Metabolism of Bioactive Dietary Polyphenol Preparation (BDPP)
Study Phase: Phase 1
Recruitment Status: Recruiting
Start Date: January 19, 2021
End Date: August 01, 2024
Inclusion Criteria:
- Male or female aged 18-55 years;
- Body max index (BMI) <30;
- Participants must have a level of understanding of the English language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process.
Exclusion Criteria:
- Any psychiatric diagnosis as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
- Subjects who meet criteria for a substance or alcohol use disorder in the past 2 years;
- Female participants who are pregnant or nursing or plan to become pregnant;
- Any unstable medical illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease); endocrinologic, neurologic, immunologic, or hematologic disease;
- Clinically significant abnormalities of laboratory tests, physical examination, or electrocardiogram;
- Any diagnosed inflammatory or autoimmune disorder, including but not limited to rheumatoid arthritis, ankylosing spondylitis, myositis, vasculitis, systemic lupus erythematosus, Sjogren's Syndrome, or scleroderma;
- Any use of medication or nutritional supplement known to affect inflammation, including but not limited to non-steroidal anti-inflammatory agents (NSAIDs), aspirin, acetaminophen, COX-2 selective inhibitors, omega-3 fatty acids, turmeric extract, ginger extract, vitamin E, and "Devil's claw";
- Individuals using supplements known to affect polyphenol levels;
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.