Healthy
Conditions
Keywords
Curcumin, Pharmacokinetic
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.
Interventions
DIETARY_SUPPLEMENTProprietary Curcumin Formulation
DIETARY_SUPPLEMENTUnformulated Comparator Curcumin Product
Sponsors
Boston Biopharm, Inc.
KGK Science Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Curcumin AUC | Time 0 to 48 hours | Area Under the Curve |
| Curcumin Cmax | Time 0 to 48 hours | Maximum Concentration |
| Curcumin Tmax | Time 0 to 48 hours | Time until maximum concentration |
Other
| Measure | Time frame |
|---|---|
| Changes in blood creatinine levels | Time 0 to 48 hours |
| Changes in blood AST levels | Time 0 to 48 hours |
| Incidence of adverse events | 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 |
| Changes in blood ALT levels | 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 |
Countries
Canada
Outcome results
None listed