Clinical trial NCT02474953: A Study to Compare the Pharmacokinetic Profile of a Proprietary Curcumin Forumulation to a Comparator Curcumin Product
Official title: A Randomized, Double-blind, Crossover Study to Compare the Pharmacokinetic Profile of a Proprietary Curcumin Formulation to a Comparator Curcumin Product
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Curcumin
Pharmacokinetic
Lead sponsor: KGK Science Inc.
Sponsor class: INDUSTRY
Collaborators: name: Boston Biopharm, Inc.
First posted: 2015-06-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Curcumin AUC
timeFrame: Time 0 to 48 hours
measure: Curcumin Cmax
timeFrame: Time 0 to 48 hours
measure: Curcumin Tmax
timeFrame: Time 0 to 48 hours
Secondary outcomes:
Other outcomes:
measure: Incidence of adverse events
timeFrame: Time 0 to 48 hours
measure: Changes in blood CBC levels
timeFrame: Time 0 to 48 hours
measure: Changes in blood electrolyte levels
timeFrame: Time 0 to 48 hours
measure: Changes in blood creatinine levels
timeFrame: Time 0 to 48 hours
measure: Changes in blood AST levels
timeFrame: Time 0 to 48 hours
measure: Changes in blood ALT levels
timeFrame: Time 0 to 48 hours
measure: Changes in blood GGT levels
timeFrame: Time 0 to 48 hours
measure: Changes in blood bilirubin levels
timeFrame: Time 0 to 48 hours
Locations:
city: London
country: Canada
facility: KGK Synergize Inc.
state: Ontario
Study officials:
affiliation: KGK Science Inc.
name: Tetyana Pelipyagina, MD
role: PRINCIPAL_INVESTIGATOR
References: