UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055405 |
|---|---|
| Receipt number | R000063272 |
| Scientific Title | Daily stress reduction through synbiotic food |
| Date of disclosure of the study information | 2024/09/05 |
| Last modified on | 2025/09/04 09:58:29 |
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Basic information
Public title
Daily stress reduction through synbiotic food
Acronym
Daily stress reduction through synbiotic food
Scientific Title
Daily stress reduction through synbiotic food
Scientific Title:Acronym
Daily stress reduction through synbiotic food
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
On-site training causes a greater deal of tension and anxiety for students than the passive lecture in campus and induces stress reaction. The stress response is complex, and it affects the autonomic nervous system, the gastro-intestinal system, the neuroendocrine system, and the immune system, leading to the development of constipation and/or diarrhea and worsening skin conditions, then the intestinal tract, rephrasing as the "second brain", is strongly affected by stress. We hypothesized that a favorable change in the intestinal environment would lead to stress reduction and improve bowel movements and skin conditions. This study will analyze the changes in intestinal flora, stool organic acid concentration, microbial metabolite concentration, and skin condition and stress reaction before and after the intake of synbiotic foods during on-site training.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
salivary cortisol and alpha-amylase (before, after 2 weeks and 4 weeks intake)
Key secondary outcomes
intestinal flora, stool organic acid concentration, microbial metabolite concentration, skin condition, stress status
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Intervention group takes 2 packets of G fine, a synbiotics, per day for 4 weeks (with 100 ml water per packet)
Interventions/Control_2
Control group takes 100 ml of water twice a day
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
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The following conditions must be met during the study period: (1) Constipation tendency with 3-5 bowel movements per week, (2) No diet supplements, replacement diets, or beauty treatments, (3) No facial beauty treatments, and (4) No excessive UV exposure such as swimming, mountain climbing, skiing, or sunbathing during the study period.
Key exclusion criteria
1) Those who are taking drugs such as antibiotics that affect digestion and absorption, 2) Those who have digestive disorders (including irritable bowel syndrome) or a history of surgery (excluding appendectomy) that affect digestion and absorption or defecation, 3) Those who have skin-related diseases, 4) Those who suffer from heart or kidney disease, diabetes or other serious diseases, 5) Those who are participating in other research or surveys, 6) Those who have a disordered diet such as extreme fasting or overeating, and 7) Those who have a history of certain health problems that may be related to bowel regulation. (5) Those who are participating in other research or investigation, (6) Those who are exposed to a large amount of ultraviolet rays on a daily basis, (7) Those who have a disordered diet such as extreme fasting or overeating, (8) Those who cannot stop additional intake of food for specified health use, functional foods, yogurt, lactic acid bacteria drinks, supplements or other food/beverage with possible functionality that is believed to be involved in the bowel regulating action, except for those who are unable to stop the intake of such foods or beverages. (viii) Those who are unable to stop the intake of foods/drinks that are considered to be involved in intestinal regulation, except for natto, which shall be prohibited during the study period, (ix) Those who have allergies (to foods related to the test foods), (x) Those who are pregnant, lactating, or intend to become pregnant during the study period. (11) Any other person whom the principal investigator deems inappropriate as a subject for this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Miyoshi |
Organization
Kobe University Graduate School of Health Sciences
Division name
Department of Biophysics
Zip code
6540142
Address
7-10-2, Tomogaoka, Suma-ku, Kobe
TEL
0787964615
miyoshi@harbor.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Miyoshi |
Organization
Kobe University Graduate School of Health Sciences
Division name
Department of Biophysics
Zip code
6540142
Address
7-10-2, Tomogaoka, Suma-ku, Kobe
TEL
0787964615
Homepage URL
miyoshi@harbor.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Kobe University Graduate School of Health Sciences
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Graduate School of Health Sciences
Address
7-10-2, Tomogaoka, Suma-ku, Kobe
Tel
0787964615
miyoshi@harbor.kobe-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
| 2024 | Year | 09 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2027 | 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
| 2024 | Year | 09 | Month | 03 | Day |
Last modified on
| 2025 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063272
