Diabetes, Metabolic Syndrome and Obesity (Jan 2020)
Evaluation of the Effect of Fish Oil Alone and in Combination with a Proprietary Chromium Complex on Endothelial Dysfunction, Systemic Inflammation and Lipid Profile in Type 2 Diabetes Mellitus – A Randomized, Double-Blind, Placebo-Controlled Clinical Study
Abstract
Usharani Pingali, 1 Chandrasekhar Nutalapati, 1 Vijay Sravanthi Illendulla 2 1Department of Clinical Pharmacology & Therapeutics, Nizam’s Institute of Medical Sciences, Hyderabad, Telangana, 500082, India; 2Govt. Ayurvedic Dispensary, Primary Health Center Gummadidala, Sangareddy, Telangana, 502313, IndiaCorrespondence: Usharani PingaliDepartment of Clinical Pharmacology & Therapeutics, Nizam’s Institute of Medical Sciences, Hyderabad 500082, Telangana, IndiaTel +91 9849574143Email [email protected]: This study was conducted to evaluate the effectiveness of fish oil alone and with an adjunct, a proprietary chromium complex (PCC), on cardiovascular parameters – endothelial dysfunction, lipid profile, systemic inflammation and glycosylated hemoglobin – in a 12-week randomized, double-blind, placebo-controlled clinical study in type 2 diabetes mellitus subjects.Patients and Methods: In this randomized, double-blind, parallel group study, 59 subjects in three groups completed the study: Group A, fish oil 2000 mg; Group B, fish oil 2000 mg + PCC 10 mg (200 μg of Cr 3+); and Group C, fish oil 2000 mg + PCC 20 mg (400 μg of Cr 3+) daily for 12 weeks (2000 mg of fish oil contained 600 mg of eicosapentaenoic acid [EPA] and 400 mg of docosahexaenoic acid [DHA], the omega-3 fatty acids). Endothelial function, by estimating reflection index (RI), biomarkers of oxidative stress (nitric oxide [NO], malondialdehyde [MDA], glutathione [GSH]) and inflammatory biomarkers (high-sensitivity C-reactive protein [hsCRP], intercellular adhesion molecule-1 [ICAM-1], vascular cell adhesion molecule-1 [VCAM-1], endothelin-1) were evaluated at baseline, and 4 and 12 weeks. Lipid profile, platelet aggregation and glycosylated hemoglobin [HbA1c) were tested at baseline and 12 weeks. Any reported adverse drug reactions were recorded. Statistical analysis was performed using GraphPad Prism 8.Results: The present study shows that fish oil by itself, at a dose of 2000 mg (600 mg of EPA + 400 mg of DHA) per day, led to significant, but only modest, improvement in cardiovascular parameters (RI from − 2.38± 0.75 to − 3.92± 0.60, MDA from 3.77± 0.16 to 3.74± 0.16 nM/mL, NO from 30.60± 3.18 to 32.12± 3.40 μM/L, GSH from 568.93± 5.91 to 583.95± 6.53 μM/L; p≤ 0.0001), including triglyceride levels. However, when PCC was added to fish oil, especially at the 20 mg dose, there were highly significant improvements in all the parameters tested (RI from − 2.04± 0.79 to − 8.73± 1.36, MDA from 3.67± 0.39 to 2.89± 0.34 nM/mL, NO from 28.98± 2.93 to 40.01± 2.53 μM/L, GSH from 553.82± 8.18 to 677.99± 10.19 μM/L; p≤ 0.0001), including the lipid profile. It is noteworthy that the triglycerides were decreased significantly by addition of 20 mg of PCC although the dose of fish oil was only 2 g/day and the baseline triglyceride levels were only about 200 mg/dL. Fish oil alone did not significantly decrease the HbA1c, whereas the addition of 20 mg of PCC did.Conclusion: Addition of PCC, especially at 20 mg dose, significantly improves the efficacy of fish oil in addressing cardiovascular risk factors compared to fish oil given alone.Keywords: fish oil, Crominex®, diabetes mellitus, omega-3 fatty acids, trivalent chromium, Cr3+
