Recruiting

Coenzyme Q10

Sponsor:

Mélanie Plourde

Code:

NCT04035525

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

MaxSimil® fish oil + CoQ10

Rice bran oil + CoQ10

CoQ10 as powder form

Study Details

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

Study ID

NCT04035525

Start date

Mar 4, 2020

Status verified date

Mar, 2020

Completion date

Aug 31, 2020

Anticipated

Primary completion date

Aug 31, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Parkinson disease.
  • 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).
  • Epilepsy, cerebral trauma with loss of consciousness, subarachnoid hemorrhage.
  • Medication affecting fat absorption (ie, Orlistat, Alli, etc.), which interferes with the uptake of omega-3 fatty acids (ie, anticoagulants like coumadin, aspirin is not an exclusion criterion (Watson et al, 2009)), which affects lipid metabolism (ie, all types of drugs to lower cholesterol or triglycerides) or which affect CoQ10 blood levels (b-blockers and hypoglycemic agents).
  • 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 different treatments.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MaxSimil® fish oil + CoQ10

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.

active comparator: Rice bran oil + CoQ10

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.

active comparator: CoQ10 as powder form

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.

Interventions

MaxSimil® fish oil + CoQ10

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

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

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.

Primary outcome measure

  • 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Melanie Plourde, PhD

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

Sandrine Beaulieu, B.Sc.

819-780-2220sandrine.beaulieu@usherbrooke.ca

Locations

Centre de Recherche sur le Vieillissement

Recruiting

Sherbrooke, Quebec, Canada, J1H 4C4

Contacts

Melanie Plourde, PhD

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

Sandrine Beaulieu, B.Sc.

819-780-2220sandrine.beaulieu@usherbrooke.ca

Principal Investigator:

Melanie Plourde, PhD

More Information

Sponsor

Mélanie Plourde

Last update posted

Mar 20, 2020

Last verified

Mar, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mélanie Plourde on 2020-03-20.