Pharmacokinetic Study on Three Formulations of Coenzyme Q10 With Different Carriers

NCT04035525 | Unknown

• 1 other identifier: MaxSimil and CoQ10
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Coenzyme Q10 (CoQ10) is a vitamin-like substance produced in all living human cells and naturally occurring in dietary sources. In addition to being responsible for the synthesis of adenosine triphosphate (ATP), a major source of energy, CoQ10 plays an essential role in maintaining several biochemical pathways of the human body: i) it acts as a primary scavenger of free radicals, and ii) it protects membranes phospholipids from peroxidation and membranes proteins and mitochondrial DNA from oxidative damage. Despite the potential impact that it has shown in a wide array of health conditions, CoQ10 has been reported to have a poor bioavailability in humans with a slow and incomplete absorption from the small intestine. This has been attributed to its high molecular weight, strongly lipophilic nature and low aqueous solubility. To overcome the above limitations, various drug delivery systems such as liposomes, polymeric nanoparticles, polymeric micelles, solid lipid nanoparticles, nanostructured lipid carriers, self-emulsifying systems, nanoemulsions and solid and aqueous dispersions have been explored and developed to improve the solubility, the absorption and the bioavailability of CoQ10. Even though these different technologies and delivery systems were able to improve the absorption of CoQ10 and increase its bioavailability, the carriers used to deliver CoQ10 are based on synthetic products with no health benefits attributed to them. Aligned with its mission and vision to provide its clients with wellness products, Biodroga Neutraceuticals Inc developped a CoQ10 product using its patented MaxSimil technology that is based on omega-3 fatty acids (EPA and DHA) and this health product will be serving as the carrier for CoQ10. Therefore, the aim of this study is to perform a PK study using a powder product of CoQ10 and a rice bran oil + CoQ10 forms as comparators to the MaxSimil® + CoQ10 omega-3 supplement and compare their bioavailability and side effects. In this context, a randomized crossover design with a minimum of 7 days of washout between treatments will be used. The MaxSimil® + CoQ10 formulation is anticipated to provide the best vehicle to increase the bioavailability of CoQ10 with the lowest side effects for the participants.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Determine the bioavailability of CoQ10 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 CoQ10 levels will be measured by high-performance liquid chromatography (HPLC), each sample being performed randomly blindly. After HPLC 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. HPLC analyzes will be measured on plasma from blood samples collected at time 0, 1, 2, 4, 5, 6, 8, 10, 12, 24 and 48 hours post-treatment.

• Determine the bioavailability of CoQ10 in combination with fish oil, rice oil or alone: Calculating the AUC 0-6h (absorption study) as the second parameter of the PK

  Plasma CoQ10 levels will be measured by high-performance liquid chromatography (HPLC), each sample being performed randomly blindly. After HPLC 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. HPLC analyzes will be measured on plasma from blood samples collected at time 0, 1, 2, 4, 5, 6, 8, 10, 12, 24 and 48 hours post-treatment.

• Determine the bioavailability of CoQ10 in combination with fish oil, rice oil or alone: Calculating the maximum concentration as the third parameter of the PK.

  Plasma CoQ10 levels will be measured by high-performance liquid chromatography (HPLC), each sample being performed randomly blindly. After HPLC 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. HPLC analyzes will be measured on plasma from blood samples collected at time 0, 1, 2, 4, 5, 6, 8, 10, 12, 24 and 48 hours post-treatment.

• Determine the bioavailability of CoQ10 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 CoQ10 levels will be measured by high-performance liquid chromatography (HPLC), each sample being performed randomly blindly. After HPLC 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. HPLC analyzes will be measured on plasma from blood samples collected at time 0, 1, 2, 4, 5, 6, 8, 10, 12, 24 and 48 hours post-treatment.

Study Arms (3)

MaxSimil® fish oil + CoQ10

EXPERIMENTAL

The participant will arrive fasted at he research center. After installing a cathether 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 g MaxSimil® fish oil + 200 mg CoQ10. 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 omega-3 fatty acids in the plasma and a side effect questionnaire will be administered to monitor side effects.

