Viewing Study NCT04382014



Ignite Creation Date: 2024-05-06 @ 2:39 PM
Last Modification Date: 2024-10-26 @ 1:34 PM
Study NCT ID: NCT04382014
Status: UNKNOWN
Last Update Posted: 2020-05-11
First Post: 2020-05-06

Brief Title: Pharmacokinetic Study on Three Formulations of Curcumin With Different Carriers
Sponsor: Université de Sherbrooke
Organization: Université de Sherbrooke

Study Overview

Official Title: Pharmacokinetic Study on Three Formulations of Curcumin With Different Carriers
Status: UNKNOWN
Status Verified Date: 2020-05
Last Known Status: NOT_YET_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 curcumins 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 15 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 UPLCMSMS 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None