- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05349032
Assessing the Bioavailability of Leading Phytonutrient Products
April 21, 2022 updated by: Epiceutical Labs
This study will primarily test various phytonutrient-based supplements to see which gets absorbed into the body the best.
The study will secondarily look at inflammatory markers in the urine to determine any change.
Study Overview
Detailed Description
This study will primarily test various phytonutrient-based supplements to see which gets absorbed into the body the best.
120 mg of curcumin from brands Meriva, CurcElite, Lonvida, UltraCur, NovaSol.
The study will secondarily look at inflammatory markers in the urine to determine any change.
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: David Roberts, MPH
- Phone Number: 810777687
- Email: research@epiceuticallabs.com
Study Locations
-
-
Virginia
-
Charlottesville, Virginia, United States, 22902
- Recruiting
- David Roberts
-
Contact:
- David Roberts, MPH
- Phone Number: 434-981-8629
- Email: droberts@brocelite.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 47 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Age and gender
Exclusion Criteria:
- Cannot take any phytonutrient or curcumin supplement five days prior to commencement.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Meriva
120 mg of curcumin in Meriva.
|
Oral supplement
|
Other: Longvida
120 mg of curcumin Longvida.
|
Oral supplement
|
Other: NovaSol
120 mg of curcumin NovaSol
|
Oral supplement
|
Other: CurcElite
120 mg of curcumin CurcElite
|
Oral supplement
|
Other: UltaCur
120 mg of curcumin Ultracur
|
Oral supplement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bioavailability
Time Frame: 0, 1, 2, 4, and 12 hours
|
Blood Plasma
|
0, 1, 2, 4, and 12 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2022
Primary Completion (Anticipated)
April 30, 2022
Study Completion (Anticipated)
June 1, 2022
Study Registration Dates
First Submitted
April 21, 2022
First Submitted That Met QC Criteria
April 21, 2022
First Posted (Actual)
April 27, 2022
Study Record Updates
Last Update Posted (Actual)
April 27, 2022
Last Update Submitted That Met QC Criteria
April 21, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Inflammation
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Curcumin
Other Study ID Numbers
- 101 (Hamilton Integrated Research Ethics Board)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
Blood plasma and urine samples will be collected for five different times over five different supplements.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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