HealthyNCT04382014
Pharmacokinetic Study on Three Formulations of Curcumin With Different Carriers
A study testing MAG fish oil + Curcumin OR Rice bran oil + Curcumin OR Curcumin extract in people with Healthy, run by Université de Sherbrooke at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MAG fish oil + Curcumin OR Rice bran oil + Curcumin OR Curcumin extract
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2020to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men or women between 18 and 50 years old (inclusive).
- Body mass index between 18,5 and 34,9 at the selection visit (inclusive).
- Normal to moderately high lipidemia (total cholesterol ≤ 240 mg / dl; LDL ≤ 160 mg / dl; Triglyceride ≤ 199 mg / dl).
- Women of child bearing potential must accept to use an effective contraceptive method for the duration of the study.
Who cannot join
- Allergy to fish or seafood.
- Special diet like a vegetarian or vegan diet.
- Tobacco.
- History of current or past alcohol and / or drug abuse.
- Current or past performance athlete.
- Malnutrition (assessed by albumin, hemoglobin and blood lipid levels).
Show all 24Show fewer
- People consuming omega 3 fatty acid or curcumin supplements for more than 6 months.
- Medication affecting fat absorption (ie, Orlistat, Alli, etc.).
- Medication which interferes with the metabolization of the medication (ie, anticoagulants like coumadin or warfarin, aspirin is not an exclusion criterion (Watson et al, 2009))
- Medication which affects lipid metabolism (ie, all types of drugs to lower cholesterol or triglycerides).
- Medication which curcumin interacts with : angiotensin II blockers (losartan, valsartan), β-blockers (talinolol, celiprolol), calcium channels blockers (nifedipine), 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase (HMG CoA) reductase inhibitors (rosuvastatin), antineoplastic agents (docetaxel, etoposide, tamoxifen, everolimus, sirolimus), antibiotics (norfloxacin), antidepressant (midazolam), sulfonamides (sulfasalazine), antidiabetics (gliclazide).
- Pregnant women or nursing women.
- Menopause or pre-menopause with amenorrhea > 6 months.
- Systemic disease: vasculitis, Lupus Erythrocyte Disseminated (SLE), sarcoidosis, cancer (except if in remission for more than 10 years and without cerebral involvement), uncompensated hypothyroidism, vitamin B12 deficiency not supplemented and / or complicated, diabetes, severe renal insufficiency.
- Abnormal liver, kidney or thyroid function; these conditions will not exclude a patient if he / she has been stabilized on treatment for at least 3 months and there has been no recent change in his / her medication.
- Cardiac event or recent major surgery (<6 months).
- History of thrombosis or haemorrhagic diathesis.
- Malabsorption disease such as pancreatitis, Crohn's disease or has had bariatric surgery.
- Neurodegenerative disease (Parkinson disease).
- Genetic disorder (Down syndrome).
- Known psychiatric history: schizophrenia, psychotic disorders, major affective disorder (bipolar disorder and major depression <5 years), panic disorder, Compulsive Obsessive Compulsive Disorder (OCD).
- Neurological disorder (Epilepsy, cerebral trauma with loss of consciousness, subarachnoid hemorrhage).
- Person who has donated blood or had significant blood loss in the 30 days prior to the start of the study.
- Not available to perform the 3 treatments.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de Recherche sur le Vieillissement
Sherbrooke, Quebec, J1H 4C4
Melanie Plourde, PhD, 819-780-2220 ext. 45664, melanie.plourde2@usherbrooke.ca
About this study
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.
Read the 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
- Being tested
- MAG fish oil + Curcumin OR Rice bran oil + Curcumin OR Curcumin extract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAG fish oil + Curcumin OR Rice bran oil + Curcumin OR Curcumin extractDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| MAG fish oil + Curcumin | Experimental | The participant will arrive fasted at he research center. After installing a catheter and drawing 5 mL of blood, the participants will be given one of the active comparator or the treatment. The choice of the treatment/comparator will be random. In this arm, the participant will receive 1 dose of 1,5 g MAG fish oil + 400 mg curcumin. The participant will consume this unique dose with a standardized breakfast. There will thereafter be blood sample collection over 24 h to evaluate the level of curcumin in the plasma and a side effect questionnaire will be administered to monitor side effects. Receives: Dietary Supplement: MAG fish oil + Curcumin OR Rice bran oil + Curcumin OR Curcumin extract |
| Rice bran oil + Curcumin | Active comparator | The participant will arrive fasted at he research center. After installing a catheter and drawing 5 mL of blood, the participants will be given one of the active comparator or the treatment. The choice of the treatment/comparator will be random. In this arm, the participant will receive 1 dose of rice bran oil + 400 mg curcumin. The participant will consume this unique dose with a standardized breakfast. There will thereafter be blood sample collection over 24 h to evaluate the level of curcumin in the plasma and a side effect questionnaire will be administered to monitor side effects. Receives: Dietary Supplement: MAG fish oil + Curcumin OR Rice bran oil + Curcumin OR Curcumin extract |
| Curcumin extract | Active comparator | The participant will arrive fasted at he research center. After installing a catheter and drawing 5 mL of blood, the participants will be given one of the active comparator or the treatment. The choice of the treatment/comparator will be random. In this arm, the participant will receive 1 dose of 400 mg curcumin. The participant will consume this unique dose with a standardized breakfast. There will thereafter be blood sample collection over 24 h to evaluate the level of curcumin in the plasma and a side effect questionnaire will be administered to monitor side effects. Receives: Dietary Supplement: MAG fish oil + Curcumin OR Rice bran oil + Curcumin OR Curcumin extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the bioavailability of curcumin in combination with fish oil, rice oil or alone: Calculating the area under the curve (AUC) 0-48h as the first parameter of the PK
Plasma curcumin levels will be measured by ultra-performance liquid chromatography (UPLC), each sample being performed randomly blindly. After UPLC analyzes, area under the curve (AUC) 0-48 hours will be calculated, as the first parameter of the PK. Statistical analyzes will then be performed on this PK parameter.
