An interventional study of 95% Curcuminoid Powder and CurQ+ in Bioavailability, sponsored by ESM Technologies, LLC. Completed at 1 site in United States. Open to participants aged 21 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-13.
Sponsored by ESM Technologies, LLC · Not applicable, Interventional, and Basic science
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.
ESM Technologies, LLC is the lead sponsor of 12 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Curcumin powder standardized to \>95% curcuminoids, single dose, used to determine standard absorptivity of unformulated powder.
Dietary Supplement: 95% Curcuminoid Powder
Highly absorbed curcumin coconut oil emulsion, single dose, used to produce serum samples for analytical comparison of sample preparation methodologies.
Dietary Supplement: CurQ+
1200 mg curcuminoids
400 mg curcuminoids + coconut oil + polysorbate
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
Time frame: 6 hours
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
Time frame: 6 hours
Plan to share: No
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
ESM Technologies, LLC