UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045547 |
|---|---|
| Receipt number | R000052003 |
| Scientific Title | A randomized, placebo-controlled, double blind, parallel study of the effect of lactic acid bacteria on the imbalance and discomfort of mental and physical conditions in healthy peri/post-menopause females |
| Date of disclosure of the study information | 2022/02/16 |
| Last modified on | 2022/05/24 13:27:43 |
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Basic information
Public title
Examination study of the effect of lactic acid bacteria on the imbalance and discomfort of mental and physical conditions in healthy peri/post-menopause females
Acronym
Examination study of the effect of lactic acid bacteria on the imbalance and discomfort of mental and physical conditions in healthy peri/post-menopause females
Scientific Title
A randomized, placebo-controlled, double blind, parallel study of the effect of lactic acid bacteria on the imbalance and discomfort of mental and physical conditions in healthy peri/post-menopause females
Scientific Title:Acronym
A randomized, placebo-controlled, double blind, parallel study of the effect of lactic acid bacteria on the imbalance and discomfort of mental and physical conditions in healthy peri/post-menopause females
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to investigate the effects of continuation intake of test food for 12 weeks on the imbalance and discomfort of mental and physical condition in healthy Japanese peri/post-menopause females who aged order 45 years or less than 55 years.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Kupperman's menopausal index
Key secondary outcomes
Izumo scale
SF-8 Japanese version
Questionnaire for skin condition
FSH
Estrone
Estradiol
Defecation frequency
Volume of stool
Property of stool
Enzymatic activity of stool
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
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take 1 capsule of the test food for 12 weeks.
Interventions/Control_2
Take 1 capsule of the placebo food for 12 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
| 54 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Japanese female aged older 45 years or and less than 55 years at the time of the informed consent
2) Subjects who feels their menstrual cycle, amount of menstrual blood, menstrual period, and degree of abdominal pain before and during menstruation have changed compared to those in their 20s (including menopause)
3) Subjects who feel menopausal symptoms (hot flashes, sweating) within the range that does not interfere with daily life
4) Subjects who are not suffering from serious diseases
5) Subjects who can enter examinations and records by visiting the hospital on a specified date
6) Subjects who have understood the purpose of the study and agreed to participate it by signing the written informed consent
Key exclusion criteria
1) Subjects who are suffering from or treated for diseases that affect menopausal symptoms, including thyroid and psychological disorders
2) Subjects who are suffering from menopausal symptoms due to surgical procedures such as oophorectomy
3) Subjects who are judged by the principal investigator to require treatment such as medication for menopausal symptoms
4) Subjects who had a history of menopausal disorders
5) Subjects who regularly use pharmaceuticals, Food for Specified Health Uses, Foods with Functional Claims, health food, and supplements that affect this study
6) Subjects who have an allergy for the pharmaceuticals and foods that affect this study
7) Subjects who have hypersensitivity reactions for test foods
8) Subjects who drink more than 20 grams of alcohol per day
9) Subjects who smoke more than 20 cigarettes per day
10) Subjects who are unable to refrain from consuming Food for Specified Health Uses, Foods with Functional Claims, and other so-called health foods during the study
11) Subjects who have been participated in other clinical trial or trials, or wish to participate within the study period
12) Subjects who are unable to follow the doctor's instructions or are judged as an inappropriate candidate by the doctor
Target sample size
106
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Ueda |
Organization
KANEKA CORPORATION
Division name
Pharma & Supplemental Nutrition Solutions Vehicle
Zip code
1076025
Address
1-12-32, Akasaka, Minato-ku, Tokyo, Japan
TEL
03-3133-7349
Takahiro.Ueda@kaneka.co.jp
Public contact
Name of contact person
| 1st name | Soichi |
| Middle name | |
| Last name | Yoneda |
Organization
Mibyou Life Science inc
Division name
Clinical Trials Division
Zip code
1010061
Address
2-18-4 Kandamisakicho,Chiyoda-ku, Tokyo
TEL
03-6256-9600
Homepage URL
renraku@mibyou-ls.com
Sponsor or person
Institute
Mibyou Life Science inc
Institute
Department
Personal name
Funding Source
Organization
Kaneka 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
Mibyou Research Ethics Review Committee
Address
2-18-4 Kandamisakicho,Chiyoda-ku, Tokyo
Tel
03-6272-9163
renraku@npo-mibyou.com
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
医療法人社団菱秀会 金内メディカルクリニック（東京都）
医療法人社団恒新会 武蔵境クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 16 | 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
115
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
| 2021 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 22 | Day |
Last modified on
| 2022 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052003
