A Study to Compare the Pharmacokinetic Profile of a Proprietary Curcumin Forumulation to a Comparator Curcumin Product

Study Overview
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Brief Summary
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This study is investigating the pharmacokinetic profile (i.e. the way the product is processed by the body) of a proprietary curcumin formulation compared to an unformulated curcumin product. Subjects will take a single dose of either the proprietary formulation or comparator product and the blood levels of curcumin and curcumin metabolites will be measured over a period of 48 hours.

Official Title
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A Randomized, Double-blind, Crossover Study to Compare the Pharmacokinetic Profile of a Proprietary Curcumin Formulation to a Comparator Curcumin Product

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Proprietary Curcumin Formulation
* Dietary Supplement: Unformulated Comparator Curcumin Product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and females 18-45 years of age If female, subject is not of child bearing potential, which is defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation) OR Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include: Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System) Double-barrier method Non-hormonal intrauterine devices Vasectomy of partner BMI 18-29.9 kg/m2 (±1 kg/m2) Healthy as determined by laboratory results and medical history Agrees to maintain current level of physical activity throughout the study Agree to avoid using black or white pepper, turmeric, curcumin or curry in the preparation of food for 7 days prior to randomization and throughout the study period. Agree to avoid Indian and Thai cuisines for the period of the study Agree to avoid food with yellow dye #E100 Agrees to avoid alcohol, caffeine 12 hours and grapefruit and grapefruit juice 48 hours prior to baseline and each subsequent clinic visit Agrees to consume only low polyphenols in the diet (nutritionists will counsel on high polyphenol fruits, vegetables to avoid, wine, beer, supplements, herbal extracts, and whole-grain based foods) 3 days prior to baseline and on test days (meal options and lists of foods to avoid will be provided to subjects by nutritionists) Has given voluntary, written, informed consent to participate in the study Exclusion Criteria: BMI ≥ 30 kg/m2 Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial. Unstable medical conditions as determined by the Qualified Investigator Use of natural health products containing turmeric or curcumin within 7 days prior to randomization and during the course of the study Use of St Johns Wort 3 weeks prior to baseline and during the study Subjects who are smokers Subjects with current or history of gastrointestinal problems or disease Metabolic, endocrine, or chronic diseases Immunocompromised individuals such as subjects that have undergone organ transplantation or subjects diagnosed with human immunodeficiency virus (HIV) Clinically significant abnormal lab results at screening (e.g. AST and/or ALT > 2 x ULN, and/or bilirubin > 2 x ULN) will be assessed by the Qualified Investigator Subjects who have planned surgery during the course of the trial History of or current diagnosis of any cancer (except for successfully treated basal cell carcinoma) diagnosed less than 5 years prior to screening. Subjects with cancer in full remission more than 5 years of diagnosis are acceptable. History of gallbladder issues, hyperacidity, gastric/duodenal ulcers. Prior use of prescription H2 blocker, proton pump inhibitor or blood sugar-lowering agents Use of blood pressure medication Subjects on restrictive dietary regimens Blood donation in the last 2 months History of blood/bleeding disorders or taking prescription blood thinners or anti-platelet therapy Alcohol abuse (>2 standard alcoholic drinks per day) or drug abuse within the past 6 months Use of medical marijuana Clinically significant abnormal laboratory results at screening Participation in a clinical research trial within 30 days prior to randomization Allergy or sensitivity to study supplement ingredients or to any food or beverage provided during the study Individuals who are cognitively impaired and/or who are unable to give informed consent Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dosing Sequence 1<br>Proprietary Curcumin Formulation administered first, Unformulated Comparator Curcumin Product administered second | Dietary Supplement: Proprietary Curcumin Formulation<br> <br> Dietary Supplement: Unformulated Comparator Curcumin Product<br> <br> |
| Experimental: Dosing Sequence 2<br>Unformulated Comparator Curcumin Product administered first, Proprietary Curcumin Formulation administered second | Dietary Supplement: Proprietary Curcumin Formulation<br> <br> Dietary Supplement: Unformulated Comparator Curcumin Product<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Curcumin AUC | Area Under the Curve | Time 0 to 48 hours | 
| Curcumin Cmax | Maximum Concentration | Time 0 to 48 hours | 
| Curcumin Tmax | Time until maximum concentration | Time 0 to 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Curcumin, Pharmacokinetic