Unique ID issued by UMIN | UMIN000055070 |
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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 |
A study to examine the effect of triple organic acid magnesium intake on menstrual symptoms in healthy adult women
A study to examine the effect of triple organic acid magnesium intake on menstrual symptoms in healthy adult women
A study to examine the effect of triple organic acid magnesium intake on menstrual symptoms in healthy adult women
A study to examine the effect of triple organic acid magnesium intake on menstrual symptoms in healthy adult women
Japan |
Healthy subjects
Not applicable |
Others
NO
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.
Efficacy
Menstrual Distress Questionnaire (MDQ) score
Menstrual pain VAS questionnaire, POMS2 short version
Interventional
Cross-over
Randomized
Cluster
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Intake of active food for 4 weeks - Washout period (more than4 weeks) - Intake of placebo food for 4 weeks
Intake of placebo food for 4 weeks - Washout period (more than4 weeks) - Intake of active food for 4 weeks
25 | years-old | <= |
40 | years-old | > |
Female
"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."
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.
32
1st name | Daisuke |
Middle name | |
Last name | Ochitani |
BHN Co., Ltd
EBF Business Promotion Office
101-0054
1-16, Kanda Nishiki-cho, Chiyoda-ku, Tokyo, 101-0054, Japan
03-5281-5661
d-ochitani@bhn.co.jp
1st name | Masao |
Middle name | |
Last name | Matsuoka |
M&I Science CORP.
Clinical Development Department
531-0001
Pacific Marks Nishi Umeda 4F, 2-6-60 Umeda, Kita-ku, Osaka City, Osaka, Japan
06-7878-6780
m.matsuoka@mis21.co.jp
BHN Co., Ltd
Tateho Chemical Industries Co., Ltd.
Profit organization
Ethics Review Committee, Tokyo Shinjuku Clinic, Daifukukukai Medical Corporation
SIL Shinjuku Bldg. 5F, 2-46-3 Kabukicho, Shinjuku-ku, Tokyo, Japan
03-6709-6071
irb@ml.taifukukai.jp
NO
2024 | Year | 07 | Month | 25 | Day |
Unpublished
Preinitiation
2024 | Year | 07 | Month | 08 | Day |
2024 | Year | 07 | Month | 19 | Day |
2024 | Year | 09 | Month | 24 | Day |
2025 | Year | 03 | Month | 01 | Day |
(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.
2024 | Year | 07 | Month | 25 | Day |
2024 | Year | 07 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062912
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