UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027303 |
|---|---|
| Receipt number | R000031285 |
| Scientific Title | Research on a lactic acid bacterium preparation for stress relief |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2019/11/11 10:51:48 |
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Basic information
Public title
Research on a lactic acid bacterium preparation for stress relief
Acronym
Research on a lactic acid bacterium preparation for stress relief
Scientific Title
Research on a lactic acid bacterium preparation for stress relief
Scientific Title:Acronym
Research on a lactic acid bacterium preparation for stress relief
Region
| Japan |
Condition
Condition
Healthy adults who feel stress
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the effects of LAB-ingestion on mental and physical conditions under chronic stress
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate the effects of LAB-ingestion on mental and physical conditions at 12 and 24 weeks after the start of intervention by stress-related questionnaires and several measurement items
Key secondary outcomes
Evaluate the effects of LAB-ingestion on sleep quality and abdominal symptoms by questionnaires and related-measurement items
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
Daily intake of formulation including LAB for 24 weeks before the National Examination for Medical Practitioners
Interventions/Control_2
Daily intake of placebo formulation without LAB for 24 weeks before the National Examination for Medical Practitioners
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects are without major problems in psychological and physical health.
Key exclusion criteria
1. Subjects having history of psychiatric or somatic diseases in the past and present.
2. Subjects taking medication at least for three months prior to the enrollment and during the experimental period.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kazuhito |
| Middle name | |
| Last name | Rokutan |
Organization
Tokushima University
Division name
Dept. of Pathophysiology, Inst. of Biomedical Sciences
Zip code
7708503
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-9004
rokutan@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kensei |
| Middle name | |
| Last name | Nishida |
Organization
Tokushima University
Division name
Dept. of Pathophysiology, Inst. of Biomedical Sciences
Zip code
7708503
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-9004
Homepage URL
knishida@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Asahi Group Holdings, 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
Clinical Trial Center For Development Therapeutics
Address
2-50-1 Kuramotocho, Tokushima city
Tel
+81-88-633-9294
awachiken@tokushima-u.ac.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
| 2017 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Nutrients 2019, 11(8), 1859; https://doi.org/10.3390/nu11081859
Publication of results
Published
Result
URL related to results and publications
Nutrients 2019, 11(8), 1859; https://doi.org/10.3390/nu11081859
Number of participants that the trial has enrolled
74
Results
1. CP2305 reduced anxiety and sleep disturbance relative to placebo.
2. CP2305 shortened sleep latency and wake time after sleep onset and increased the delta power ratio in the first sleep cycle.
3. CP2305 lowered salivary chromogranin A levels compared with placebo. 4. CP2305 administration attenuated the stress-induced decline of Bifidobacterium spp. and the stress-induced elevation of Streptococcus spp.
Results date posted
| 2019 | Year | 11 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
healthy young adults (average age 24.9 +- 0.5)
Participant flow
The study was designed as a double-blind, placebo-controlled, parallel-group clinical trial and ran from July 2017 to March 2018.
Seventy-four sixth-grade medical students were recruited at Tokushima University, Tokushima, Japan. Written informed consent was obtained from all participants, and they were randomly allocated to either the CP2305 or placebo group with a stratified randomization by gender.
Fourteen of the 74 participants were excluded as they were taking medications, or for hormonal contraceptives and active disease (mental disease, inflammatory disease, bone disease, and hormonal disorder).
Finally, 29 participants (20 males and nine females) were allocated to the CP2305 group and 31 (21 males and 10 females) to the placebo group.
The participants were instructed to ingest two tablets (placebo or CP2305) once daily for 24 weeks.
Adverse events
No adverse event was reported.
Outcome measures
1. Questionnaires to Assess Mental and Physical States.
2. Measurements of Salivary Cortisol and Chromogranin A (CGA).
3. Measurement and Assessment of Single-Channel Sleep Electroencephalogram (EEG).
4. Assessment of Stool Properties and Bowel Habits.
5. Measurement of Short-Chain Fatty Acid (SCFA) Concentrations in Feces.
6. Fecal Microbiota Analysis.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 10 | Day |
Last modified on
| 2019 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031285
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| Registered date | File name |
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