Unique ID issued by UMIN | UMIN000047557 |
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Receipt number | R000054236 |
Scientific Title | Evaluation of the effect of flaxseed lignan on menopausal symptoms |
Date of disclosure of the study information | 2022/06/19 |
Last modified on | 2022/10/24 10:38:25 |
Evaluation of the effect of flaxseed lignan on menopausal symptoms
Evaluation of the effect of flaxseed lignan on menopausal symptoms
Evaluation of the effect of flaxseed lignan on menopausal symptoms
Evaluation of the effect of flaxseed lignan on menopausal symptoms
Japan |
healthy person
Adult |
Others
NO
To examine the effect of continuous intake of flaxseed lignan (secoisolariciresinol diglucoside: SDG) on menopausal symptoms.
Efficacy
The simplified menopausal index (SMI) test
Questionnaires related to menopausal symptoms
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
3
Prevention
Food |
Secoisolariciresinol diglucoside (SDG) low dose capsule (2 capsules per day)
Secoisolariciresinol diglucoside (SDG) high dose capsule (2 capsules per day)
Placebo food (2 capsules per day)
35 | years-old | <= |
60 | years-old | >= |
Female
(1) Females between the ages of 35-60 years at the time of consent.
(2) Those who are able to consume the test meal continuously.
(3) Those who are in the transitional period (less than 3 years from the last menstrual period) or after menopause (less than 3 years from the last menstrual period).
(4) Those who have subjective symptoms related to menopause
(5) Simplified Menopausal Index (SMI): 26 points or more.
(6) Those who can avoid binge drinking and excessive exercise during the study period and lead the same lifestyle (diet, exercise, etc.) as before the study period.
(7) Those who have received sufficient explanation of the purpose and content of this study, have the ability to consent, and can voluntarily volunteer to participate with a good understanding of the study, and agree to participate in this study in writing.
(8) Those who receive no medication.
(1) Those who have food allergy.
(2) Those who are pregnant or lactating, or plan to become pregnant or lactate during the study.
(3) Those who have participated in other clinical studies within 3 months of consent and those who plan to participate in other clinical studies during the study period.
(4) Those who have undergone oophorectomy or hysterectomy.
(5) Those with extremely irregular diets or irregular sleep rhythms (e.g., Night and day shift worker).
(6) Those who regularly use medicines, food for specified health use, functional food, or health food that may affect the evaluation items.
(7) Those who have been taking hormone therapy.
(8) Those who excessively smoke or excessively consume alcohol.
(9) Those who are undergoing treatment for a disease, or have a history of a serious disease that required medication.
(10) Patients with serious diseases such as diabetes, hepatic disease, renal disease, or cardiac disease, or those with a history of such diseases.
(11) Those who are judged to be inappropriate as subjects based on the answers to various questionnaires.
(12) Others, who are judged by the principal investigator to be inappropriate as subjects.
150
1st name | Rumiko |
Middle name | |
Last name | Miyashita |
NIPPN CORPORATION
Innovation Center, Central Research Laboratory
243-0041
5-1-3 Midorigaoka, Atsugi City, Kanagawa Prefecture
042-222-6963
miyashita@nippn.co.jp
1st name | Tadashi |
Middle name | |
Last name | Nishikawara |
Macromill, Inc.
Secretariat "Evaluation test for menopausal symptom improvement by flax lignan
108-0075
F11, Shinagawa East One Tower, 2-16-1, konan, Minato-ku, Tokyo
0120-998-017
monitor@terra-k.co.jp
Macromill, Inc.
NIPPN CORPORATION
Profit organization
Ueno-Asagao Clinic Ethical Review Committee
6F, 2-7-5 Higashiueno, Taito-ku, Tokyo
03-6240-1162
jimukyoku@tes-h.co.jp
NO
2022 | Year | 06 | Month | 19 | Day |
Unpublished
Terminated
2022 | Year | 04 | Month | 13 | Day |
2022 | Year | 04 | Month | 12 | Day |
2022 | Year | 06 | Month | 14 | Day |
2022 | Year | 09 | Month | 19 | Day |
2022 | Year | 04 | Month | 22 | Day |
2022 | Year | 10 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054236
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