Status:
COMPLETED
Metabolism of Bioactive Dietary Polyphenol Preparation (BDPP)
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Healthy Control
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study will characterize the clinical pharmacology of a select bioactive polyphenol-rich preparation (Bioactive Dietary Polyphenol Preparation, BDPP) comprised of a select Concord grape juice (CGJ...
Detailed Description
Stress-related disorders, such as depression, are some of the most disabling human illnesses worldwide. Most currently available treatments for depression target neurochemical or neurobiological mecha...
Eligibility Criteria
Inclusion
- 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.
- Including Spanish speaking participants
Exclusion
- 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.
Key Trial Info
Start Date :
January 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2024
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04421079
Start Date
January 19 2021
End Date
December 2 2024
Last Update
March 3 2025
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029