Measured: Treatments are randomly assigned on days 1, 8 and 15 of the clinical study. UPLC analyzes will be measured on plasma from blood samples collected at time 0, 1, 2, 3, 4, 5, 6, 8, 10 and 24 hours post-treatment.
Determine the bioavailability of curcumin in combination with fish oil, rice oil or alone: Calculating the AUC 0-6h (absorption study) as the second parameter of the PK
Plasma curcumin levels will be measured by ultra-performance liquid chromatography (UPLC), each sample being performed randomly blindly. After UPLC analyzes, AUC 0-6 hours (absorption study) will be calculated, as the second parameter of the PK. Statistical analyzes will then be performed on this PK parameter.
Measured: Treatments are randomly assigned on days 1, 8 and 15 of the clinical study. UPLC analyzes will be measured on plasma from blood samples collected at time 0, 1, 2, 3, 4, 5, 6, 8, 10 and 24 hours post-treatment.
Determine the bioavailability of curcumin in combination with fish oil, rice oil or alone: Calculating the maximum concentration as the third parameter of the PK
Plasma curcumin levels will be measured by ultra-performance liquid chromatography (UPLC), each sample being performed randomly blindly. After UPLC analyzes, maximum concentration will be calculated, as the third parameter of the PK. Statistical analyzes will then be performed on this PK parameter.
Measured: Treatments are randomly assigned on days 1, 8 and 15 of the clinical study. UPLC analyzes will be measured on plasma from blood samples collected at time 0, 1, 2, 3, 4, 5, 6, 8, 10 and 24 hours post-treatment.
Determine the bioavailability of curcumin in combination with fish oil, rice oil or alone: Calculating the time when the maximum concentration is reached, as the fourth parameter of the PK
Plasma curcumin levels will be measured by ultra-performance liquid chromatography (UPLC), each sample being performed randomly blindly. After UPLC analyzes, time when the maximum concentration is reached will be calculated, as the fourth parameter of the PK. Statistical analyzes will then be performed on this PK parameter.
Measured: Treatments are randomly assigned on days 1, 8 and 15 of the clinical study. UPLC analyzes will be measured on plasma from blood samples collected at time 0, 1, 2, 3, 4, 5, 6, 8, 10 and 24 hours post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start1 Jun 2020 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind controlled-randomized pharmacokinetic (PK) study with crossover design (15 men and 15 women), with a minimum of 6 days between treatments
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mélanie Plourde, Université de Sherbrooke
- Investigators
- Melanie Plourde, PhD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382014
- Sponsor's protocol ID
- MaxSimil + curcumin
- Status last verified
- May 2020
- First submitted
- 6 May 2020
- Last updated
- 11 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study on Three Formulations of Curcumin With Different Carriers
- ClinicalTrials.gov ID
- NCT04382014
- Acronym / sponsor ID
- MaxSimil + curcumin
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 11 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Double-blind controlled-randomized pharmacokinetic (PK) study with crossover design (15 men and 15 women), with a minimum of 6 days between treatments
| Arm | Type | Receives |
|---|---|---|
| MAG fish oil + Curcumin | Experimental | Dietary Supplement: MAG fish oil + Curcumin OR Rice bran oil + Curcumin OR Curcumin extractThe participant will arrive fasted at he research center. After installing a catheter and drawing 5 mL of blood, the participants will be given one of the active comparator or the treatment. The choice of the treatment/comparator will be random. In this arm, the participant will receive 1 dose of 1,5 g MAG fish oil + 400 mg curcumin. The participant will consume this unique dose with a standardized breakfast. There will thereafter be blood sample collection over 24 h to evaluate the level of curcumin in the plasma and a side effect questionnaire will be administered to monitor side effects. |
| Rice bran oil + Curcumin | Active comparator | Dietary Supplement: MAG fish oil + Curcumin OR Rice bran oil + Curcumin OR Curcumin extractThe participant will arrive fasted at he research center. After installing a catheter and drawing 5 mL of blood, the participants will be given one of the active comparator or the treatment. The choice of the treatment/comparator will be random. In this arm, the participant will receive 1 dose of rice bran oil + 400 mg curcumin. The participant will consume this unique dose with a standardized breakfast. There will thereafter be blood sample collection over 24 h to evaluate the level of curcumin in the plasma and a side effect questionnaire will be administered to monitor side effects. |
| Curcumin extract | Active comparator | Dietary Supplement: MAG fish oil + Curcumin OR Rice bran oil + Curcumin OR Curcumin extractThe participant will arrive fasted at he research center. After installing a catheter and drawing 5 mL of blood, the participants will be given one of the active comparator or the treatment. The choice of the treatment/comparator will be random. In this arm, the participant will receive 1 dose of 400 mg curcumin. The participant will consume this unique dose with a standardized breakfast. There will thereafter be blood sample collection over 24 h to evaluate the level of curcumin in the plasma and a side effect questionnaire will be administered to monitor side effects. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men or women between 18 and 50 years old (inclusive).
