Status:
UNKNOWN
Pharmacokinetic Study on Three Formulations of Coenzyme Q10 With Different Carriers
Lead Sponsor:
Mélanie Plourde
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
NA
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 triphosp...
Detailed Description
Benefits and importance of CoQ10 for the human health: Coenzyme Q10 (CoQ10) is an endogenously produced lipid-soluble molecule of the human organism that is considered an essential component of the m...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04035525
Start Date
March 4 2020
End Date
August 31 2020
Last Update
March 20 2020
Active Locations (1)
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1
Centre de Recherche sur le Vieillissement
Sherbrooke, Quebec, Canada, J1H 4C4