Bioavailability Evaluation of curQ+ Curcumin Formulation

Study Overview
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Brief Summary
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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 a single oral dose in healthy men & women.

Detailed Description
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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 a single oral dose in healthy men & women. Bioavailability will be based upon producing the greatest plasma curcumin concentration (AUC). Secondarily, this study is intended to evaluate the safety and tolerability of the curQ+® curcumin formulation.

Official Title
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Bioavailability Evaluation of a Micellar Curcumin Formulation (curQ+) Versus 95% Curcumin Extract in Healthy Individuals

Conditions
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Bioavailability

Intervention / Treatment
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* Dietary Supplement: 95% curcumin extract powder
* Dietary Supplement: curQ+ curcumin formulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, Parallel group absorption study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 95% curcumin extract powder<br>1,265 mg of 95% curcumin extract (minimum 1,200 mg of curcuminoids) in three #0 vegetarian capsules as a single oral dose | Dietary Supplement: 95% curcumin extract powder<br>* 95% curcumin extract powder<br>|
| Experimental: curQ+ curcumin formulation<br>2,860 mg of curQ+® containing a total of 400 mg of curcuminoids in six #0 vegetarian capsules as a single oral dose | Dietary Supplement: curQ+ curcumin formulation<br>* curQ+ curcumin formulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absorption of curcumin | difference between the absorption of curQ+ versus 95% curcumin powder | 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioavailability, Pharmacokinetics