UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051307 |
|---|---|
| Receipt number | R000058524 |
| Scientific Title | Study to confirm the anti-stress effect of continuous ingestion of foods containing Lactobacillus brevis subsp. coagulans (Labre). |
| Date of disclosure of the study information | 2023/06/09 |
| Last modified on | 2023/06/09 16:10:18 |
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Basic information
Public title
Study to confirm the anti-stress effect of continuous ingestion of foods containing Lactobacillus brevis subsp. coagulans (Labre).
Acronym
Study to confirm the anti-stress effect of continuous ingestion of foods containing Lactobacillus brevis subsp. coagulans (Labre).
Scientific Title
Study to confirm the anti-stress effect of continuous ingestion of foods containing Lactobacillus brevis subsp. coagulans (Labre).
Scientific Title:Acronym
Study to confirm the anti-stress effect of continuous ingestion of foods containing Lactobacillus brevis subsp. coagulans (Labre).
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the anti-stress effect and safety of continuous intake of foods containing Labre.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in salivary chromogranin A, Total Mood Disturbance (TMD: overall mood disorder degree) as measured by the Japanese short version of the Profile of Mood States 2nd Edition (POMS 2)
Key secondary outcomes
Change in salivary Cortisol and s-IgA, Visual Analogue Scale of stress and tiredness, Change in PSQI
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
Test food: Food containing Labre
Interventions/Control_2
Placebo food: Food free of Labre
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Japanese men and women aged between 20 and 64 at the time of obtaining consent to participate in the study
(2) Subjects with BMI between 18.5 and 30.0 at the screening test
(3) Subjects who experience stress in daily life
(4) Subjects who can be available at the research site on the designated dates
(5) Subjects who have received sufficient explanations about the purpose and content of this study, have the ability to consent, volunteer to participate in this study in writing with a good understanding.
Key exclusion criteria
(1) Subjects who have a history of heart, liver, kidney disease, organ damage, diabetes, or other serious diseases
(2) Subjects who have a history of gastrointestinal surgery (excluding appendectomy)
(3) Subjects who are currently receiving medical drug treatment
(4) Subjects who are pregnant, wish to become pregnant during the study, or are breastfeeding
(5) Subjects with intention to improve fatigue, stress or sleep who receive any treatments (including hospital visits or medical treatment) or who use any pharmaceuticals or health foods.
(6) Subjects who have been diagnosed with chronic fatigue syndrome
(7) Subjects who are under psychiatric consultation or have history of psychiatric consultation for mental disorders (depression, etc.) or sleep disorders
(8) Subject who take beverage containing large amount of caffeine (400 mg/day or more) in daily base
(9) Subjects who take foods or supplements containing lactobacilli or bifidobacteria 3 times or more a week (Suguki pickle, bran pickle, kimchi, "Labre capsules", etc.)
(10) Shift workers including late-night shifts, or subjects who have extremely irregular eating, sleeping, or other lifestyle habits
(11) Subjects who drink more than 60 g pure alcohol equivalent/day on average
(12) Smokers
(13) Subjects who are expected to undergo a major change in family or work environment or other stressful situation (e.g., job change, moving, marriage) from one month prior to the screening test to the end of this study.
(14) Subjects who exercise heavily in daily base
(15) Subjects who donated blood within 3 months at screening
(16) Subjects who are participating in clinical research or monitoring (food, pharmaceuticals, cosmetics) other than this research, or plan to participate during this research period
(17) Subjects who are judged to be inappropriate for this study with other reasons by the principal investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Takano |
Organization
Medical Corporation Hokubukai Utsukushigaoka Hospital
Division name
Clinical Pharmacology Center
Zip code
004-0839
Address
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido 004-0839 Japan
TEL
011-882-0111
takano@ughp-cpc.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Matsuda |
Organization
Medical Corporation Hokubukai Utsukushigaoka Hospital
Division name
Clinical Pharmacology Center
Zip code
004-0839
Address
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido 004-0839 Japan
TEL
011-882-0111
Homepage URL
matsuda@ughp-cpc.jp
Sponsor or person
Institute
Medical Corporation Hokubukai Utsukushigaoka Hospital
Institute
Department
Personal name
Funding Source
Organization
Shinwayakuhin 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 Corporation Hokubukai Utsukushigaoka Hospital Ethics Review Committee
Address
61-1, Shinei, Kiyota-ku, Sapporo, Hokkaido 004-0839 Japan
Tel
011-882-0111
matsuda@ughp-cpc.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
| 2023 | Year | 06 | Month | 09 | 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
50
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
| 2023 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 09 | Day |
Last modified on
| 2023 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058524
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
