating.
9) Individuals who drink excessive amounts of alcohol on a daily basis
10) Individuals who habitually take the foods for specified health uses or functional food.
11) Individuals who may change their lifestyle, or who may be unable to visit the test venue by job transfer or relocation.
12) Individuals who use a mobile phone that is not an iPhone on a daily basis, and who have difficulty wearing the provided Apple Watch all day during the test period, except bath time.
13) Individuals who have difficulty conducting basal body temperature measurements and surveys using Apple Watch and mobile apps, which is conducted every day during the test period.
14) Individuals who are unable to properly store or consume the test foods due to reasons such as inability of setting the distributed freezer or non-possession of a microwave oven.
15) Individuals who are or are possibly pregnant, or are lactating.
16) Individuals who participated in other clinical studies in the past 3 months.
17) Individuals who themselves or their families work at companies or research institutions that develop, manufacture, or sell health and functional foods.
18) Individuals judged inappropriate for the study by the principal.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Futoshi |
| Middle name | |
| Last name | Nakamura |
Organization
NISSIN FOODS HOLDINGS CO., LTD.
Division name
Future Food Research & Development Division
Zip code
192-0001
Address
2100 Tobukimachi, Hachioji-shi, Tokyo
TEL
+81-42-696-7606
futoshi.nakamura@nissin.com
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
NISSIN FOOD PRODUCTS CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
NISSIN FOOD PRODUCTS 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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 03 | 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
| 2023 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 05 | 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
| 2023 | Year | 12 | Month | 01 | Day |
Last modified on
| 2024 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060324
