Status:
COMPLETED
Bioavailability Evaluation of CurQ+ Curcumin Formulation
Lead Sponsor:
ESM Technologies, LLC
Collaborating Sponsors:
The University of Texas Health Science Center, Houston
Conditions:
Bioavailability
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This study is intended to evaluate how significantly a proprietary curcumin formulation (curQ+®) results in greater bioavailability compared to 95% curcumin extract over a 6-hour time period following...
Detailed Description
This study is intended to evaluate how significantly a proprietary curcumin formulation (curQ+®) results in greater bioavailability compared to 95% curcumin extract over a 6-hour time period following...
Eligibility Criteria
Inclusion
- Male or Female subjects must be 18-75 years of age at the time of Screening.
- 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 and for 14 days prior to screening.
- 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, and sunflower 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.
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06177483
Start Date
March 1 2024
End Date
September 10 2024
Last Update
September 19 2024
Active Locations (1)
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1
University of Texas Health Center
Houston, Texas, United States, 77030