Status:
COMPLETED
Pharmacokinetics of Omega-3 Monoglycerides
Lead Sponsor:
Université de Sherbrooke
Conditions:
Healthy
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
North American diets have insufficient omega-3 fatty acid (n-3 FA) content. Consequently, they display low plasma concentrations of docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), the two ...
Detailed Description
The growing presence on the North American as well as European market of food products enriched with fish oil as a source of polyunsaturated fatty acids (PUFA) omega-3 in the diet requires evaluation ...
Eligibility Criteria
Inclusion
- Male or female aged 18-60 years (inclusive Body mass index between 19 and 30 kg / m² (inclusive) at the pre-selection visit Individuals had to refrain from participating to other clinical studies involving experimental drugs for at least 30 days.
- Female of childbearing potential must have an adequate contraception
Exclusion
- Person who consumed natural health products containing n-3 FAs in the last 6 months Allergy to fish or seafood Moderate-to-severe lipidemia (total cholesterol ≤ 240 mg/dl; LDL ≤ 160 mg/dl; Triglyceride ≤ 199 mg/dl) Tobacco or drug use Regular use of alcohol (females \> 10 drinks, males \> 14 drinks per week) Person who donated blood or had significant blood loss in the 56 days prior to study start Individuals with systolic blood pressure above 160 mmHg and diastolic blood pressure above 95 mmHg, or cardiac output at rest of less than 40 beats per minute or greater than 100 beats per minute.
- People presenting any cardiovascular, pulmonary, haematological, neurological, psychiatric, endocrine or immunological problems as well as any gastrointestinal tract, liver, kidney disease or other conditions that could affect the absorption of lipids Hypothyroidism Positive human chorionic gonadotropin, a hormone secreted during pregnancy
Key Trial Info
Start Date :
November 11 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04382027
Start Date
November 11 2010
End Date
May 5 2020
Last Update
May 11 2020
Active Locations (1)
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1
Centre de Recherche sur le Vieillissement
Sherbrooke, Quebec, Canada, J1H 4C4