Bioavailability Evaluation of curQ+ Curcumin Formulation

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Bioavailability
• Intervention / Treatment: Dietary supplement: 95% curcumin extract powder; Dietary supplement: curQ+ curcumin formulation

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 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 95% curcumin extract powder; 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; 95% curcumin extract powder
Experimental: curQ+ curcumin formulation; 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; curQ+ curcumin formulation

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: ESM Technologies, LLC
• Collaborators: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Karen L Posey, PhD, UTHealth

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): April 5, 2024
• Study Completion (Estimated): July 30, 2024

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: December 11, 2023
• First Posted (Actual): December 20, 2023

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Bioavailability, Pharmacokinetics
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: ESM-CLN#2023T02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No