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

Healthy Clinical Trial

— 15PCHB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02474953
• Other study ID #: 15PCHB
• Status: Completed
• Phase: Phase 1
• First received: June 10, 2015
• Last updated: September 22, 2015
• Start date: April 2015
• Est. completion date: June 2015

Study information

• Verified date: September 2015
• Source: KGK Synergize Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Proprietary Curcumin Formulation

• Unformulated Comparator Curcumin Product

Locations

Country	Name	City	State
Canada	KGK Synergize Inc.	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
KGK Synergize Inc.	Boston BioPharm

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of adverse events		Time 0 to 48 hours	Yes
Other	Changes in blood CBC levels		Time 0 to 48 hours	Yes
Other	Changes in blood electrolyte levels		Time 0 to 48 hours	Yes
Other	Changes in blood creatinine levels		Time 0 to 48 hours	Yes
Other	Changes in blood AST levels		Time 0 to 48 hours	Yes
Other	Changes in blood ALT levels		Time 0 to 48 hours	Yes
Other	Changes in blood GGT levels		Time 0 to 48 hours	Yes
Other	Changes in blood bilirubin levels		Time 0 to 48 hours	Yes
Primary	Curcumin AUC	Area Under the Curve	Time 0 to 48 hours	No
Primary	Curcumin Cmax	Maximum Concentration	Time 0 to 48 hours	No
Primary	Curcumin Tmax	Time until maximum concentration	Time 0 to 48 hours	No