Skip to main content
OpenTrials
Completed

NCT Number: NCT02474953

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

KGK Synergize Inc.

London, Ontario, N6A 5R8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proprietary Curcumin Formulation

Dietary Supplement

Unformulated Comparator Curcumin Product

Dietary Supplement

Primary outcomes

  1. Curcumin AUC

    Time frame: Time 0 to 48 hours

    Area Under the Curve

  2. Curcumin Cmax

    Time frame: Time 0 to 48 hours

    Maximum Concentration

  3. Curcumin Tmax

    Time frame: Time 0 to 48 hours

    Time until maximum concentration

Other outcomes

  1. Incidence of adverse events

    Time frame: Time 0 to 48 hours

  2. Changes in blood CBC levels

    Time frame: Time 0 to 48 hours

  3. Changes in blood electrolyte levels

    Time frame: Time 0 to 48 hours

  4. Changes in blood creatinine levels

    Time frame: Time 0 to 48 hours

  5. Changes in blood AST levels

    Time frame: Time 0 to 48 hours

  6. Changes in blood ALT levels

    Time frame: Time 0 to 48 hours

  7. Changes in blood GGT levels

    Time frame: Time 0 to 48 hours

  8. Changes in blood bilirubin levels

    Time frame: Time 0 to 48 hours

Sponsors and collaborators

Lead sponsor

KGK Science Inc.

Industry

Collaborators

  • Boston Biopharm, Inc.

Registry information

Official study title

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

Acronym: 15PCHB

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 18, 2015
Registry last updated
Sep 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.