UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000055070 |
|---|---|
| Receipt number | R000062912 |
| Scientific Title | A study to examine the effect of triple organic acid magnesium intake on menstrual symptoms in healthy adult women |
| Date of disclosure of the study information | 2024/07/25 |
| Last modified on | 2024/07/25 11:56:18 |
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Basic information
Public title
A study to examine the effect of triple organic acid magnesium intake on menstrual symptoms in healthy adult women
Acronym
A study to examine the effect of triple organic acid magnesium intake on menstrual symptoms in healthy adult women
Scientific Title
A study to examine the effect of triple organic acid magnesium intake on menstrual symptoms in healthy adult women
Scientific Title:Acronym
A study to examine the effect of triple organic acid magnesium intake on menstrual symptoms in healthy adult women
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to confirm the effect of ingestion of test foods on menstrual symptoms in Japanese women aged 25 to 40 years with normal menstrual cycles.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Menstrual Distress Questionnaire (MDQ) score
Key secondary outcomes
Menstrual pain VAS questionnaire, POMS2 short version
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
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
Intake of active food for 4 weeks - Washout period (more than4 weeks) - Intake of placebo food for 4 weeks
Interventions/Control_2
Intake of placebo food for 4 weeks - Washout period (more than4 weeks) - Intake of active food for 4 weeks
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
| 25 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
"1. Japanese women aged 25 to 40 years at the time of obtaining written informed consent, with normal menstrual cycles (25-38 days)
2. Subjects who experience menstrual symptoms from 5 days before the start of menstruation to around the third day of menstruation
3. Subjects whose MDQ score is higher before menstruation than during menstruation
4. Subjects who have been fully explained the purpose and contents of the study, are capable of consenting, fully understand the content, and voluntarily volunteer to participate in the study and agree to participate in the study in writing."
Key exclusion criteria
1. Individuals who have been diagnosed by a doctor with a gynecological disease {premenstrual syndrome (PMS), premenstrual dysphoric disorder (PMDD), secondary amenorrhea, menorrhagia, dysmenorrhea, endometriosis, uterine fibroids, breast cancer, cervical cancer, uterine cancer, ovarian cancer, etc.]
2. Individuals currently undergoing medication or outpatient treatment for any serious disease
3. Individuals currently undergoing exercise or diet therapy under the supervision of a doctor
4. Individuals at risk of developing an allergy to the test food
5. Individuals with a current or past history of drug or alcohol dependence
6. Individuals currently undergoing outpatient treatment for a mental disorder (depression, etc.) or sleep disorder (insomnia, sleep apnea syndrome, etc.), or individuals with a history of a mental disorder in the past
7. Individuals with irregular lifestyles due to night shifts or shift work, etc.
8. Individuals with extremely irregular lifestyles, such as eating and sleeping habits
9. Individuals with extremely unbalanced diets
10. Individuals with serious current or past illnesses, such as brain disease, malignant tumors, immune diseases, diabetes, liver disease (hepatitis), kidney disease, heart disease, thyroid disease, adrenal disease, and other metabolic diseases
11. Individuals using health foods, supplements, and medicines (such as low-dose birth control pills) that affect menstrual symptoms
12. Individuals who have participated in other clinical trials (research) within the three months prior to the date of consent acquisition, or who plan to participate in other clinical trials (research) during the study period
13. Individuals who have consumed 200 mL or 400 mL of ethanol within one month prior to the date of consent acquisition, or who have consumed 50 mL or 100 mL of ethanol within three months prior to the date of consent acquisitionThose who have drawn more than 100 mL of blood or donated blood components.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Ochitani |
Organization
BHN Co., Ltd
Division name
EBF Business Promotion Office
Zip code
101-0054
Address
1-16, Kanda Nishiki-cho, Chiyoda-ku, Tokyo, 101-0054, Japan
TEL
03-5281-5661
d-ochitani@bhn.co.jp
Public contact
Name of contact person
| 1st name | Masao |
| Middle name | |
| Last name | Matsuoka |
Organization
M&I Science CORP.
Division name
Clinical Development Department
Zip code
531-0001
Address
Pacific Marks Nishi Umeda 4F, 2-6-60 Umeda, Kita-ku, Osaka City, Osaka, Japan
TEL
06-7878-6780
Homepage URL
m.matsuoka@mis21.co.jp
Sponsor or person
Institute
BHN Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Tateho Chemical Industries 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
Ethics Review Committee, Tokyo Shinjuku Clinic, Daifukukukai Medical Corporation
Address
SIL Shinjuku Bldg. 5F, 2-46-3 Kabukicho, Shinjuku-ku, Tokyo, Japan
Tel
03-6709-6071
irb@ml.taifukukai.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
| 2024 | Year | 07 | Month | 25 | 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 | 07 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Exclusion criteria continued)
14. Those who are currently pregnant or breastfeeding, or may become pregnant or breastfeed during the study period.
15. Those who have difficulty completing the various survey forms.
16. Those who are deemed unsuitable as subjects based on slinical test values and measurements at the time of SCR.
17. Those who are otherwise deemed unsuitable as subjects by the principal investigator.
Management information
Registered date
| 2024 | Year | 07 | Month | 25 | Day |
Last modified on
| 2024 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062912
| 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 |
