Trials / Completed
CompletedNCT04103788
Evaluation of Increased Absorption of a Curcumin Emulsion (CurQ+) in Healthy Volunteers
Evaluation of Increased Absorption of a Curcumin Emulsion (CurQ+) in Healthy Volunteers Either Following Enzymatic Hydrolysis Pre-Treatment or Direct Analysis of Split Serum Samples
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- ESM Technologies, LLC · Industry
- Sex
- All
- Age
- 21 Years – 75 Years
- Healthy volunteers
- Accepted
Summary
This study is intended to evaluate the comparative effects of direct analysis of serum samples versus pre-treatment with enzymatic hydrolysis in split samples obtained from dosing with a highly absorbed curcumin emulsion product that is commercially available as BIOCURC.
Detailed description
When curcumin is absorbed by the body, it is primarily found in the bloodstream as curcumin glucuronide (C-gluc) and curcumin sulfate (C-SO4) metabolites. Traditionally bioavailability studies have performed an enzymatic hydrolysis pre-treatment of serum samples with both a glucuronidase and a sulfatase enzyme in order to produce free curcumin for analysis via HPLC. In subsequent years, standards have become available for the metabolites (C-gluc \& C-SO4) that make it possible to determine these compound levels directly in serum samples using HPLC-MS-MS. Initial pilot work had indicated that enzymatic hydrolysis was producing falsely elevated results for bioavailability. We wanted to evaluate this in a more formal setting.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | 95% Curcuminoid Powder | 1200 mg curcuminoids |
| DIETARY_SUPPLEMENT | CurQ+ | 400 mg curcuminoids + coconut oil + polysorbate |
Timeline
- Start date
- 2018-03-27
- Primary completion
- 2018-04-14
- Completion
- 2018-12-13
- First posted
- 2019-09-25
- Last updated
- 2021-12-13
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04103788. Inclusion in this directory is not an endorsement.