Healthy adult
Conditions
Interventions
Intake of dark chocolate at three times the recommended daily amount, for 4 weeks
Intake of placebo chocolate at three times the recommended daily amount, for 4 weeks
Sponsors
EP Mediate Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Males and females aged 20 to 64 years at the time of obtaining consent 2) Ambulatory blood pressure values at the time of the pre-test that meet one of the following criteria: a) Higher blood pressure (Systolic blood pressure 130-159 mmHg or diastolic blood pressure 85-99 mmHg) b) Normal blood pressure 3) Subjects who fully understand the purpose and details of the study and voluntarily consent to participate
Exclusion criteria
Exclusion criteria: 1) Subjects who had exhibited abnormal clinical laboratory values in the past and were judged to be unsuitable for participation in the study 2) Subjects with a current or past medical history of serious diseases such as brain disorders, malignant tumors, immune disorders, kidney disorders, liver disorders, cardiovascular disorders, respiratory disorders, endocrine disorders, or other metabolic disorders 3) Subjects with food allergies 4) Subjects with chronic internal medical conditions requiring continuous treatment (whether topical or oral), those currently undergoing treatment for chronic internal diseases, or those with a history of serious illness requiring medication 5) Subjects with significantly abnormal values deviating from the reference range in physical measurements, physical examinations, or clinical laboratory tests prior to intake 6) Subjects who work in shifts or late at night, and have irregular daily routines or eating habits 7) Subjects who have participated in other clinical studies within one month prior to the start of this study, are currently participating, or wish to participate in such studies during the study period 8) Subjects who plan to become pregnant or breastfeed during the study period 9) Subjects who cannot ingest chocolate daily 10) Subjects who consume foods, beverages, or supplements high in cacao flavanols and cannot discontinue their consumption during the study period 11) Subjects with a current or past medical history of drug or alcohol dependence 12) Heavy alcohol drinkers (average pure alcohol intake of approximately 41 g/day or more) 13) Subjects who plan to travel overseas during the study period 14) Subjects who are judged to be unsuitable based on their responses to the background survey 15) Subjects who are judged unsuitable for the study by the principal investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hematologic test, Blood biochemistry test, Urine test, Blood pressure/pulsation, Weight/body mass index, Medical Interview (before and 2, 4 weeks after intake and 2 weeks after the end of intake period), Adverse events (thorough the study) | — |
Countries
Japan
Contacts
Public ContactHiroyasu Shimada
EP Mediate Co., Ltd. Development Department Trial Planning Section
Outcome results
None listed