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

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ClinicalTrials.gov Identifier: NCT02474953
Recruitment Status : Completed
First Posted : June 18, 2015
Last Update Posted : September 23, 2015
Sponsor:
Collaborator:
Boston BioPharm
Information provided by (Responsible Party):
KGK Science Inc.

Tracking Information
First Submitted Date  ICMJE June 10, 2015
First Posted Date  ICMJE June 18, 2015
Last Update Posted Date September 23, 2015
Study Start Date  ICMJE April 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2015)
  • Curcumin AUC [ Time Frame: Time 0 to 48 hours ]
    Area Under the Curve
  • Curcumin Cmax [ Time Frame: Time 0 to 48 hours ]
    Maximum Concentration
  • Curcumin Tmax [ Time Frame: Time 0 to 48 hours ]
    Time until maximum concentration
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02474953 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: June 17, 2015)
  • Incidence of adverse events [ Time Frame: Time 0 to 48 hours ]
  • Changes in blood CBC levels [ Time Frame: Time 0 to 48 hours ]
  • Changes in blood electrolyte levels [ Time Frame: Time 0 to 48 hours ]
  • Changes in blood creatinine levels [ Time Frame: Time 0 to 48 hours ]
  • Changes in blood AST levels [ Time Frame: Time 0 to 48 hours ]
  • Changes in blood ALT levels [ Time Frame: Time 0 to 48 hours ]
  • Changes in blood GGT levels [ Time Frame: Time 0 to 48 hours ]
  • Changes in blood bilirubin levels [ Time Frame: Time 0 to 48 hours ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study to Compare the Pharmacokinetic Profile of a Proprietary Curcumin Forumulation to a Comparator Curcumin Product
Official Title  ICMJE A Randomized, Double-blind, Crossover Study to Compare the Pharmacokinetic Profile of a Proprietary Curcumin Formulation to a Comparator Curcumin Product
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Dietary Supplement: Proprietary Curcumin Formulation
  • Dietary Supplement: Unformulated Comparator Curcumin Product
Study Arms  ICMJE
  • Experimental: Dosing Sequence 1
    Proprietary Curcumin Formulation administered first, Unformulated Comparator Curcumin Product administered second
    Interventions:
    • 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
    Interventions:
    • Dietary Supplement: Proprietary Curcumin Formulation
    • Dietary Supplement: Unformulated Comparator Curcumin Product
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 17, 2015)
12
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02474953
Other Study ID Numbers  ICMJE 15PCHB
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party KGK Science Inc.
Study Sponsor  ICMJE KGK Science Inc.
Collaborators  ICMJE Boston BioPharm
Investigators  ICMJE
Principal Investigator: Tetyana Pelipyagina, MD KGK Science Inc.
PRS Account KGK Science Inc.
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP