← Back to Search

Omega-3 Fatty Acids

Omega-3 LipoMicel® soft gels for Pharmacokinetics

N/A
Waitlist Available
Led By Julia Solnier, PhD
Research Sponsored by Factors Group of Nutritional Companies Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 21-65
healthy, good physical condition
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 (baseline; pre-dose), 3, 6, 12, 24, 48, 72, 96, 120 hours post-dose
Awards & highlights

Study 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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 (baseline; pre-dose), 3, 6, 12, 24, 48, 72, 96, 120 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 (baseline; pre-dose), 3, 6, 12, 24, 48, 72, 96, 120 hours post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC: the area under the concentration-time curve
Cmax: maximum plasma concentration
Tmax: the time point of maximum plasma concentration
Secondary outcome measures
Body Weight Changes
Effects on blood lipid parameters

Trial Design

3Treatment groups
Experimental Treatment
Group I: RxOmega-3 soft gels (Enteric)Experimental Treatment1 Intervention
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.
Group II: Omega-3 LipoMicel® soft gelsExperimental Treatment1 Intervention
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.
Group III: Omega-3 Complete soft gels (Non-Enteric)Experimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omega-3 LipoMicel® soft gels
2022
N/A
~20
RxOmega-3 soft gels (Enteric)
2022
N/A
~20
Omega-3 Complete soft gels (Non-Enteric)
2022
N/A
~20

Find a Location

Who is running the clinical trial?

Factors Group of Nutritional Companies Inc.Lead Sponsor
7 Previous Clinical Trials
219 Total Patients Enrolled
2 Trials studying Pharmacokinetics
22 Patients Enrolled for Pharmacokinetics
Julia Solnier, PhDPrincipal InvestigatorIsura
1 Previous Clinical Trials
16 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Comparing the Pharmacological Profile of Formulations Containing Omega 3 Fatty Acids
2022. "Comparing the Pharmacological Profile of Formulations Containing Omega 3 Fatty Acids". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05394701.
~4 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top