Comparing the Pharmacological Profile of Formulations Containing Omega 3 Fatty Acids

Pharmacokinetics Clinical Trial

Official title:

Comparing the Pharmacological Profile of Enteric Coated and Non-Enteric Coated Capsules Containing Omega 3 Fatty Acids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05394701
• Other study ID #: 2021-10-002
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2023
• Source: Factors Group of Nutritional Companies Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Dietary Supplement:
• Omega-3 LipoMicel® soft gels
A maximum single dose of 1260 mg Omega-3 Fatty Acids: Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA)
• RxOmega-3 soft gels (Enteric)
A maximum single dose of 1260 mg Omega-3 Fatty Acids: Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA)
• Omega-3 Complete soft gels (Non-Enteric)
A maximum single dose of 1260 mg Omega-3 Fatty Acids: Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA)

Locations

Country	Name	City	State
Canada	ISURA	Burnaby	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Factors Group of Nutritional Companies Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC: the area under the concentration-time curve	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.	0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)
Primary	Cmax: maximum plasma concentration	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.	0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)
Primary	Tmax: the time point of maximum plasma concentration	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.	0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)
Secondary	Effects on blood lipid parameters	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.	0 (Baseline; pre-dose), 3, 6, 12, 24, 48, 72, 96, 120 hours post-dose
Secondary	Changes in blood lipid concentrations	To evaluate changes in blood lipid concentrations of orally ingested omega-3 fatty acids in healthy volunteers by using a Cholestech LDX analyzer.	0 (Baseline; pre-dose), 3, 6, 12, 24, 48, 72, 96, 120 hours post-dose