Dietary Supplement: MaxSimil® fish oil + CoQ10

Rice bran oil + CoQ10

ACTIVE COMPARATOR

The participant will arrive fasted at he research center. After installing a cathether 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 g rice bran oil + 200 mg CoQ10. 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 omega-3 fatty acids in the plasma and a side effect questionnaire will be administered to monitor side effects.

Dietary Supplement: Rice bran oil + CoQ10

CoQ10 as powder form

ACTIVE COMPARATOR

The participant will arrive fasted at he research center. After installing a cathether 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 g rice bran oil + 200 mg CoQ10. 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 omega-3 fatty acids in the plasma and a side effect questionnaire will be administered to monitor side effects.

Dietary Supplement: CoQ10 as powder form

Interventions

MaxSimil® fish oil + CoQ10 DIETARY_SUPPLEMENT

The intervention is a randomized double blind cross over design testing the pharmacokinetics of 1) CoQ10 combined with MaxSimil fish oil as a carrier, 2) CoQ10 combined with rice bran oil as a carrier, and 3) CoQ10 as a powder form. Treatments are randomly assigned on days 1, 8 and 15 of the clinical study. Blood samples will be collected at time 0, 1, 2, 4, 5, 6, 8, 10, 12, 24 and 48 hours. 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.

MaxSimil® fish oil + CoQ10

Rice bran oil + CoQ10 DIETARY_SUPPLEMENT

The intervention is a randomized double blind cross over design testing the pharmacokinetics of 1) CoQ10 combined with MaxSimil fish oil as a carrier, 2) CoQ10 combined with rice bran oil as a carrier, and 3) CoQ10 as a powder form. Treatments are randomly assigned on days 1, 8 and 15 of the clinical study. Blood samples will be collected at time 0, 1, 2, 4, 5, 6, 8, 10, 12, 24 and 48 hours. 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.

Rice bran oil + CoQ10

CoQ10 as powder form DIETARY_SUPPLEMENT

The intervention is a randomized double blind cross over design testing the pharmacokinetics of 1) CoQ10 combined with MaxSimil fish oil as a carrier, 2) CoQ10 combined with rice bran oil as a carrier, and 3) CoQ10 as a powder form. Treatments are randomly assigned on days 1, 8 and 15 of the clinical study. Blood samples will be collected at time 0, 1, 2, 4, 5, 6, 8, 10, 12, 24 and 48 hours. 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.

CoQ10 as powder form

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Man or woman between 18 and 50 years old (inclusive).
• Body mass index between 18,5 and 34,9 at the selection visit (inclusive).
• Normal to moderately elevated lipidemia (total cholesterol ≤ 240 mg / dl, LDL ≤ 160 mg / dl, TG ≤ 199 mg / dl).
• Woman of child bearing potential must accept to use an effective contraceptive method for the duration of the study.

You may not qualify if:

• Tobacco.
• Current or past performance athlete.
• Allergy to fish or seafood.
• Special diet like a fat-free, vegetarian or vegan diet.
• Menopause or pre-menopause with amenorrhea \> 6 months.
• History of current or past alcohol and / or drug abuse.
• Pregnant women or nursing women.
• Malnutrition (assessed by albumin, hemoglobin and blood lipid levels).
• 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, insufficiency severe renal.
• 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).
• Person with a history of thrombosis or haemorrhagic diathesis.
• People who have a malabsorption disease such as pancreatitis, Crohn's disease or who have had bariatric surgery.
• Hypo or hypertension.
• People consuming omega 3 fatty acid supplements for more than 6 months.

Sponsors & Collaborators

• Mélanie Plourde: lead

Study Sites (1)

Centre de Recherche sur le Vieillissement

Sherbrooke, Quebec, J1H 4C4, Canada

RECRUITING

MeSH Terms

Interventions

coenzyme Q10; Rice Bran Oil

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Central Study Contacts

Melanie Plourde, PhD

CONTACT

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

Sandrine Beaulieu, B.Sc.

CONTACT

819-780-2220; sandrine.beaulieu@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 i.e. 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: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

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: July 24, 2019
• First Posted: July 29, 2019
• Study Start: March 4, 2020
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: March 20, 2020

Record last verified: 2020-03

Locations

CA (1)