UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055687 |
|---|---|
| Receipt number | R000063621 |
| Scientific Title | Effect of Daily Intake of lactic acid bacteria on Mood States: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2024/12/06 09:46:25 |
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Basic information
Public title
Effect of Daily Intake of lactic acid bacteria on Mood States: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study
Acronym
Effect of Daily Intake of lactic acid bacteria on Mood States
Scientific Title
Effect of Daily Intake of lactic acid bacteria on Mood States: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study
Scientific Title:Acronym
Effect of Daily Intake of lactic acid bacteria on Mood States
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of continuous intake of the test food containing lactic acid bacteria for 12 weeks on mood state, using a placebo as a control
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
POMS-2 Adult Short Version
Key secondary outcomes
1) SMI
2) OSA sleep inventory MA version
3) Visual Analog Scale - Fatigue
4) Female hormones in the blood (E2, FSH, LH, P4)
5) Stress-related markers in the blood
6) Salivary cortisol
7) Stool frequency, stool shape, stool volume, feeling of incomplete defecation
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of tablets containing lactic acid bacteria for 12 weeks
Interventions/Control_2
Intake of placebo tablets 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
| 69 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Healthy women aged 45 to 69 years old at the time of consent for the clinical trial
2.Subjects who experience stress in their daily lives
3.Subjects with relatively high TMD score (T score) of the POMS-2 short form for adults
4.Subjects who have been informed about the purpose and details of the study, possess the capacity to consent, understand the information thoroughly, and can provide informed consent electronically
Key exclusion criteria
1.Subjects currently receiving medical treatment for gynecological, thyroid, autonomic nervous system, or mental disorders, or those planning to during the study
2.Subjects currently taking medication that affects menopausal symptoms
3.Subjects who have undergone oophorectomy or hysterectomy
4.Subjects who have previously received hormone replacement therapy
5.Subjects currently receiving medical treatment for chronic diseases
6.Subjects being treated for malignant tumors, or cerebrovascular, heart, liver, kidney, blood, or endocrine disorders, or those with a serious medical history in these areas
7.Subjects receiving treatment for digestive diseases, or those with a significant medical history in these areas (excluding appendectomy)
8.Subjects with significant abnormalities in vital signs, blood, or physical tests
9.Subjects suspected of having HBV, HCV, syphilis, or HIV
10.Subjects who have felt unwell or experienced a decline in physical condition due to blood sampling
11.Subjects who have recently donated blood or cannot refrain during the study
12.Women who are breastfeeding, pregnant, possibly pregnant, or planning to become pregnant during the study
13.Subjects suspected of having a mental disorder based on the SDS score at web screening and medical interview
14.Subjects with SMI score of >= 51 at the web screening
15.Subjects who regularly consume functional foods and cannot stop during the study
16.Subjects who regularly consume foods containing the same component as the test food
17.Subjects who may have blood contamination in their saliva sample
18.Subjects with allergies to the test food
19-21.Heavy smokers, regular alcohol consumers, extremely irregular eating habits
22.Subjects expecting significant changes in their living environment, diet, and exercise habits during the study
23.Subjects in other trials within 4 weeks or planning to join others during the study
24.Subjects deemed ineligible by the principal medical investigator
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Soma |
| Middle name | |
| Last name | Ode |
Organization
Macromill, Inc.
Division name
Life Science Division, Clinical Research Unit
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo Japan
TEL
03-6716-0700
ohde@macromill.com
Public contact
Name of contact person
| 1st name | Aya |
| Middle name | |
| Last name | Takahashi |
Organization
Macromill, Inc.
Division name
Life Science Division, Clinical Research Unit
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo Japan
TEL
03-6716-0700
Homepage URL
ay_takahashi@macromill.com
Sponsor or person
Institute
Macromill, Inc.
Institute
Department
Personal name
Funding Source
Organization
House Wellness Foods 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
Ethical Committee of Kobuna Orthopedics Clinic
Address
311-2 Gokan-machi, Maebashi-shi, Gumma Japan, 371-0813
Tel
027-212-5608
sagawa@mc-connect.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
医療法人財団同仁記念会 明和病院（東京）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 01 | Day |
Last modified on
| 2024 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063621
