Status:
UNKNOWN
Pharmacokinetic Study on Three Formulations of Curcumin With Different Carriers
Lead Sponsor:
Université de Sherbrooke
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
NA
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, ...
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 curcu...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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 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.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04382014
Start Date
June 1 2020
End Date
March 1 2021
Last Update
May 11 2020
Active Locations (1)
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1
Centre de Recherche sur le Vieillissement
Sherbrooke, Quebec, Canada, J1H 4C4