Comparing the Pharmacological Profile of Formulations Containing Omega 3 Fatty Acids

September 11, 2023 updated by: Factors Group of Nutritional Companies Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Burnaby, British Columbia, Canada, V3N4S9
        • ISURA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RxOmega-3 soft gels (Enteric)

Each participant receives their treatment of RxOmega-3 soft gel (Enteric) capsules at a total dose of 1260 mg Omega-3 Fatty Acids. Treatments are consumed with a glass of water (approx. 200 mL), followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at time points 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours.

Participants are asked to arrive after an overnight fast (at least 9hrs). Each participant acts as their own control; there is no separate control group. A washout period of at least 14 days between each treatment will be used.

Adverse events are recorded throughout the study by direct questioning.
Dietary supplement: RxOmega-3 soft gels (Enteric)
A maximum single dose of 1260 mg Omega-3 Fatty Acids: Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA)
Experimental: Omega-3 Complete soft gels (Non-Enteric)

Each participant receives their treatment of Omega-3 Complete soft gel (Non-Enteric) capsules at a total dose of 1260 mg Omega-3 Fatty Acids. Treatments are consumed with a glass of water (approx. 200 mL), followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at time points 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours.

Participants are asked to arrive after an overnight fast (at least 9hrs). Each participant acts as their own control; there is no separate control group. A washout period of at least 14 days between each treatment will be used.

Adverse events are recorded throughout the study by direct questioning.
Dietary supplement: 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)
Experimental: Omega-3 LipoMicel® soft gels

Each participant receives their treatment of Omega-3 LipoMicel® soft gel capsules at a total dose of 1260 mg Omega-3 Fatty Acids. Treatments are consumed with a glass of water (approx. 200 mL), followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at time points 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours.

Participants are asked to arrive after an overnight fast (at least 9hrs). Each participant acts as their own control; there is no separate control group. A washout period of at least 14 days between each treatment will be used.

Adverse events are recorded throughout the study by direct questioning.
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC: the area under the concentration-time curve
Time Frame: 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.
0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)
Cmax: maximum plasma concentration
Time Frame: 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.
0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)
Tmax: the time point of maximum plasma concentration
Time Frame: 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.
0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects on blood lipid parameters
Time Frame: 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.
0 (Baseline; pre-dose), 3, 6, 12, 24, 48, 72, 96, 120 hours post-dose
Changes in blood lipid concentrations
Time Frame: 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.
0 (Baseline; pre-dose), 3, 6, 12, 24, 48, 72, 96, 120 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Factors Group of Nutritional Companies Inc.

Investigators

  • Principal Investigator: Julia Solnier, PhD, ISURA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

May 24, 2022

First Submitted That Met QC Criteria

May 24, 2022

First Posted (Actual)

May 27, 2022

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2021-10-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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