Back to resultsAssessing the Bioavailability of Leading Phytonutrient Products
Primary Purpose
Inflammation
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Curcumin
Sponsored by
About this trial
This is an interventional basic science trial for Inflammation focused on measuring infalmmation, bioavailability
Eligibility Criteria
Inclusion Criteria:
- Age and gender
Exclusion Criteria:
- Cannot take any phytonutrient or curcumin supplement five days prior to commencement.
Sites / Locations
- David RobertsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Other
Other
Other
Other
Other
Arm Label
Meriva
Longvida
NovaSol
CurcElite
UltaCur
Arm Description
120 mg of curcumin in Meriva.
120 mg of curcumin Longvida.
120 mg of curcumin NovaSol
120 mg of curcumin CurcElite
120 mg of curcumin Ultracur
Outcomes
Primary Outcome Measures
Bioavailability
Blood Plasma
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05349032
Brief Title
Assessing the Bioavailability of Leading Phytonutrient Products
Official Title
Assessing the Bioavailability of Leading Phytonutrient Products
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Epiceutical Labs
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation
Keywords
infalmmation, bioavailability
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Meriva
Arm Type
Other
Arm Description
120 mg of curcumin in Meriva.
Arm Title
Longvida
Arm Type
Other
Arm Description
120 mg of curcumin Longvida.
Arm Title
NovaSol
Arm Type
Other
Arm Description
120 mg of curcumin NovaSol
Arm Title
CurcElite
Arm Type
Other
Arm Description
120 mg of curcumin CurcElite
Arm Title
UltaCur
Arm Type
Other
Arm Description
120 mg of curcumin Ultracur
Intervention Type
Dietary Supplement
Intervention Name(s)
Curcumin
Intervention Description
Oral supplement
Primary Outcome Measure Information:
Title
Bioavailability
Description
Blood Plasma
Time Frame
0, 1, 2, 4, and 12 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age and gender
Exclusion Criteria:
Cannot take any phytonutrient or curcumin supplement five days prior to commencement.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Roberts, MPH
Phone
810777687
Email
research@epiceuticallabs.com
Facility Information:
Facility Name
David Roberts
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Roberts, MPH
Phone
434-981-8629
Email
droberts@brocelite.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Blood plasma and urine samples will be collected for five different times over five different supplements.
Citations:
PubMed Identifier
30006023
Citation
Jamwal R. Bioavailable curcumin formulations: A review of pharmacokinetic studies in healthy volunteers. J Integr Med. 2018 Nov;16(6):367-374. doi: 10.1016/j.joim.2018.07.001. Epub 2018 Jul 4. Erratum In: J Integr Med. 2019 Jul;17(4):310.
Results Reference
result
Learn more about this trial
Assessing the Bioavailability of Leading Phytonutrient Products
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