UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053382 |
|---|---|
| Receipt number | R000060928 |
| Scientific Title | Relationship among emotion regulation, gut microbiota, and inflammation |
| Date of disclosure of the study information | 2024/01/18 |
| Last modified on | 2025/04/11 14:59:52 |
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Basic information
Public title
Relationship among emotion regulation, gut microbiota, and inflammation
Acronym
Relationship among emotion regulation, gut microbiota, and inflammation
Scientific Title
Relationship among emotion regulation, gut microbiota, and inflammation
Scientific Title:Acronym
Relationship among emotion regulation, gut microbiota, and inflammation
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship among emotion regulation, gut bacteria, and inflammation in the body of healthy participants.
Basic objectives2
Others
Basic objectives -Others
Exploratory research
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire test (Japanese version of the Stress Mindset Measure, Coping Inventory for Stressful Situations-Japanese version, Japanese version of Somatosensory Amplification Scale, Emotion Regulation Questionnaire-Japanese version, Japanese version of the Perth Emotion Regulation Competency Inventory, Multidimensional Assessment of Interoceptive Awareness, The Cumulative Fatigue Symptoms Index, POMS 2-A short, State-TraitAnxietyInventory, Diagnostic of functional constipation, Diarrhea and loose stool questionnaire, Japanese version BDI-II, Japanese version of the Perceived Stress Scale, Stress Response Scale-18, Pittsburgh Sleep Quality Index-Japanese version, Visual Analog Scale)
Fecal examination
Blood test (inflammatory markers; IL-6, TNF-alpha, high-sensitivity CRP, IL-1beta)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Japanese males and females who are aged 30 years or older and younger than 60 years at the time of written informed consent.
2.Subjects who completed high school or higher education.
3.Subjects whose BMI is 18.5 kg/m2 or more and less than 30 kg/m2.
4.People who are fully explained the purpose and details of the study, have ability to consent, are volunteering to participate in the study with a full understanding of the explanation, and have consented to participate in the study in writing.
Key exclusion criteria
1.Subjects with symptoms of dementia or those previously diagnosed with dementia.
2.Subjects previously diagnosed with alcohol-related diseases or those being treated for such diseases.
3.Subjects with depressive symptoms or those previously diagnosed with depression.
4.Subjects who have previously had dysregulation of the hypothalamic-pituitary-adrenal axis.
5.Subjects on hormonal therapy or those previously diagnosed with menopausal by a physician.
6.Subjects with a history of gastrointestinal surgery (e.g., gastric resection).
7.Subjects with periodontitis or those being treated for periodontitis.
8.Subjects who are currently pregnant or breastfeeding, or may become pregnant or start breastfeeding during the study period.
9.Subjects who work night shifts or have an irregular life by working in night and day shifts during the study or those engaged in manual labor such as carrying heavy goods.
10.Vegetarian.
11.Smoking subjects or those who have stopped smoking within 12 months before the date of informed consent.
12.Subjects on brain function-related treatment or those prescribed associated medicine.
13.Subjects with sleep-related disorders such as sleep apnea syndrome, restless legs syndrome, or insomnia or those aware of having such disorders.
14.Subjects who have been taking any medicine or health food, including "food for specified health uses," "food with nutrient function claims," or "food with functional claims," containing any ingredients that may affect the study results once weekly or more often on a continuous basis (however, those able to stop taking the medicine/food upon providing informed consent and throughout the study are allowed to be included).
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Hidemasa |
| Middle name | |
| Last name | Toya |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0014
Address
Round Cross Tamachi 9F, 5-31-19 Shiba, Minato-ku, Tokyo 108-0014 Japan
TEL
03-3431-1260
toya@huma-rd.co.jp
Public contact
Name of contact person
| 1st name | Hidemasa |
| Middle name | |
| Last name | Toya |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0014
Address
Round Cross Tamachi 9F, 5-31-19 Shiba, Minato-ku, Tokyo 108-0014 Japan
TEL
03-3431-1260
Homepage URL
toya@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
FANCL 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
Medical Corporation Taifukukai, Osaka Nishiumeda Clinic
Address
Maruito Nishi-Umeda Building 3F, 3-3-45 Umeda Kita-ku, Osaka-shi, Osaka 530-0001 Japan
Tel
06-4797-5660
n-irb@ml.taifukukai.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 | 01 | Month | 18 | 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
178
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
| 2023 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 09 | Day |
Date of closure to data entry
| 2024 | Year | 04 | Month | 15 | Day |
Date trial data considered complete
| 2024 | Year | 05 | Month | 08 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Exploratory research
(Exclusion criteria continued)
15.Subjects who are unable to interrupt the intake of prebiotic or probiotic foods, medicine containing ingredients that may affect the test results, health foods, foods for specified health uses, foods with nutrient function claims, or foods with functional claims for 6 days including the day of the test from 5 days prior to the day of the test for this study.
16.Subjects currently on treatment for symptoms of diarrhea or constipation.
17.Subjects who have taken antibiotics within 2 months before the date of informed consent.
18.Subjects who donated more than 200 mL or 400 mL of whole blood, plasma, or platelets within 3 months before the date of informed consent.
19.Subjects who participated in another clinical study/research within 1 month before the date of informed consent or who plan to participate in another clinical study/research during the study period.
20.Subjects with current or past history of serious medical conditions requiring constant medication such as cranial nerve disorders, malignant tumors, immunological diseases, diabetes, liver disease (hepatitis), renal, cardiac, thyroid diseases, adrenal diseases, or metabolic diseases.
21.Subjects who have difficulty complying with recording of each survey form.
22.Subjects deemed unsuitable for the study by the test director or principal investigator on the basis of laboratory, anthropometric, and physical examination results.
23.Subjects deemed otherwise unsuitable for the study by the test director or principal investigator.
Management information
Registered date
| 2024 | Year | 01 | Month | 18 | Day |
Last modified on
| 2025 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060928
