UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041472 |
|---|---|
| Receipt number | R000047344 |
| Scientific Title | Effects of lactic acid bacteria intake on perimenopausal men and women on menopause-like symptoms, sleep and biomarkers |
| Date of disclosure of the study information | 2021/12/17 |
| Last modified on | 2021/04/12 18:47:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
s.tsuji@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047344
