Subjects with high normal blood pressure and subjects with grade I hypertension
Conditions
Interventions
Intake of chocolate (4 weeks).
Intake of placebo chocolate (4 weeks).
Sponsors
CROee.INC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects who competent to consent and give voluntary consent in writing with full understanding after receiving explanation of this study aim and contents. 2) Subjects who are adults of both sexes above 40 years old- under 69 years old at the point of obtaining informed consent. 3) Subjects with high normal blood pressure or grade I hypertension at the point of screening(2) High normal blood pressure: Systolic BP from 130 to 139 mmHg and/ or diastolic blood pressure from 85 to 89 mm Hg Grade I hypertension : Systolic BP from 140 to 159 and/ or diastolic blood pressure from 90 to 99 mm Hg) 4) Subjects with BMI above 18.5 kg/ m2-under 30 kg/ m2 at the point of screening(1)
Exclusion criteria
Exclusion criteria: 1) Subjects who are under treatment for chronic disorders 2) Subjects who are in pregnancy, lactation, or who are willing to become pregnant during this study 3) Subjects who participated in other clinical trial or monitor study within 1 month prior to screening(1) 4) Subject with allergy to cacao, milk constituent and soy 5) Subjects with lactose intolerance 6) Subjects who highly intake cacao products on a daily basis 7) Subjects who intake medical chemicals, quasi-drugs, supplements, health foods, foods for specified health uses, foods with function claims that potentially influence the outcome of this study within 3 month prior to the screening(1) on regular basis or subjects who plan to intake these during this study 8) Subjects who is ineligible for this study due to principal investigator's judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Systolic blood pressure | — |
Secondary
| Measure | Time frame |
|---|---|
| Diastolic blood pressure HDL-cholesterol (HDL-C), LDL-cholesterol (LDL-C), hs-CRP Subjective evaluation questionnaire | — |
Countries
Japan
Contacts
Public ContactShigeru Imai
CROee.INC Evidence Division
Outcome results
None listed