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

NCT04103788 | Completed

• 1 other identifier: ESM-CLN#2018T01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Bioavailability

Keywords

Bioavailability; Absorption

Outcome Measures

Primary Outcomes (1)

• Comparative effect of differing serum sample preparation methodologies on curcumin absorption levels

  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

  6 hours

Secondary Outcomes (1)

• Enhanced absorption of BIOCURC compared to standard 95% curcumin powder

  6 hours

Study Arms (2)

95% Curcuminoid Powder

ACTIVE COMPARATOR

Curcumin powder standardized to \>95% curcuminoids, single dose, used to determine standard absorptivity of unformulated powder.

Dietary Supplement: 95% Curcuminoid Powder

CurQ+

EXPERIMENTAL

Highly absorbed curcumin coconut oil emulsion, single dose, used to produce serum samples for analytical comparison of sample preparation methodologies.

Dietary Supplement: CurQ+

Interventions

95% Curcuminoid Powder DIETARY_SUPPLEMENT

1200 mg curcuminoids

95% Curcuminoid Powder

CurQ+ DIETARY_SUPPLEMENT

400 mg curcuminoids + coconut oil + polysorbate

CurQ+

Eligibility Criteria

• Age: 21 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 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.
• 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.
• 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. 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.
• Subject has a history or positive test result of HIV, hepatitis B or hepatitis C.

Sponsors & Collaborators

• ESM Technologies, LLC: lead

Study Sites (1)

QPS Bio-Kinetic

Springfield, Missouri, 65802, United States

Location

Related Publications (1)

• Stohs SJ, Chen CYO, Preuss HG, Ray SD, Bucci LR, Ji J, Ruff KJ. The fallacy of enzymatic hydrolysis for the determination of bioactive curcumin in plasma samples as an indication of bioavailability: a comparative study. BMC Complement Altern Med. 2019 Nov 4;19(1):293. doi: 10.1186/s12906-019-2699-x.

  PMID: 31684927 RESULT

Related Links

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

Study Officials

• Kevin J. Ruff, Ph.D.

  Stratum Nutrition

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: open-label, crossover

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 25, 2019
• Study Start: March 27, 2018
• Primary Completion: April 14, 2018
• Study Completion: December 13, 2018
• Last Updated: December 13, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)