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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 95% Curcuminoid Powder | Active Comparator | Curcumin powder standardized to >95% curcuminoids, single dose, used to determine standard absorptivity of unformulated powder. |
|
| CurQ+ | Experimental | Highly absorbed curcumin coconut oil emulsion, single dose, used to produce serum samples for analytical comparison of sample preparation methodologies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 95% Curcuminoid Powder | Dietary Supplement | 1200 mg curcuminoids |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Comparative effect of differing serum sample preparation methodologies on curcumin absorption levels | direct analysis versus enzymatic hydrolysis pre-treatment of serum samples to determine Area Under the Curve (AUC) levels in ng-hr/mL of curcumin glucuronide, curcumin sulfate, and free curcumin | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Enhanced absorption of BIOCURC compared to standard 95% curcumin powder | direct analysis of experimental treatment versus active comparator serum samples to determine Area Under the Curve (AUC) levels in ng-hr/mL curcumin glucuronide, curcumin sulfate, and free curcumin | 6 hours |
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Inclusion Criteria:
Male or Female subjects must be 21-75 years of age at the time of screening.
a. Female subjects must agree to use one of the following medically acceptable contraceptive methods from the Screening visit (unless otherwise stated) through the End of Study (EOS) visit. Acceptable methods include: abstinence, same-sex partner, double barrier (condom, diaphragm, or cervical cap with spermicidal foam, gel, or cream), bilateral tubal ligation, hysterectomy, bilateral oophorectomy; intrauterine device (IUD) with or without hormones in place or hormonal contraception (oral, injectable, implantable, transdermal, or vaginal) used consecutively for at least 3 months prior to the Screening visit; vasectomized partner or bilateral insertion of Essure® implants for at least 6 months prior to the Screening visit; or postmenopausal status with amenorrhea (no menses) for at least 1 year prior to the Screening visit.
Subjects must be willing to refrain from consuming the spice turmeric or any dietary supplements containing turmeric or curcumin (except for the study products) throughout the entire study.
Subjects must be available for and willing to attend all evaluation visits.
Subjects must be able and willing to give informed consent.
Subjects participating in prior studies evaluating CurQ+® or curcumin can participate in the present study so long as they are not currently taking a curcumin containing supplement (including turmeric) and have not done so for 14 days prior to screening.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin J. Ruff, Ph.D. | Stratum Nutrition | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QPS Bio-Kinetic | Springfield | Missouri | 65802 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31684927 | Result | Stohs SJ, Chen CYO, Preuss HG, Ray SD, Bucci LR, Ji J, Ruff KJ. The fallacy of enzymatic hydrolysis for the determination of bioactive curcumin in plasma samples as an indication of bioavailability: a comparative study. BMC Complement Altern Med. 2019 Nov 4;19(1):293. doi: 10.1186/s12906-019-2699-x. |
| Label | URL |
|---|---|
| Evaluation of Increased Absorption of a Curcumin Emulsion (BIOCURC) in Healthy Volunteers | View source |
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open-label, crossover
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| CurQ+ |
| Dietary Supplement |
400 mg curcuminoids + coconut oil + polysorbate |
|