Bioavailability
Conditions
Keywords
Bioavailability, Pharmacokinetics
Brief summary
This study is intended to evaluate how significantly a proprietary curcumin formulation (curQ+® or liposomal curcumin) results in greater GI absorption compared to 95% curcumin extract over a 6-hour time period following a single oral dose in healthy men & women.
Detailed description
This study is intended to evaluate how significantly a proprietary curcumin formulation (curQ+® or liposomal curcumin) results in greater GI absorption compared to 95% curcumin extract over a 6-hour time period following a single oral dose in healthy men & women. Absorption enhancement 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+® & liposomal curcumin formulations.
Interventions
DIETARY_SUPPLEMENT95% curcumin extract powder
95% curcumin extract powder
DIETARY_SUPPLEMENTcurQ+ curcumin formulation
curQ+ curcumin formulation
DIETARY_SUPPLEMENTliposomal curcumin formulation
liquid liposomal curcumin formulation
Sponsors
ESM Technologies, LLC
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
Open label - all are aware of intervention assignment
Intervention model description
Randomized, Parallel group absorption study
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absorption of curcumin as measured in serum via Liquid Chromatography Tandem Mass Spectrometry (LC/MS/MS) | 6 hours | The difference between the absorption of curcumin from the formulations curQ+ or liposomal curcumin versus 95% curcumin powder as measured in serum via Liquid Chromatography Tandem Mass Spectrometry (LC/MS/MS) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKaren L Posey, PhD
UTHealth
Outcome results
None listed