Effect of Daily Ingestion of Lyophilized Powder of Solanum melongena on Blood Pressure for 8 weeks: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Finding Study
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000028785
- Lead Sponsor
- Hokkaido Information University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 52
Not provided
1.Subjects who are under physician's advice, treatment, and/or medication for hypertension, schizophrenia, depressive disorder, mania and/or neurologic disorder. 2.Subjects whose BMI is >=30 kg/m2. 3.Subjects who have (or suspected) secondary hypertension such as renovascular hypertension, renal parenchymal hypertension, primary aldosteronism, Cushing's syndrome, hypothyroidism, hyperthyroidism, etc. 4.Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 5.Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 6.Subjects with unusually high and/or low blood pressure and/or abnormal hematological data. 7.Subjects with severe anemia. 8.Pre- or post-menopausal women complaining of obvious physical changes. 9.Subjects who are at risk of having allergic reactions to drugs or foods especially based on Solanum melongena. 10.Subjects who regularly take medicine, functional foods, and/or supplements which would affect blood pressure and/or stress. 11.Heavy smokers, alcohol addicts or subjects with disordered lifestyle. 12.Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks (men and women), or blood components within 2 weeks (men and women), prior to the current study. 13.Pregnant or lactating women or women who expect to be pregnant during this study. 14.Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study. 15.Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hospital blood pressure at 4 and 8 weeks after beginning the ingestion of test food.
- Secondary Outcome Measures
Name Time Method Home blood pressure (morning and evening), salivary chromogranin A, salivary cortisol, salivary sIgA, VAS questionnaire assessed stress etc., POMS 2 full-length versions for adults, Pittsburgh Sleep Quality Index, Food Frequency Questionnaires