Clinical Trials Directory

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

TypeNameDescription
DIETARY_SUPPLEMENT95% Curcuminoid Powder1200 mg curcuminoids
DIETARY_SUPPLEMENTCurQ+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.