Effects of Phyllanthus emblica extract on endothelial dysfunction and biomarkers of oxidative stress in patients with type 2 diabetes mellitus: a randomized, double-blind, controlled study

Abstract

BackgroundIt has been reported that hyperglycemia can induce endothelial dysfunction via increased oxidative stress and that it plays a central role in the development of atherosclerosis and coronary heart disease. Phyllanthus emblica (Emblica officinalis, amla) is known for its antioxidant and antihyperlipidemic activity. The present study compared the effects of an aqueous extract of P. emblica (highly standardized by high-performance liquid chromatography to contain low molecular weight hydrolyzable tannins, ie, emblicanin A, emblicanin B, pedunculagin, and punigluconin) versus those of atorvastatin and placebo on endothelial dysfunction and biomarkers of oxidative stress in patients with type 2 diabetes.MethodsEligible patients were randomized to receive either P. emblica 250 mg twice daily, P. emblica 500 mg twice daily, atorvastatin 10 mg in the evening and matching placebo in the morning, or placebo twice daily for 12 weeks. The primary efficacy parameter was the change in endothelial function identified on salbutamol challenge at baseline and after 12 weeks of treatment. Secondary efficacy parameters were changes in biomarkers of oxidative stress (malondialdehyde, nitric oxide, and glutathione), high sensitivity C-reactive protein levels, the lipid profile, and glycosylated hemoglobin (HbA1c) levels. Laboratory safety parameters were measured at baseline and after 12 weeks of treatment.ResultsEighty patients completed the study. Treatment with P. emblica 250 mg, P. emblica 500 mg, or atorvastatin 10 mg produced significant reductions in the reflection index (−2.25%±1.37% to −9.13%±2.56% versus −2.11%±0.98% to −10.04%±0.92% versus −2.68%±1.13% to −11.03%±3.93%, respectively), suggesting improvement in endothelial function after 12 weeks of treatment compared with baseline. There was a significant improvement in biomarkers of oxidative stress and systemic inflammation compared with baseline and placebo. Further, the treatments significantly improved the lipid profile and HbA1c levels compared with baseline and placebo. All treatments were well tolerated.ConclusionBoth atorvastatin and P. emblica significantly improved endothelial function and reduced biomarkers of oxidative stress and systemic inflammation in patients with type 2 diabetes mellitus, without any significant changes in laboratory safety parameters.

Supplementation of a Standardized Extract fromPhyllanthus emblicaImproves Cardiovascular Risk Factors and Platelet Aggregation in Overweight/Class-1 Obese Adults

“… 24 Another recent study demonstrated a significant decrease of LDL-C and a concomitant increase of HDL-C in 42 subjects with type 2 diabetes supplemented with CAPROS (500 mg, twice daily) for 12 weeks. 12 , 13…”

“… 16 The significant hs-CRP-lowering effect observed in the current study is comparable to earlier studies on CAPROS supplementation. 12 , 13…”

<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>

“…61 Schiano et al 62 and Mackay et al 63 reported no change in hsCRP and platelet aggregation with ω-3FAs. In previous studies 27,64 carried out in our department, we reported the beneficial effects of PCC and its constituent materials on hsCRP. In the present study, we observed a significant change in hsCRP values at 12 weeks in all three treatment groups.…”

“…Clinical studies in humans have proven the hypolipidemic, antioxidant and cardioprotective activities of P. emblica. [27][28][29][30][31][32][33] Shilajit, a rock exudate containing free and chromoprotein-conjugated dibenzo-α-pyrones (urolithins) and fulvic acids as bioactives, finds broad use in Ayurveda for different clinical applications, such as improving cardiovascular health, upregulating collagen and related extracellular matrix protein genes [34][35][36][37][38] Shilajit seems to induce the growth of blood vessels 39 and has a prominent cardioprotective effect. 40 A clinical study with ω-3FA, in combination with another product, to broaden the spectrum of cardiovascular benefits of ω-3FA in T2DM, without increasing the size or cost of the dosage form significantly, is warranted.…”

The relationship between deiodinase activity and inflammatory responses under the stimulation of uremic toxins

“…[31], infection, iron overload [32], and antioxidant deficiency [33], etc. Oxidative stress can provoke inflammation by activating NF-κB and causing the subsequent generation of pro-inflammatory cytokines (Figure 6) [34].…”