NCT04382014

Pharmacokinetic Study on Three Formulations of Curcumin With Different Carriers

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Université de Sherbrooke · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Curcumin is a molecule soluble in fat. It has multiple health benefits. Indeed, it has anti-inflammatory and anti-oxidant properties. Curcumin could play a role in preventing diseases such as cancer, inflammatory, cardiovascular and neurodegenerative diseases. Omega-3 fatty acids are also important for good health, as they have positive effects on the cardiovascular and neurological systems. However, curcumin is poorly absorbed by the body when provided in supplements. In order to improve curcumin's absorption, a natural health product that combines curcumin and omega-3 fatty acids has been developped. The goal of this project is therefore to determine the absorption of curcumin when administered in combination with omega-3 fatty acids esterified in monoacylglycerol (MAG). This combination will be compared with a curcumin extract alone or in rice oil. A pharmacokinetic study will be carried out for each of the formulations. Pharmacokinetics (PK) is defined as monitoring the blood concentrations of curcumin over a 24-hour period after taking one of the three different supplements.

Detailed description

15 men and 15 women in good health conditions will be recruited for this project. The study has a randomized double-blinded crossover design with three treatments that include an equal dosage of curcumin as follows : * 400 mg of curcumin extract, * 400 mg of curcumin in rice oil, * 400 mg of curcumin extract + 1.5 g omega-3 in MAG form. For each of the above listed products, a natural product number (NPN) was requested to Health Canada and these number are currently pending. Each participant will consume each of the three treatments in a random order with a minimum of 7 days washout phase between both treatments. Blood samples will be collected at time 0, 1, 2, 3, 4, 5, 6, 8, 10, and 24h (10 blood samples per participant per treatment) after taking the single dose intake. A questionnaire will allow documenting side effects throughout the study period. The analyses will be performed by ultra-high-performance liquid chromatography couples to a quadrupole mass spectrometer (UPLC/MS/MS). Samples will be analyzed in a blinded manner such that the student and research assistant will be blinded from the type of treatment and the time point they are analyzing. After performing all the analyses, sample identification will be decoded and pharmacokinetic data of the curcuminoids in each of the treatments will be plotted on a plasma concentration vs time curve. The parameters below will be calculated: * Area under the curve (AUC) 0-24h (bioavailability); * Area under the curve (AUC) 0-6h (absorption); * Maximum concentration (Cmax); * Time to reach the maximum concentration (Tmax); * Half-life (if available).

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	MAG fish oil + Curcumin OR Rice bran oil + Curcumin OR Curcumin extract	The intervention is a randomized double blind cross over design testing the pharmacokinetics of 1) curcumin combined with MAG fish oil as a carrier, 2) curcumin combined with rice bran oil as a carrier, and 3) curcumin extract. Treatments are randomly assigned on days 1, 8 and 15 of the clinical study. Blood samples will be collected at time 0, 1, 2, 3, 4, 5, 6, 8, 10 and 24h after taking the supplement. Each participant will perform all three treatments, with a minimum of 7 days between treatments. A questionnaire will document the side effects felt by participants.

Timeline

• Start date: 2020-06-01
• Primary completion: 2020-10-01
• Completion: 2021-03-01
• First posted: 2020-05-11
• Last updated: 2020-05-11

Locations

1 site across 1 country: Canada