A Study to Compare the Pharmacokinetic Profile of a Proprietary Curcumin Forumulation to a Comparator Curcumin Product (15PCHB)

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Proprietary Curcumin Formulation; Dietary supplement: Unformulated Comparator Curcumin Product

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5R8
      • KGK Synergize Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male and females 18-45 years of age

2. 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
3. BMI 18-29.9 kg/m2 (±1 kg/m2)
4. Healthy as determined by laboratory results and medical history
5. Agrees to maintain current level of physical activity throughout the study
6. 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.
7. Agree to avoid Indian and Thai cuisines for the period of the study
8. Agree to avoid food with yellow dye #E100
9. Agrees to avoid alcohol, caffeine 12 hours and grapefruit and grapefruit juice 48 hours prior to baseline and each subsequent clinic visit
10. 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)
11. Has given voluntary, written, informed consent to participate in the study

Exclusion Criteria:

1. BMI ≥ 30 kg/m2
2. Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial.
3. Unstable medical conditions as determined by the Qualified Investigator
4. Use of natural health products containing turmeric or curcumin within 7 days prior to randomization and during the course of the study
5. Use of St Johns Wort 3 weeks prior to baseline and during the study
6. Subjects who are smokers
7. Subjects with current or history of gastrointestinal problems or disease
8. Metabolic, endocrine, or chronic diseases
9. Immunocompromised individuals such as subjects that have undergone organ transplantation or subjects diagnosed with human immunodeficiency virus (HIV)
10. 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
11. Subjects who have planned surgery during the course of the trial
12. 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.
13. History of gallbladder issues, hyperacidity, gastric/duodenal ulcers.
14. Prior use of prescription H2 blocker, proton pump inhibitor or blood sugar-lowering agents
15. Use of blood pressure medication
16. Subjects on restrictive dietary regimens
17. Blood donation in the last 2 months
18. History of blood/bleeding disorders or taking prescription blood thinners or anti-platelet therapy
19. Alcohol abuse (>2 standard alcoholic drinks per day) or drug abuse within the past 6 months
20. Use of medical marijuana
21. Clinically significant abnormal laboratory results at screening
22. Participation in a clinical research trial within 30 days prior to randomization
23. Allergy or sensitivity to study supplement ingredients or to any food or beverage provided during the study
24. Individuals who are cognitively impaired and/or who are unable to give informed consent
25. 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dosing Sequence 1; Proprietary Curcumin Formulation administered first, Unformulated Comparator Curcumin Product administered second	Dietary supplement: Proprietary Curcumin Formulation; Dietary supplement: Unformulated Comparator Curcumin Product
Experimental: Dosing Sequence 2; Unformulated Comparator Curcumin Product administered first, Proprietary Curcumin Formulation administered second	Dietary supplement: Proprietary Curcumin Formulation; Dietary supplement: Unformulated Comparator Curcumin Product

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events	Time 0 to 48 hours
Changes in blood CBC levels	Time 0 to 48 hours
Changes in blood electrolyte levels	Time 0 to 48 hours
Changes in blood creatinine levels	Time 0 to 48 hours
Changes in blood AST levels	Time 0 to 48 hours
Changes in blood ALT levels	Time 0 to 48 hours
Changes in blood GGT levels	Time 0 to 48 hours
Changes in blood bilirubin levels	Time 0 to 48 hours

Collaborators and Investigators

• Sponsor: KGK Science Inc.
• Collaborators: Boston Biopharm, Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: June 10, 2015
• First Submitted That Met QC Criteria: June 17, 2015
• First Posted (Estimate): June 18, 2015

Study Record Updates

• Last Update Posted (Estimate): September 23, 2015
• Last Update Submitted That Met QC Criteria: September 22, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Pharmacokinetic; Curcumin
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: 15PCHB