UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038045 |
|---|---|
| Receipt number | R000043367 |
| Scientific Title | Effects of lactic acid bacteria intake on perimenopausal women on menopause-like symptoms, sleep and biomarkers |
| Date of disclosure of the study information | 2020/12/19 |
| Last modified on | 2019/12/26 19:45:17 |
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Basic information
Public title
Effects of lactic acid bacteria intake on perimenopausal women on menopause-like symptoms, sleep and biomarkers
Acronym
Effects of lactic acid bacteria intake on perimenopausal women on menopause-like symptoms, sleep and biomarkers
Scientific Title
Effects of lactic acid bacteria intake on perimenopausal women on menopause-like symptoms, sleep and biomarkers
Scientific Title:Acronym
Effects of lactic acid bacteria intake on perimenopausal women on menopause-like symptoms, sleep and biomarkers
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the effects of lactic acid bacteria on menopause-like symptoms, sleep and biomarkers after 8 weeks of ingestion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Kupperman Kohnenki Shogai Index (KKSI) at 8 weeks ingestion
Key secondary outcomes
1. Swelling
2. Blood flow
3. Stiff shoulder VAS
4. QOL questionnaire (SF-36)
5. Pittsburgh Sleep Quality Index (PSQI-j)
6. OSA sleep inventory MA version
7. Heart rate / activity survey
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of test food anytime except before going to bed. Or ingestion of test food before going to bed.
Interventions/Control_2
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
| 55 | years-old | > |
Gender
Female
Key inclusion criteria
(1) Female older than 45 years and younger than 55 years
(2) Subjects who are aware of aging irregular menstruation, indefinite complaints and poor sleep
(3) Subjects who can appropriately conduct heart rate and activity surveys
(4) Subjects judged to be healthy by a doctor
Key exclusion criteria
(1) Subjects who can not properly collect hair, saliva and blood flow test
(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 have passed more than one year after menopause
(5) Subjects who take excessive amounts of soybean products such as natto and soy beverages
(6) Subjects who take foods rich in lactic acid bacteria (yogurt, lactic acid bacteria beverages, etc.) at least three times a week
(7) Subjects who have undergone oophorectomy or hysterectomy
(8) Excessive smokers, alcohol addicts, and subjects with extremely irregular diets
(9) 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
(10) Subjects whose BMI are 30.0 kg/m^2 or more
(11) Subjects who are awakened midway through external factors such as child crying at least twice a week
(12) Night and day shift worker or manual laborer
(13) 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
(14) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(15) Subjects who are judged as unsuitable for the study because of clinical test, anthropometric test and physical examination in pre-inspection
(16) Subjects who have participated in other clinical study within the last one month or have plan to participate other clinical studies
(17) Subjects who are pregnant or lactating, or plan to become pregnant or lactate during the study
(18) Subjects who are judged as unsuitable for the study by investigator for other reasons
Target sample size
10
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
Aisei Hospital Ueno Clinic Research Ethics Committee
Address
2-18-6, Higashiueno, Taitou-ku, Tokyo
Tel
03-6455-0880
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
| 2020 | Year | 12 | 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
Completed
Date of protocol fixation
| 2019 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 18 | Day |
Last modified on
| 2019 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043367
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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