N/A(healthy adults with normal high blood pressure or Grade 1 hypertension
Conditions
Interventions
Oral ingestion of the test products containing fermented soba extract (100g per a day
12 weeks)
Oral ingestion of the placebo not containing fermented soba extract (100g per a day
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Japanese males and females aged 30-70 years [2]Individuals who are healthy and are not received treatment of disease [3]Individuals who is high normal blood pressure (SBP: 130-140mmHg and/or DBP: 85-90mmHg) and Grade 1 hypertension (SBP: 140-160mmHg and/or DBP: 90-100mmHg) [4]Individuals whose written informed consent has been obtained [5]Individuals judged appropriate for the study by the principal
Exclusion criteria
Exclusion criteria: [1]Individuals using medical products [2]Individuals whose condition is secondary hypertension (ex. renal artery stenosis, renal hypertension, renovascular hypertension, pheochromocytoma, disease of adrenal cortex) [3]Individuals who have a history of bronchial disease (ex. asthma, tuberculosis, pleurisy) [4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease [5]Individuals who are sensitive to a food containing soba and test product or other foods, and medical products [6]Individuals who have a history of hepatitis [7]Individuals with serious anemia [8]Individuals whose BMI is over 30 [9]Individuals who have a habit of smoking [10]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day) [11]Individuals whose life style will change during the test period (ex. a night shift, travel for a long time, job transfer) [12]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplyments in the past 3 month or will ingest those foods during the test period [13]Individuals who participated in other clinical studies in the past three months [14]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months [15]Individuals who are or are posslibly, or are lactating [16]Individuals judged inappropriate for the study by the principal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Blood pressure, pulsation (Screening, Week 0, Week 4, Week 8, Week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| [1]Adrenal medulla test (Week 0, Week 12) [2]Hematologic test [3]Blood biochemical test [4]Urine analysis [5]Hight(Screening) [6]Weight, body fat percentage, BMI (Screening, Week 0, Week 4, Week 8, Week 12) [7]Doctor's questions (Screening, Week 0, Week 4, Week 8, Week 12) [8]Subject's diary(From the first day of ingestion of a test material to the last day of the test) | — |
Countries
Japan
Contacts
Public ContactToshiyasu Tamura
TES Holdings Co., Ltd. Department of Clinical Trial
Outcome results
None listed