High-normal blood pressure and Grade 1 hypertension patients
Conditions
Interventions
Single ingestion of study food substance (including involved raw materials 45g).
Single ingestion of study food substance (including involved raw materials 90g).
Single ingestion of control food subst
Sponsors
CROee.INC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects with high normal blood pressure (systolic BP from 130 to 139, or diastolic BP from 85 to 89 mm Hg) and grade 1 hypertension (systolic BP from 140 to 159, or diastolic BP from 90 to 99 mm Hg) 2) BMI more than 18.5 kg/m2 but less than 30 kg/m2 2) Subjects who give consent in writing
Exclusion criteria
Exclusion criteria: 1) Subjects who have serious disorders on hepatic, kidney, cardiac, lung, digestive organs, blood, endocrine system, metabolic system, (2) Subjects who are under medication on a steady basis or history of medication for serious disorders (3) Subjects who are under treatment at healthcare facility for digestive system that effects on this study or have history of operation on digestive system (except appendectomy) 4) Subjects who have history of intolerance to study food substance 5) Subject with allergy to fruit 6) Subjects who are in pregnancy, lactation, or who are willing to become pregnant 7) Subjects who participated in other drug or food study within 1 month 8) Heavy smoker (20 or more/day) and heavy drinker (converted to alcohol 30g or more/day), or subjects with irregular lifestyle (9) Subjects who are ineligible due to physician's judgment based on background of subject, physical finding, interview
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Systolic blood pressure and diastolic blood pressure | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjective evaluation questionnaire | — |
Countries
Japan
Contacts
Public ContactShigeru Imai
CROee.INC Evidence Division
Outcome results
None listed