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

Completed · Not applicable

Conditions studied: Bioavailability

In brief

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.

Key facts

Study ID: NCT04103788
Run by: ESM Technologies, LLC
People needed: 10
Starts: 2018-03-27
Expected to finish: 2018-12-13
Last updated by the study team: 2021-12-13

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

Subject is currently receiving therapy with remission-inducing drugs (i.e. methotrexate, TNF biologics, etc.), immunosuppressive drugs (i.e. corticosteroids, transplantation medications, etc.).
Subjects must not have taken turmeric- or curcumin-containing dietary supplements within 14 days prior to screening evaluation.
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.).
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.
Subject's body weight is greater than 300 pounds (136.1 kg) at the time of Screening.
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.
Pregnant and/or breastfeeding women, or women who intend to become pregnant during the course of the study.
Subject has a history or positive test result of HIV, hepatitis B or hepatitis C.

Where it is running

QPS Bio-Kinetic — Springfield, Missouri, United States

Full record on ClinicalTrials.gov

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