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NCT03735836
Effect of Fish Oil Monoglycerides on the Omega-3 Index
Phase 4 trial testing MAG-EPA/MAG-DHA omega-3 oils in Pharmacokinetic in Normal Population in 32 participants. Completed in 9 August 2019.
9 August 2019
Quick facts
| Lead sponsor | Samuel Fortin |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 32 |
| Start date | 8 August 2018 |
| Primary completion | 9 August 2019 |
| Estimated completion | 9 August 2019 |
| Sites | 2 locations across Canada |
Drugs / interventions tested
- MAG-EPA/MAG-DHA omega-3 oils
Conditions studied
- Pharmacokinetic in Normal Population — all drugs for Pharmacokinetic in Normal Population →
Sponsor
Samuel Fortin
Who can join
19 and older, any sex, with Pharmacokinetic in Normal Population. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of this study is to establish the pharmacokinetic curve for two different doses of MaxSimil at steady-state over a 20-week period, namely two (2) or three (3) tablets per day. MaxSimil is a concentrated fish oil monoglyceride (MAG) that facilitates absorption of the omega-3 oils by the body. Each capsule contains 300 mg of monoglyceride eicosapentaenoic acid (MAG-EPA) and 130 mg of monoglyceride docosahexaenoic acid (MAG-DHA). Thirty-two (32) subjects will be enrolled and randomly assigned to one of the two parallel treatment doses. Pharmacokinetics will be assessed by measuring the omega-3 index at eight (8) different times during the study. A first sample will be taken before the start of treatment and then every four (4) weeks during treatment. Then, two last measurements of the omega-3 index will be done at four (4) and seven (7) weeks after the end of treatment. Apart from the study treatment and collection of samples for the measurement of the omega-3 index, the only other interventions will be the measurement of body weight at screening and at the end of the study, pregnancy test for women at screening, questioning for demographic information and for the follow-up of the subject's health and concomitant medication intake.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03735836
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Related trials
Other Samuel Fortin trials
Trials by the same sponsor.
- NCT06695910 — Modulation of the Brain Fog Scale by Eicosapentaenoic Acid Monoglycerides (MAG-EPA). · Phase 4 · recruiting
- NCT03915535 — Impact of Fish Oil Monoglycerides on the Modulation of Mitochondrial Functions and Lactate Threshold · Phase 4 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03735836 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Samuel Fortin
- Last refreshed: 20 September 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03735836.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing