PharmacokineticsNCT05394701
Comparing the Pharmacological Profile of Formulations Containing Omega 3 Fatty Acids
A study testing Omega-3 LipoMicel® soft gels, RxOmega-3 soft gels (Enteric) and Omega-3 Complete soft gels (Non-Enteric) in people with Pharmacokinetics, run by Factors Group of Nutritional Companies Inc. at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Omega-3 LipoMicel® soft gels, RxOmega-3 soft gels (Enteric) and Omega-3 Complete soft gels (Non-Enteric)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 21-65
- healthy, good physical condition
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pharmacokinetics
- Being tested
- Omega-3 LipoMicel® soft gels, RxOmega-3 soft gels (Enteric), Omega-3 Complete soft gels (Non-Enteric)
- Keywords
- Bioavailability, Pharmacokinetics, Omega-3 fatty acids, Fish Oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 LipoMicel® soft gelsDietary supplement
A maximum single dose of 1260 mg Omega-3 Fatty Acids: Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA)
RxOmega-3 soft gels (Enteric)Dietary supplement
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)Dietary supplement
A maximum single dose of 1260 mg Omega-3 Fatty Acids: Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA)
| Study group | Role | What they receive |
|---|---|---|
| RxOmega-3 soft gels (Enteric) | Experimental | 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. Receives: Dietary Supplement: RxOmega-3 soft gels (Enteric) |
| Omega-3 Complete soft gels (Non-Enteric) | Experimental | 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. Receives: Dietary Supplement: Omega-3 Complete soft gels (Non-Enteric) |
| Omega-3 LipoMicel® soft gels | Experimental | 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. Receives: Dietary Supplement: Omega-3 LipoMicel® soft gels |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)
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.
Measured: 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
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.
Measured: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)
Secondary outcomes (2)
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.
Measured: 0 (Baseline; pre-dose), 3, 6, 12, 24, 48, 72, 96, 120 hours post-dose
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.
Measured: 0 (Baseline; pre-dose), 3, 6, 12, 24, 48, 72, 96, 120 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start1 Mar 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Factors Group of Nutritional Companies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julia Solnier, PhD, Principal investigator, Isura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05394701
- Sponsor's protocol ID
- 2021-10-002
- Status last verified
- Sep 2023
- First submitted
- 24 May 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Pharmacological Profile of Enteric Coated and Non-Enteric Coated Capsules Containing Omega 3 Fatty Acids
- ClinicalTrials.gov ID
- NCT05394701
- Acronym / sponsor ID
- 2021-10-002
- Conditions
- Pharmacokinetics
- Keywords
- Bioavailability, Pharmacokinetics, Omega-3 fatty acids, Fish Oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Factors Group of Nutritional Companies Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RxOmega-3 soft gels (Enteric) | Experimental | Dietary Supplement: 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. |
| Omega-3 Complete soft gels (Non-Enteric) | Experimental | Dietary Supplement: 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. |
| Omega-3 LipoMicel® soft gels | Experimental | Dietary Supplement: Omega-3 LipoMicel® soft gelsEach 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 21-65
- healthy, good physical condition
Key exclusion criteria (12 listed)
- Pregnancy or breast-feeding
- Gastrointestinal conditions
- Acute or chronic liver disease
- Acute or chronic kidney disease
- Acute or chronic cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 LipoMicel® soft gelsA maximum single dose of 1260 mg Omega-3 Fatty Acids: Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) | Dietary supplement | Omega-3 LipoMicel® soft gels |
| RxOmega-3 soft gels (Enteric)A maximum single dose of 1260 mg Omega-3 Fatty Acids: Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) | Dietary supplement | RxOmega-3 soft gels (Enteric) |
| 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) | Dietary supplement | Omega-3 Complete soft gels (Non-Enteric) |
Primary outcome
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.
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.
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.
2 secondary outcomes
Effects on blood lipid parameters
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Solnier, PhD principal investigator
Isura
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 LipoMicel® soft gels, RxOmega-3 soft gels (Enteric) and Omega-3 Complete soft gels (Non-Enteric) in people with Pharmacokinetics, run by Factors Group of Nutritional Companies Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.