Bioavailability Evaluation of CurQ+ Curcumin Formulation

NCT06177483 | Completed DMC

• 1 other identifier: ESM-CLN#2023T02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 a single oral dose in healthy men \& women.

Conditions

Bioavailability

Keywords

Bioavailability, Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Absorption of curcumin

  difference between the absorption of curQ+ versus 95% curcumin powder

  6 hours

Study Arms (2)

95% curcumin extract powder

ACTIVE COMPARATOR

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

curQ+ curcumin formulation

EXPERIMENTAL

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

Interventions

95% curcumin extract powder DIETARY_SUPPLEMENT

95% curcumin extract powder

95% curcumin extract powder

curQ+ curcumin formulation DIETARY_SUPPLEMENT

curQ+ curcumin formulation

curQ+ curcumin formulation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ESM Technologies, LLC: lead
• The University of Texas Health Science Center, Houston: collaborator

Study Sites (1)

University of Texas Health Center

Houston, Texas, 77030, United States

Location

Study Officials

• Karen L Posey, PhD

  UTHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label - all are aware of intervention assignment
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Parallel group absorption study

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 20, 2023
• Study Start: March 1, 2024
• Primary Completion: April 5, 2024
• Study Completion: September 10, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)