A Study on the Effect of Food Containing Plant Extract on Platelet Aggregation -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study
- Conditions
- o
- Registration Number
- JPRN-UMIN000042940
- Lead Sponsor
- KSO Corporation
- Brief Summary
Statistically significant difference was confirmed in the primary outcome.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Not provided
(1)Subjects who have a chronic disease and regularly use medications. (2) Subjects who cannot stop using supplements, and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) during the test periods. (3) Subjects with a history and/or presence of serious diseases (e. g., liver disease, kidney disease, heart disease, respiratory disease, endocrine disease, and/or metabolic disease). (4) Subjects who had a history of digestive diseases and/or underwent a surgical procedure for digestive disease. (5) Subjects who declared allergic reactions to foods. (6) Subjects who had excessive alcohol intake of > 60 g/day of pure alcohol equivalent or habit of drinking not less than five days a week. (7)Subjects with a history of and/or current drug addiction and/or alcoholism. (8) Subjects unable to cease drinking for two days before each measurement. (9) Subjects who are shift workers and/or night-shift workers. (10) Subjects who were pregnant or planned to become pregnant or breastfeed during the study period. (11) Subjects who had donated over 200 mL of blood and/or blood components within the last one month prior to the current study or over 400 mL of blood and/or blood components within the three months prior to the current study. (12) Subjects who were planning to participate and/or had participated in other clinical studies within the month prior to the commencement of the current study. (13) Subjects who were judged as unsuitable for the current study by screening tests. (14) Subjects who were judged as unsuitable for the current study by the investigator for other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method platelet aggregation
- Secondary Outcome Measures
Name Time Method