UMIN-CTR Clinical Trial

Basic information
Public title	Effects of lactic acid bacteria intake on perimenopausal men and women on menopause-like symptoms, sleep and biomarkers
Acronym	Effects of lactic acid bacteria intake on perimenopausal men and women on menopause-like symptoms, sleep and biomarkers
Scientific Title	Effects of lactic acid bacteria intake on perimenopausal men and women on menopause-like symptoms, sleep and biomarkers
Scientific Title:Acronym	Effects of lactic acid bacteria intake on perimenopausal men and women on menopause-like symptoms, sleep and biomarkers
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the effects of lactic acid bacteria on menopause-like symptoms, sleep and biomarkers after 8 consecutive weeks using placebo as a control.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Questionnaire about menopause (KKSI or AMS) at 8 weeks ingestion
Key secondary outcomes	1. Stiff shoulder VAS 2. Pittsburgh Sleep Quality Index (PSQI-j) 3. Cortisol 4. DHEA-S 5. Hot flash

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of test food for 8 consecutive weeks
Interventions/Control_2	Intake of placebo food for 8 consecutive 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	45 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Female older than 45 years and younger than 55 years, male older than 45 years (2) Subjects who are aware of aging irregular menstruation, indefinite complaints and poor sleep (3) Subjects judged to be healthy by a doctor
Key exclusion criteria	(1) Subjects who have passed more than one year after menopause (2) Subjects with history, treatment history, medication, or health food intake affecting the assessment of climacteric symptoms (3) Subjects with history, treatment history, medication, or health food consumption that affect sleep assessment (4) Subjects who ingest excessively soy products such as natto and soy drinks (5) Subjects who take foods rich in lactic acid bacteria (yogurt, lactic acid bacteria beverages, etc.) at least three times a week (6) Subjects who have had ovarian, uterine or orchiectomy surgery (7) Excessive smokers, alcohol addicts, and subjects with extremely irregular diets (8) Subjects whose overall score of the Pittsburgh Sleep Questionnaire at the pre-examination is less than 3, or more than 10, or who are estimated to have sleep disorders such as insomnia from the answers (9) Subjects whose BMI are 30.0 kg/m^2 or more (10) Subjects who are awakened midway through external factors such as child crying at least twice a week (11) Night and day shift worker or manual laborer (12) Subjects who have under treatment or a history of serious disease (e.g., diabetes, liver disease, kidney disease, or heart disease) and disease to affect the adrenal cortical hormone secretion (13) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (14) Subjects considered unsuitable as subjects based on pre-examination laboratory test values, measurement values, and prostate tumor markers (15) Subjects who have participated in other clinical study within the last one month or have plan to participate other clinical studies (16) Subjects who are pregnant or lactating, or plan to become pregnant or lactate during the study (17) Subjects who are judged as unsuitable for the study by investigator for other reasons
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Soichi Middle name Last name Tanabe
Organization	NISSIN FOODS HOLDINGS CO., LTD. R&D Platform NISSIN Global Innovation Center
Division name	Health Science Research Office
Zip code	192-0001
Address	2100, Tobukimachi, Hachioji, Tokyo
TEL	042-696-7685
Email	soichi.tanabe@nissin.com

Public contact
Name of contact person	1st name Shinsuke Middle name Last name Tsuji
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Zip code	150-0021
Address	Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	s.tsuji@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd
Institute
Department

Funding Source
Organization	NISSIN FOODS HOLDINGS 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	Medical Station Clinic Research Ethics Committee
Address	3-12-8, Takaban, Meguroku, Tokyo
Tel	03-6452-2712
Email	t.saito@ttc-smo.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	2021 Year 12 Month 17 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	Completed
Date of protocol fixation	2020 Year 08 Month 06 Day
Date of IRB	2020 Year 08 Month 06 Day
Anticipated trial start date	2020 Year 08 Month 07 Day
Last follow-up date	2020 Year 12 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 08 Month 20 Day
Last modified on	2021 Year 04 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047344