- Body mass index between 18,5 and 34,9 at the selection visit (inclusive).
- Normal to moderately high lipidemia (total cholesterol ≤ 240 mg / dl; LDL ≤ 160 mg / dl; Triglyceride ≤ 199 mg / dl).
- Women of child bearing potential must accept to use an effective contraceptive method for the duration of the study.
Key exclusion criteria (24 listed)
- Allergy to fish or seafood.
- Special diet like a vegetarian or vegan diet.
- Tobacco.
- History of current or past alcohol and / or drug abuse.
- Current or past performance athlete.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAG fish oil + Curcumin OR Rice bran oil + Curcumin OR Curcumin extractThe 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. | Dietary supplement | Curcumin extract, MAG fish oil + Curcumin, Rice bran oil + Curcumin |
Primary outcome
Determine the bioavailability of curcumin in combination with fish oil, rice oil or alone: Calculating the area under the curve (AUC) 0-48h as the first parameter of the PK
Time frame: Treatments are randomly assigned on days 1, 8 and 15 of the clinical study. UPLC analyzes will be measured on plasma from blood samples collected at time 0, 1, 2, 3, 4, 5, 6, 8, 10 and 24 hours post-treatment.
Plasma curcumin levels will be measured by ultra-performance liquid chromatography (UPLC), each sample being performed randomly blindly. After UPLC analyzes, area under the curve (AUC) 0-48 hours will be calculated, as the first parameter of the PK. Statistical analyzes will then be performed on this PK parameter.
Determine the bioavailability of curcumin in combination with fish oil, rice oil or alone: Calculating the AUC 0-6h (absorption study) as the second parameter of the PK
Time frame: Treatments are randomly assigned on days 1, 8 and 15 of the clinical study. UPLC analyzes will be measured on plasma from blood samples collected at time 0, 1, 2, 3, 4, 5, 6, 8, 10 and 24 hours post-treatment.
Plasma curcumin levels will be measured by ultra-performance liquid chromatography (UPLC), each sample being performed randomly blindly. After UPLC analyzes, AUC 0-6 hours (absorption study) will be calculated, as the second parameter of the PK. Statistical analyzes will then be performed on this PK parameter.
Determine the bioavailability of curcumin in combination with fish oil, rice oil or alone: Calculating the maximum concentration as the third parameter of the PK
Time frame: Treatments are randomly assigned on days 1, 8 and 15 of the clinical study. UPLC analyzes will be measured on plasma from blood samples collected at time 0, 1, 2, 3, 4, 5, 6, 8, 10 and 24 hours post-treatment.
Plasma curcumin levels will be measured by ultra-performance liquid chromatography (UPLC), each sample being performed randomly blindly. After UPLC analyzes, maximum concentration will be calculated, as the third parameter of the PK. Statistical analyzes will then be performed on this PK parameter.
Determine the bioavailability of curcumin in combination with fish oil, rice oil or alone: Calculating the time when the maximum concentration is reached, as the fourth parameter of the PK
Time frame: Treatments are randomly assigned on days 1, 8 and 15 of the clinical study. UPLC analyzes will be measured on plasma from blood samples collected at time 0, 1, 2, 3, 4, 5, 6, 8, 10 and 24 hours post-treatment.
Plasma curcumin levels will be measured by ultra-performance liquid chromatography (UPLC), each sample being performed randomly blindly. After UPLC analyzes, time when the maximum concentration is reached will be calculated, as the fourth parameter of the PK. Statistical analyzes will then be performed on this PK parameter.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melanie Plourde, PhD principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAG fish oil + Curcumin OR Rice bran oil + Curcumin OR Curcumin extract in people with Healthy, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melanie Plourde, PhD (819-780-2220 ext. 45664, melanie.plourde2@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the bioavailability of curcumin in combination with fish oil, rice oil or alone: Calculating the area under the curve (AUC) 0-48h as the first parameter of the PK (time frame: Treatments are randomly assigned on days 1, 8 and 15 of the clinical study. UPLC analyzes will be measured on plasma from blood samples collected at time 0, 1, 2, 3, 4, 5, 6, 8, 10 and 24 hours post-treatment.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2020.