Pharmacokinetics
Conditions
Keywords
Bioavailability, Pharmacokinetics, Omega-3 fatty acids, Fish Oil
Brief summary
The primary objective of this study is to investigate the uptake/gastrointestinal absorption of fatty acids in healthy adult volunteers by using enteric coated and non-enteric coated soft capsules containing omega 3 fatty acids. Pharmacokinetic parameters such as AUC and Cmax, as well as any adverse events are recorded. As secondary objective, the short-term effects of Omega-3 supplementation on blood lipid parameters in healthy volunteers are evaluated using a Cholestech LDX analyzer to measure cholesterol and related lipids.
Interventions
DIETARY_SUPPLEMENTOmega-3 LipoMicel® soft gels
A maximum single dose of 1260 mg Omega-3 Fatty Acids: Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA)
DIETARY_SUPPLEMENTRxOmega-3 soft gels (Enteric)
A maximum single dose of 1260 mg Omega-3 Fatty Acids: Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA)
DIETARY_SUPPLEMENTOmega-3 Complete soft gels (Non-Enteric)
A maximum single dose of 1260 mg Omega-3 Fatty Acids: Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA)
Sponsors
Factors Group of Nutritional Companies Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 21-65 * healthy, good physical condition
Exclusion criteria
* Pregnancy or breast-feeding * Gastrointestinal conditions * Acute or chronic liver disease * Acute or chronic kidney disease * Acute or chronic cardiovascular disease * Allergy or Intolerance to gluten * Allergy or Intolerance to fish or shellfish * Use of medications (e.g., anticoagulants/ blood thinners such as warfarin; blood lipid-lowering agents such as statins) * Use of Fish oil supplements * Use of any form of nicotine or tobacco * Alcohol and substance abuse history * Participation in another investigational study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC: the area under the concentration-time curve | 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose) | To determine the gastrointestinal absorption of orally ingested omega-3 fatty acids in enteric coated soft gel capsules in healthy adult volunteers and compare the Area under the plasma concentration versus time curve (AUC) with that of non-enteric coated soft capsules containing omega 3 fatty acids. |
| Cmax: maximum plasma concentration | 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose) | To determine the gastrointestinal absorption of orally ingested omega-3 fatty acids in enteric coated soft gel capsules in healthy adult volunteers and compare the Peak Plasma Concentration (Cmax) with that of non-enteric coated soft capsules containing omega 3 fatty acids. |
| Tmax: the time point of maximum plasma concentration | 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose) | To determine the gastrointestinal absorption of orally ingested omega-3 fatty acids in enteric coated soft gel capsules in healthy adult volunteers and compare the time point of maximum plasma concentration (Tmax) with that of non-enteric coated soft capsules containing omega 3 fatty acids. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effects on blood lipid parameters | 0 (Baseline; pre-dose), 3, 6, 12, 24, 48, 72, 96, 120 hours post-dose | To evaluate the short-term effects of orally ingested omega-3 fatty acids on cholesterol levels in healthy volunteers by using a Cholestech LDX analyzer. |
| Changes in blood lipid concentrations | 0 (Baseline; pre-dose), 3, 6, 12, 24, 48, 72, 96, 120 hours post-dose | To evaluate changes in blood lipid concentrations of orally ingested omega-3 fatty acids in healthy volunteers by using a Cholestech LDX analyzer. |
Countries
Canada
Outcome results
None listed