Status:
COMPLETED
Evaluation of Increased Absorption of a Curcumin Emulsion (CurQ+) in Healthy Volunteers
Lead Sponsor:
ESM Technologies, LLC
Conditions:
Bioavailability
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief 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 absorb...
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 pe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2018
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04103788
Start Date
March 27 2018
End Date
December 13 2018
Last Update
December 13 2021
Active Locations (1)
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1
QPS Bio-Kinetic
Springfield, Missouri, United States, 65802