UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059139 |
|---|---|
| Receipt number | R000067647 |
| Scientific Title | Lifestyle Intervention Study for Healthy Blood Pressure Through Gut Environment Modulation |
| Date of disclosure of the study information | 2025/09/19 |
| Last modified on | 2025/09/19 14:22:49 |
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Basic information
Public title
Lifestyle Intervention Study for Healthy Blood Pressure Through Gut Environment Modulation
Acronym
Lifestyle Intervention Study for Healthy Blood Pressure Through Gut Environment Modulation
Scientific Title
Lifestyle Intervention Study for Healthy Blood Pressure Through Gut Environment Modulation
Scientific Title:Acronym
Lifestyle Intervention Study for Healthy Blood Pressure Through Gut Environment Modulation
Region
| Japan |
Condition
Condition
Healthy male
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of dietary ingredient intake in improving hypertension through modulation of the gut environment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure (Systolic/diastolic blood pressure)
Key secondary outcomes
- Gut microbiota
- Gut metabolomes
- Defecation status (frequency, quantity, property, color, feeling of incomplete evacuation, abdominal pain, odor)
- Abdominal symptoms (bloating, belching, gas) at times other than during defecation
- Physiological measurements
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of the test food (1 carton per day)
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male
Key inclusion criteria
(1) Male subjects aged 40 over but under 8 at the time conset was obtained.
(2) Subjects with "high normal" or "high" blood pressure readings taken in a clinic/home blood pressure.
(3) Subjects who do not attending regular hospital visits for the purpose of treatment related to high blood pressure.
(4) Subjects who can show their understanding of the study procedure and agreement with participating in the study by informed consent prior to the study.
Key exclusion criteria
(1) Subjects who are unable to discontinue consumption of products equivalent to "vinegar drink" from consent acquisition to the conclusion of the trial (use of vinegar as a condiment is permissible).
(2) Subjects who are participating in a clinical study of another drug or health food, or within 4 weeks of the completion of the study, or who is scheduled to participate in another clinical study after consent to participate in this study.
(3) Subjects with extremely irregular lifestyles (late-night work, shift work, etc.).
(4) Subjects with extremely irregular eating habits.
(5) Heavy alcohol drinkers.
(6) Subjects whose roommates plan to participate in the study.
(7) Subjects who are expected to undergo a major change in their family, work, or other living environment (e.g., relocation, transfer, etc.) during the study.
(8) Subjects who have taken drugs (antibiotics, antiflatulent, laxatives, etc.) that would affect the study, one month prior to the preliminary test, or during the study.
(9) Subjects undergoing medication treatment for ongoing care.
(10) Subjects who have undergone surgery that may affect the study (colonoscopy, removal of gallstones or gallbladder, gastric bypass surgery, etc.) within 6 months prior to obtaining consent.
(11) Subjects with a history of appendectomy.
(12) Subjects currently receiving treatment with antihypertensive agents, or those who have previously received the treatment
(13) Subjects with a history of serious diseases of the heart, liver, kidneys, digestive organs, etc.
(14) Subjects allergic to medicines and foods.
(15) Subjects who are judged by the principal investigator or sub-investigator to be inappropriate to participate in this study.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Tatsuhiro |
| Middle name | |
| Last name | Nomaguchi |
Organization
Metagen, Inc.
Division name
Product Development Support Division
Zip code
108-0023
Address
Campus Innovation Center INDEST 404, 3-3-6 Shibaura, Minato-ku, Tokyo, Japan
TEL
+81-235-64-0330
research@metagen.co.jp
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Fukuda |
Organization
Kanagawa Institute of Industrial Science and Technology
Division name
Gut environment design group
Zip code
210-0821
Address
LiSE4C-6, 3-25-13 Tonomachi, Kawasaki-ku, Kawasaki City, Kanagawa, Japan
TEL
+81-44-819-2031
Homepage URL
rep-kenkyu@kistec.jp
Sponsor or person
Institute
Metagen, Inc.
Institute
Department
Personal name
Funding Source
Organization
Kanagawa prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
- Kanagawa Institute of Industrial Science and Technology
- Kanagawa Cancer Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongokucho, Chuo-ku, Tokyo 103-0021, Japan
Tel
+81-3-6225-9005
IRB@cpcc.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 19 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 19 | Day |
Last modified on
| 2025 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067647
