Healthy male
Conditions
Interventions
Consumption of the test food (1 carton per day)
Sponsors
Metagen, Inc.
- Kanagawa Institute of Industrial Science and Technology - Kanagawa Cancer Center
Eligibility
Sex/Gender
Male
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood pressure (Systolic/diastolic blood pressure) | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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 | — |
Countries
Japan
Contacts
Public ContactShinji Fukuda
Kanagawa Institute of Industrial Science and Technology Gut environment design group
Outcome results
None listed