Bioavailability Evaluation of CurQ+ Curcumin Formulation

ESM Technologies

Status: Completed

Conditions: Bioavailability

Treatments: Dietary Supplement: curQ+ curcumin formulation; Dietary Supplement: 95% curcumin extract powder

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06177483

ESM-CLN#2023T02

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male or Female subjects must be 18-75 years of age at the time of Screening.
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 and for 14 days prior to screening.
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

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, and sunflower 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

95% curcumin extract powder

Active Comparator group

Description:

1,265 mg of 95% curcumin extract (minimum 1,200 mg of curcuminoids) in three #0 vegetarian capsules as a single oral dose

Treatment:

Dietary Supplement: 95% curcumin extract powder

curQ+ curcumin formulation

Experimental group

Description:

2,860 mg of curQ+® containing a total of 400 mg of curcuminoids in six #0 vegetarian capsules as a single oral dose

Treatment:

Dietary Supplement: curQ+ curcumin formulation