<p>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</p>

Abstract

This study was conducted to evaluate the effectiveness of fish oil alone and with an adjunct, a proprietary chromium complex (PCC), on cardiovascular parametersendothelial dysfunction, lipid profile, systemic inflammation and glycosylated hemoglobinin 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 (highsensitivity 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.

Synergistic Effects of Natural Product Combinations in Protecting the Endothelium Against Cardiovascular Risk Factors

“…PCC is known to protect cardiovascular function through its insulin regulatory, hypolipidemic and antioxidant activities. 41 A randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the effect of a fish oil-PCC combination in alleviating endothelial dysfunction in participants with type 2 diabetes mellitus. Fifty-three participants were randomly assigned to receive fish oil alone (2.000 mg/day), fish oil (2.000 mg/day) plus PCC (10 mg/day, 200 μg of Cr 3+ ), or fish oil (2.000 mg/day) plus PCC (20 mg/day, 400 μg of Cr 3+ ) over 12 weeks.…”

Marine Oil from C. finmarchicus Enhances Glucose Homeostasis and Liver Insulin Resistance in Obese Prediabetic Individuals

“…LC n-3 FAs are precursors for eicosanoids and pro-resolving mediators called resolvins, protectins, and maresins, which are known to control and combat chronic inflammation [39]. In recent RCTs, antiinflammatory effects were found with pure EPA + DHA or high-dose (usually enriched) fish oil interventions (e.g., >2 g fish oil per day, containing 600 mg EPA; 400 mg DHA) [40][41][42]. Regarding low doses in CO, another possible mechanism of action is plausible, as follows: in contrast to fish oil TG-bound LC n-3 FAs, wax esters-derived LC n-3 FAs from CO reach the distal intestine, allowing interactions with abundant G-Protein coupled Receptors (GPR120) in intestinal cells [43].…”

Vidangadi Lauha’ for Obese Type 2 Diabetes mellitus; Randomised controlled clinical study

“…Given that the status of these micronutrients in patients with T2DM is already likely to be suboptimal and that these de ciencies are variously associated with diabetic complications such as compromised endothelial, microvascular, vascular and neurological function [10] , Some herbs used in the formulation Vidangadi Lauha formulation have alpha glucosidase inhibitory activity [11] , antidiabetic [12,13] , anti-dyslipidaemia [13,14], hypoglycaemic [15] , and beta cell protective activity [16] . Prevention of platelet aggregation and thrombus formation [17] inhibited the activities of αamylase, α-glucosidase, dipeptidyl peptidase-4 [18] , antiobesity [19] , endothelial dysfunction, oxidative stress, and systemic in ammation [20] . Thus, 'Vidangadi Lauha' can be a very good formulation for the prevention of multiple complications of type 2 diabetes.…”