Pharmacokinetic Study on Three Formulations of Curcumin With Different Carriers

NCT04382014 | Unknown

• 1 other identifier: MaxSimil + curcumin
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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.

Study Arms (3)

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.

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.

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.

Dietary Supplement: MAG fish oil + Curcumin OR Rice bran oil + Curcumin OR Curcumin extract

Interventions

MAG fish oil + Curcumin OR Rice bran oil + Curcumin OR Curcumin extract DIETARY_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.

Curcumin extract; MAG fish oil + Curcumin; Rice bran oil + Curcumin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: 15 men and 15 women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• People consuming omega 3 fatty acid or curcumin supplements for more than 6 months.
• Medication affecting fat absorption (ie, Orlistat, Alli, etc.).
• 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).

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Centre de Recherche sur le Vieillissement

Sherbrooke, Quebec, J1H 4C4, Canada

Location

MeSH Terms

Interventions

Curcumin; Rice Bran Oil

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Melanie Plourde, PhD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melanie Plourde, PhD

CONTACT

819-780-2220; melanie.plourde2@usherbrooke.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Neither the participant nor the research nurse will know the administration order of the different treatments administered. All plasma samples collected during the research project will be anonymized. Also, it will not be possible to identify the participant by his name since a number will be assigned to him. The code key linking the participant's name to his number will be stored, with access restricted to those designated by the principal investigator. The data file is also protected by a password.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Double-blind controlled-randomized pharmacokinetic (PK) study with crossover design (15 men and 15 women), with a minimum of 6 days between treatments

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 11, 2020
• Study Start: June 1, 2020
• Primary Completion: October 1, 2020
• Study Completion: March 1, 2021
• Last Updated: May 11, 2020

Record last verified: 2020-05

Locations

CA (1)