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Trial record 67 of 727 for:    Area Under Curve AND Bioavailability

Evaluation of Increased Absorption of a Curcumin Emulsion (BIOCURC) in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT04103788
Recruitment Status : Completed
First Posted : September 25, 2019
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
ESM Technologies, LLC

Brief Summary:
This study is intended to evaluate the comparative effects of direct analysis of serum samples versus pre-treatment with enzymatic hydrolysis in split samples obtained from dosing with a highly absorbed curcumin emulsion product that is commercially available as BIOCURC.

Condition or disease Intervention/treatment Phase
Bioavailability Dietary Supplement: 95% Curcuminoid Powder Dietary Supplement: BIOCURC Not Applicable

Detailed Description:
When curcumin is absorbed by the body, it is primarily found in the bloodstream as curcumin glucuronide (C-gluc) and curcumin sulfate (C-SO4) metabolites. Traditionally bioavailability studies have performed an enzymatic hydrolysis pre-treatment of serum samples with both a glucuronidase and a sulfatase enzyme in order to produce free curcumin for analysis via HPLC. In subsequent years, standards have become available for the metabolites (C-gluc & C-SO4) that make it possible to determine these compound levels directly in serum samples using HPLC-MS-MS. Initial pilot work had indicated that enzymatic hydrolysis was producing falsely elevated results for bioavailability. We wanted to evaluate this in a more formal setting.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: open-label, crossover
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation of Increased Absorption of a Curcumin Emulsion (BIOCURC) in Healthy Volunteers Either Following Enzymatic Hydrolysis Pre-Treatment or Direct Analysis of Split Serum Samples
Actual Study Start Date : March 27, 2018
Actual Primary Completion Date : April 14, 2018
Actual Study Completion Date : December 13, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arm Intervention/treatment
Active Comparator: 95% Curcuminoid Powder
Curcumin powder standardized to >95% curcuminoids, single dose, used to determine standard absorptivity of unformulated powder.
Dietary Supplement: 95% Curcuminoid Powder
1200 mg curcuminoids

Experimental: BIOCURC
Highly absorbed curcumin emulsion, single dose, used to produce serum samples for analytical comparison of sample preparation methodologies.
Dietary Supplement: BIOCURC
400 mg curcuminoids




Primary Outcome Measures :
  1. Comparative effect of differing serum sample preparation methodologies on curcumin absorption levels [ Time Frame: 6 hours ]
    direct analysis versus enzymatic hydrolysis pre-treatment of serum samples to determine Area Under the Curve (AUC) levels in ng-hr/mL of curcumin glucuronide, curcumin sulfate, and free curcumin


Secondary Outcome Measures :
  1. Enhanced absorption of BIOCURC compared to standard 95% curcumin powder [ Time Frame: 6 hours ]
    direct analysis of experimental treatment versus active comparator serum samples to determine Area Under the Curve (AUC) levels in ng-hr/mL curcumin glucuronide, curcumin sulfate, and free curcumin



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or Female subjects must be 21-75 years of age at the time of screening.

    a. Female subjects must agree to use one of the following medically acceptable contraceptive methods from the Screening visit (unless otherwise stated) through the End of Study (EOS) visit. Acceptable methods include: abstinence, same-sex partner, double barrier (condom, diaphragm, or cervical cap with spermicidal foam, gel, or cream), bilateral tubal ligation, hysterectomy, bilateral oophorectomy; intrauterine device (IUD) with or without hormones in place or hormonal contraception (oral, injectable, implantable, transdermal, or vaginal) used consecutively for at least 3 months prior to the Screening visit; vasectomized partner or bilateral insertion of Essure® implants for at least 6 months prior to the Screening visit; or postmenopausal status with amenorrhea (no menses) for at least 1 year prior to the Screening visit.

  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.
  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 BIOCURC® 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. 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.
  8. Subject has a history or positive test result of HIV, hepatitis B or hepatitis C.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04103788


Locations
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United States, Missouri
QPS Bio-Kinetic
Springfield, Missouri, United States, 65802
Sponsors and Collaborators
ESM Technologies, LLC
Investigators
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Study Director: Kevin J. Ruff, Ph.D. Stratum Nutrition

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: ESM Technologies, LLC
ClinicalTrials.gov Identifier: NCT04103788     History of Changes
Other Study ID Numbers: ESM-CLN#2018T01
First Posted: September 25, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ESM Technologies, LLC:
Bioavailability
Absorption
Additional relevant MeSH terms:
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Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action