UMIN-CTR Clinical Trial

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
Key secondary outcomes	Questionnaires related to menopausal symptoms

Base
Study type	Interventional

Study design
Basic design	Parallel
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	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Secoisolariciresinol diglucoside (SDG) low dose capsule (2 capsules per day)
Interventions/Control_2	Secoisolariciresinol diglucoside (SDG) high dose capsule (2 capsules per day)
Interventions/Control_3	Placebo food (2 capsules per day)
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 (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.
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 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.
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Rumiko Middle name Last name Miyashita
Organization	NIPPN CORPORATION
Division name	Innovation Center, Central Research Laboratory
Zip code	243-0041
Address	5-1-3 Midorigaoka, Atsugi City, Kanagawa Prefecture
TEL	042-222-6963
Email	miyashita@nippn.co.jp

Public contact
Name of contact person	1st name Tadashi Middle name Last name Nishikawara
Organization	Macromill, Inc.
Division name	Secretariat "Evaluation test for menopausal symptom improvement by flax lignan
Zip code	108-0075
Address	F11, Shinagawa East One Tower, 2-16-1, konan, Minato-ku, Tokyo
TEL	0120-998-017
Homepage URL
Email	monitor@terra-k.co.jp

Sponsor
Institute	Macromill, Inc.
Institute
Department

Funding Source
Organization	NIPPN CORPORATION
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, 2-7-5 Higashiueno, Taito-ku, Tokyo
Tel	03-6240-1162
Email	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	2022 Year 06 Month 19 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	Terminated
Date of protocol fixation	2022 Year 04 Month 13 Day
Date of IRB	2022 Year 04 Month 12 Day
Anticipated trial start date	2022 Year 06 Month 14 Day
Last follow-up date	2022 Year 09 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 04 Month 22 Day
Last modified on	2022 Year 10 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054236