Comparing the Pharmacological Profile of Formulations Containing Omega 3 Fatty Acids

Sponsor

Factors Group of Nutritional Companies Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05394701

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pharmacokinetics	Dietary Supplement: Omega-3 LipoMicel® soft gels Dietary Supplement: RxOmega-3 soft gels (Enteric) Dietary Supplement: Omega-3 Complete soft gels (Non-Enteric)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Jul 31, 2022

Anticipated Study Completion Date :

Jul 31, 2022

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ISURA	Burnaby	British Columbia	Canada	V3N4S9

Sponsors and Collaborators

Factors Group of Nutritional Companies Inc.

Investigators

Principal Investigator: Julia Solnier, PhD, ISURA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Factors Group of Nutritional Companies Inc.

ClinicalTrials.gov Identifier:

NCT05394701

Other Study ID Numbers:

2021-10-002

First Posted:

May 27, 2022

Last Update Posted:

Jun 2, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Factors Group of Nutritional Companies Inc.

Study Results

No Results Posted as of Jun 2, 2022