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CompletedNCT04103788Updated Dec 13, 2021

Evaluation of Increased Absorption of a Curcumin Emulsion (CurQ+) in Healthy Volunteers

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

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Mar 2018, registered Sep 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
21 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Bioavailability

Keywords

  • Bioavailability
  • Absorption
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
21 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. 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.

  2. 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.
  3. Subjects must be available for and willing to attend all evaluation visits.
  4. Subjects must be able and willing to give informed consent.
  5. 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

Exclusion Criteria:

  1. Subject is currently receiving therapy with remission-inducing drugs (i.e. methotrexate, TNF biologics, etc.), immunosuppressive drugs (i.e. corticosteroids, transplantation medications, etc.).
  2. Subjects must not have taken turmeric- or curcumin-containing dietary supplements within 14 days prior to screening evaluation.
  3. Subject has been diagnosed with any clinically significant confounding metabolic disease or condition that would interfere with the study evaluation, as judged by the clinical investigator (slow or fast metabolism resulting from hypo- or hyper-thyroidism, Cushing's Syndrome, Diabetes (except for fully resolved gestational diabetes), etc.) or any conditions that would affect absorption in the GI tract (i.e. inflammatory bowel disease, celiac disease, Behçet's Syndrome, systemic sclerosis, etc.).
  4. Subject has known allergy to any of the investigational products, including but not limited to turmeric, curcumin, coconut or coconut oil. If any subject becomes sensitive during the study, they will immediately be excluded from continuing in the study.
  5. Subject's body weight is greater than 300 pounds (136.1 kg) at the time of Screening.
  6. Subject is involved in any other research study involving an investigational product (drug, device or biologic) or a new application of an approved product, within 30 days of the first baseline evaluation.
  7. Pregnant and/or breastfeeding women, or women who intend to become pregnant during the course of the study.
  8. Subject has a history or positive test result of HIV, hepatitis B or hepatitis C.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Active comparator
    95% Curcuminoid Powder

    Curcumin powder standardized to \>95% curcuminoids, single dose, used to determine standard absorptivity of unformulated powder.

    Dietary Supplement: 95% Curcuminoid Powder

  • Experimental
    CurQ+

    Highly absorbed curcumin coconut oil emulsion, single dose, used to produce serum samples for analytical comparison of sample preparation methodologies.

    Dietary Supplement: CurQ+

Interventions

  • Dietary supplement95% Curcuminoid Powder

    1200 mg curcuminoids

  • Dietary supplementCurQ+

    400 mg curcuminoids + coconut oil + polysorbate

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

07

Study locations

1 site
  • QPS Bio-Kinetic
    Springfield, Missouri 65802, United States
08

References and documents

Publications

  • 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. PubMed 31684927 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04103788
Lead sponsor
ESM Technologies, LLC
Responsible party
Sponsor
First posted
Sep 25, 2019
Start date
Mar 27, 2018
Primary completion
Apr 14, 2018
Completion
Dec 13, 2018
Last update
Dec 13, 2021

Study contacts

Kevin J. Ruff, Ph.D.
study director · Stratum Nutrition

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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