Trial reportCardiovascular diabetology2026
Marine n-3 fatty acid treatment for carotid plaques in patients with type 2 diabetes.
Trial report in Cardiovascular diabetology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03708887 (Double-blind and Placebo-controlled Study on Intervention Effect of n-3 Fatty Acids on Glucose and Lipid Homeostasis Disorders in Obese/Diabetic Populations), which is not on this map. Not yet cited in PubMed.
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Double-blind and Placebo-controlled Study on Intervention Effect of n-3 Fatty Acids on Glucose and Lipid Homeostasis Disorders in Obese/Diabetic Populations
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Authors and funding
30 authors.
Funding
Abstract
backgroundCarotid plaques result from a blockage or narrowing of carotid arteries associated with severe atherosclerotic cardiovascular diseases. We aimed to assess the effect of marine n-3 fatty acid supplementation on carotid plaques among patients with diabetes and whether the effect was modified by genetics.
methodsIn this 14 month double-blind, randomized controlled trial, 415 patients with type 2 diabetes (T2D) were randomly assigned to receive high-dose (3.0 g/day) or low-dose (1.5 g/day) marine n-3 fatty acids (fish oil) or placebo (refined olive oil). The primary outcome was the prevalence of carotid plaques. Secondary outcomes included changes in NMR-derived lipoprotein subclasses. Genetic interactions with the supplementation were also explored.
results383 participants (92.3%) completed the 14 month intervention, and 359 patients (86.5%) completed carotid ultrasound exams. Fish oil supplementation did not significantly reduce the carotid plaque prevalence (P trend = 0.111). Compared to the placebo, the odds ratios (95% CIs) of carotid plaque risk were 1.11 (0.56-2.22) and 0.54 (0.26-1.13) for low-dose and high-dose groups, respectively. Fish oil supplementation also showed no significant effect on the incidence of new carotid plaques (P for trend = 0.304) or the regression of existing plaques (P for trend = 0.390). High-dose intervention significantly reduced remnant cholesterol, LDL-1-triglycerides (TG), HDL-4-TG, and HDL-3-TG. In subgroups by genetic risk, the high-dose intervention significantly reduced carotid plaque risk specifically in patients with a low genetic risk for remnant cholesterol, with no significant benefit observed in those with medium or high genetic risk (P for interaction = 0.008; FDR = 0.056).
conclusionIn patients with T2D, 14 month marine n-3 fatty acid supplementation does not reduce carotid plaque risk but improves lipoprotein profile. The anti-atherosclerotic effect appeared significant in patients with a low genetic risk of remnant cholesterol, warranting further investigation into personalized nutritional strategies.
trial registrationClinicaltrials.gov NCT03708887.
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