Trial reportLipids in health and disease2017
A novel self-micro-emulsifying delivery system (SMEDS) formulation significantly improves the fasting absorption of EPA and DHA from a single dose of an omega-3 ethyl ester concentrate.
Trial report in Lipids in health and disease, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 47 citations in OpenAlex.
- Marine-derived n-3 fatty acids therapy for stroke.The Cochrane database of systematic reviews · 2022Pooled it
- Marine-derived n-3 fatty acids therapy for stroke.The Cochrane database of systematic reviews · 2019Pooled it
- Enhanced Production of EPA-Derived Anti-Inflammatory Metabolites after Oral Administration of a Novel Self-Emulsifying Highly Purified EPA Ethyl Ester Formulation (MND-2119).Journal of atherosclerosis and thrombosis · 2023Trial
- Bioequivalence of long-chain omega-3 polyunsaturated fatty acids from foods enriched with a novel vegetable-based omega-3 delivery system compared to gel capsules: a randomized controlled cross-over acute trial.European journal of nutrition · 2022Trial
- A self-emulsifying Omega-3 ethyl ester formulation (AquaCelle) significantly improves eicosapentaenoic and docosahexaenoic acid bioavailability in healthy adults.European journal of nutrition · 2020Trial
- Postprandial variability in plasma long-chain omega-3 is independent of supplement lipid structure.Asia Pacific journal of clinical nutrition · 2025Review
- Novel Micellar Formulation of Silymarin (Milk Thistle) with Enhanced Bioavailability in a Double-Blind, Randomized, Crossover Human Trial.Pharmaceutics · 2025Article
- A Comparison of the Treatment Effects of a Risperidone Solution, an Equal Ratio of DHA/ARA, and a Larger Ratio of Omega-6 PUFA Added to Omega-3 PUFA: An Open-Label Clinical Trial.Current issues in molecular biology · 2025Article
- A randomized double-blind trial to measure the absorption characteristics of eicosapentaenoic acid and docosahexaenoic acid rich oil blend with natural lipid-based delivery system.Food science and biotechnology · 2024Article
- Evaluation of the Metabolite Profile of Fish Oil Omega-3 Fatty Acids (n-3 FAs) in Micellar and Enteric-Coated Forms-A Randomized, Cross-Over Human Study.Metabolites · 2024Article
- Enhancement of yogurt functionality by addingFood science & nutrition · 2024Article
- Review
- Highly Valuable Fish Oil: Formation Process, Enrichment, Subsequent Utilization, and Storage of Eicosapentaenoic Acid Ethyl Esters.Molecules (Basel, Switzerland) · 2023Review
- A self-emulsifying omega-3 fatty acids delivery system for enhanced gastro-intestinal absorption in rats.Food science and biotechnology · 2022Article
- Pharmacokinetics of a Single Intake of a Self-Emulsifying Drug Delivery System Containing the Triglyceride Form of DHA: A Randomized, Double-Blinded, Crossover Study.Current developments in nutrition · 2022Article
- Health Benefits, Food Applications, and Sustainability of Microalgae-Derived N-3 PUFA.Foods (Basel, Switzerland) · 2022Review
- Omega-3 fatty acid supplementation and fecundability.Human reproduction (Oxford, England) · 2022Article
- Formation of Self-Assembled Liquid Crystalline Nanoparticles and Absorption Enhancement of Ω-3s by Phospholipids and Oleic Acids.Pharmaceutics · 2021Article
- Yogurt fortified with omega-3 using nanoemulsion containing flaxseed oil: Investigation of physicochemical properties.Food science & nutrition · 2021Article
- Essential Fatty Acids as Biomedicines in Cardiac Health.Biomedicines · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAbsorption of EPA and DHA from Omega-3-acid ethyl ester (EE) concentrate supplements occurs most efficiently when taken in context of a fatty meal; adequate fat intake is required to release bile salts that emulsify and pancreatic enzymes that digest omega-3-containing lipids in the intestine. Current guidelines recommend reduction in fat intake and therefore there is a need to optimize the absorption of Omega-3 in those consuming low-fat or no-fat meals. To this end, BASF has developed an Absorption Acceleration Technology, a novel self-micro-emulsifying delivery system (SMEDS) formulation of highly concentrated Omega-3-acid EE which enables rapid emulsification and microdroplet formation upon entering the aqueous environment of the gut therefore enhances the absorption.
methodsTwo separate single dose, crossover studies were conducted to determine the relative bioavailability of omega-3-acid EE concentrate, either as a novel SMEDS formulation (PRF-021) or as control, in healthy fasted male and female adults at two dose levels (Study 1 "low dose": 630 mg EPA + DHA in PRF-021 vs. 840 mg EPA + DHA in control; Study 2 "high dose": 1680 mg EPA + DHA in PRF-021 vs. 3360 mg EPA + DHA in control). Blood samples were collected immediately before supplementation and at defined time intervals for 48 h. Plasma concentration of total EPA and DHA were determined for pharmacokinetic analysis, area under the curve (AUC) and maximum observed concentration (C
resultsTotal EPA plus DHA absorption from SMEDS formulation PRF-021 were 6.4 and 11.5 times higher compared to control in low- and high-dose studies respectively, determined as the ratio of baseline corrected, dose normalized AUC
conclusionPRF-021 is a novel SMEDS formulation of Omega-3-acid EE demonstrating a marked improvement in absorption of a single dose of EPA and DHA EE under fasted conditions. This allows adequate absorption of Omega-3 from the supplement without the requirement of a high-fat meal.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.