UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051825 |
|---|---|
| Receipt number | R000059143 |
| Scientific Title | Evaluation of the effect of flaxseed lignan on menopausal symptoms |
| Date of disclosure of the study information | 2023/09/11 |
| Last modified on | 2024/08/09 15:50:57 |
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Basic information
Public title
Evaluation of the effect of flaxseed lignan on menopausal symptoms
Acronym
Evaluation of the effect of flaxseed lignan on menopausal symptoms
Scientific Title
Evaluation of the effect of flaxseed lignan on menopausal symptoms
Scientific Title:Acronym
Evaluation of the effect of flaxseed lignan on menopausal symptoms
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of continuous intake of flaxseed lignan (secoisolariciresinol diglucoside: SDG) on menopausal symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The simplified menopausal index (SMI) test
Pittsburgh sleep quality index
Key secondary outcomes
Questionnaires related to menopausal symptoms
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
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
Secoisolariciresinol diglucoside (SDG) capsule (4 capsules per day)
Interventions/Control_2
Placebo capsule (4 capsules per day)
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
| 35 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
(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 (irregular menstruation in the last year) 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.
Key exclusion criteria
(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 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.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Fukumitsu |
Organization
NIPPN CORPORATION
Division name
Innovation Center, Central Research Laboratory
Zip code
2430041
Address
5-1-3 Midorigaoka, Atsugi City, Kanagawa Prefecture
TEL
042-222-6963
sfukumitsu@nippn.co.jp
Public contact
Name of contact person
| 1st name | Soma |
| Middle name | |
| Last name | Ode |
Organization
Macromill, Inc.
Division name
Secretariat "Evaluation test for menopausal symptom improvement by flax lignan"
Zip code
1080075
Address
F11, Shinagawa East One Tower, 2-16-1, konan, Minato-ku, Tokyo
TEL
0120-998-017
Homepage URL
monitor@terra-k.co.jp
Sponsor or person
Institute
Macromill, Inc.
Institute
Department
Personal name
Funding Source
Organization
NIPPN CORPORATION
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ueno-Asagao Clinic Ethical Review Committee
Address
6F, 2-7-5 Higashiueno, Taito-ku, Tokyo
Tel
03-6240-1162
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 | 09 | Month | 11 | 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
120
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
Completed
Date of protocol fixation
| 2023 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 08 | 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 | 08 | Month | 04 | Day |
Last modified on
| 2024 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059143
