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BACKGROUND Studies have shown that blue mussel lipid extract (BMLE) has strong anti-inflammatory activity in both rheumatoid arthritis patients and animal arthritis models. Chronic inflammation was closely related to type 2 diabetes mellitus (T2DM). While the beneficial effects cannot be completely attributed to n-3 polyunsaturated fatty acids. The aim of the present study was to investigate whether BMLE can improve glycemic traits of T2DM patients. METHOD In a double-blind randomized controlled trial, 133 Chinese T2DM participants were randomized to either fish oil (FO, n=44), BMLE (n=44) or corn oil group (CO, n=45) for 60 days. The participants were asked to take corresponding oil capsules (2 capsules/day, 0.8g/capsule), which provided 1.6g/day of FO (29.9% eicosapentaenoic acid (EPA)+20.4% docosahexaenoic acid (DHA)), BMLE (20.7% EPA + 26.7% DHA) or CO (53.5% linoleic acid). RESULTS Fasting serum concentration of insulin (P = 0.005) and homeostasis model of insulin resistance (P = 0.026) was significantly decreased in BMLE group, whereas no significant change was found in FO or CO group. There was no significant difference between groups on serum glycosylated hemoglobin. Tumor necrosis factor-α was significantly decreased in BMLE group (P = 0.003), but not in FO or CO group. Significant decrease of interleukin-1β was observed in BMLE and CO groups (P = 0.004 and P = 0.011, respectively), but not in FO group. The total cholesterol was significantly decreased in BMLE and CO groups (P < 0.001 and P < 0.001, respectively), but not in FO group. Triacylglycerol was significantly decreased in BMLE group (P = 0.007), but not in FO or CO group. High density lipoprotein cholesterol was significantly lower in BMLE and CO groups than in FO group (P = 0.003). CONCLUSION Blue mussel lipid supplements improved glycemic traits, inflammatory cytokines and lipids profile in Chinese T2DM patients (Chinese Clinical Trial Registration number: ChiCTR1900025617). This article is protected by copyright. All rights reserved.