Treatment with omega-3 polyunsaturated fatty acids does not improve endothelial function in patients with type 2 diabetes and very high cardiovascular risk: A randomized, double-blind, placebo-controlled study (Omega-FMD)

Siniarski, Aleksander; Haberka, Maciej; Mostowik, Magdalena; Gołębiowska-Wiatrak, Renata; Poręba, Małgorzata; Malinowski, Krzysztof Piotr; Gąsior, Zbigniew; Konduracka, Ewa; Nessler, Jadwiga; Gajos, Grzegorz

doi:10.1016/j.atherosclerosis.2018.02.030

Cited by 31 publications

(27 citation statements)

References 41 publications

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“…To date omega-3 PUFA effects on cardiovascular endpoints remain still unclear and might vary based on different types/doses of dietary omega-3 intakes and the presence of other medications (i.e., statins) in the clinical trials performed so far. Consistently, the recent results of the REDUCE-IT trial, which involved 19212 patients with elevated triglyceride levels at risk for ischemic events, showed that treatment with 4 g/die of EPA, a dose twice and 4-times higher compared to the dose tested in the Omega-FMD study [57] and ASCEND study [58], respectively, resulted in decreased risk of primary and secondary composite cardiovascular end points (i.e., cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina) of 25 and 26%, respectively [60]. Several ongoing large randomized clinical trials (i.e., EVAPORATE [61], VITamin D and OmegA-3 TriaL, VITAL [62], STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia, and STRENGTH (ClinicalTrials.gov Identifier NCT02104817)) will shed more light on the possible associations between omega-3 supplementation and reduction of risk of major cardiovascular events.…”

Section: N-3 Polyunsaturated Fattysupporting

confidence: 55%

“…In contrast, a recent meta-analysis of 10 trials involving 77917 individuals did not provide support for the AHA recommendations in individuals with a history of CHD for the prevention of fatal CHD, nonfatal MI, or any other vascular events [56]. Consistently, in a recent clinical trial, three months of treatment with PUFAs at a dose of 2 g/die did not improve endothelial function in patients with type 2 diabetes and high cardiovascular risk [57]. Similarly, in the ASCEND study, after a follow-up of 7.4 years, patients with diabetes and no evidence of cardiovascular disease, who received a daily supplement of ω-3 fatty acids, did not show a significantly lower incidence of serious vascular events than those who received placebo [58].…”

Section: N-3 Polyunsaturated Fattymentioning

confidence: 91%

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The Use of Nutraceuticals to Counteract Atherosclerosis: The Role of the Notch Pathway

Aquila

Marracino

Martino

et al. 2019

Oxidative Medicine and Cellular Longevity

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Despite the currently available pharmacotherapies, today, thirty percent of worldwide deaths are due to cardiovascular diseases (CVDs), whose primary cause is atherosclerosis, an inflammatory disorder characterized by the buildup of lipid deposits on the inside of arteries. Multiple cellular signaling pathways have been shown to be involved in the processes underlying atherosclerosis, and evidence has been accumulating for the crucial role of Notch receptors in regulating the functions of the diverse cell types involved in atherosclerosis onset and progression. Several classes of nutraceuticals have potential benefits for the prevention and treatment of atherosclerosis and CVDs, some of which could in part be due to their ability to modulate the Notch pathway. In this review, we summarize the current state of knowledge on the role of Notch in vascular health and its modulation by nutraceuticals for the prevention of atherosclerosis and/or treatment of related CVDs.

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Section: N-3 Polyunsaturated Fattysupporting

confidence: 55%

Section: N-3 Polyunsaturated Fattymentioning

confidence: 91%

The Use of Nutraceuticals to Counteract Atherosclerosis: The Role of the Notch Pathway

Aquila

Marracino

Martino

et al. 2019

Oxidative Medicine and Cellular Longevity

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“…In a 12-week study by Wong et al 50 on T2DM patients, no improvement in EnD was seen with ω-3FA (4 g/day). Similarly, Siniarski et al 51 reported no improvement in EnD with 1000mg EPA plus 1000mg DHA taken per day. In a previous study 52 in our department, we showed the beneficial effect of PCC on endothelial function in T2DM patients.…”

Section: Discussionmentioning

confidence: 96%

<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>

Pingali¹,

Nutalapati²,

Illendulla³

2020

DMSO

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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.

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“…However, a study conducted in a Dutch adult population (with no history of MI) found that consumption of EPA plus DHA at low level (40–150 mg/d) did not render protection from non‐fatal MI or CHD . Furthermore, EPA at 226 mg–1.8 g/d had no significant association with non‐fatal MI and any CHD events or did not improve the endothelial functions, metabolic, coagulation and inflammatory status in type 2 diabetes patients with high risk for CVD . Conclusions of various clinical trials that produced a beneficial effect against mortality is given in Table .…”

Section: Effects Of Omega Fatty Acids In Coronary Heart Diseasementioning

confidence: 99%

Omega‐3 fatty acids in coronary heart disease: Recent updates and future perspectives

Ajith

Jayakumar

2018

Clin Exp Pharma Physio

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Incidence of coronary heart disease (CHD) increases worldwide with varying etiological factors. In addition to the control of risk factors, dietary modification has been recommended to reduce the prevalence. Omega-3 (ω-3) fatty acids (FAs), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), of fish oil are beneficial for the prevention of CHD. The effect can be ascribed to anti-inflammatory, vasodilating, antiarrhythmic, antihypertensive activities and lowering of triacyl glycerol level. The American Heart Association advises two fish meals per week in subjects without CHD or supplementation of 1 g of EPA plus DHA per day in subjects with CHD. Despite the beneficial effects of EPA/DHA reported in some of the clinical trials, results of many others were inconsistent that can be ascribed to short duration of studies, low doses of ω-3 FAs, variations in the EPA:DHA ratio, selection of patients with different risk factors or interaction of ω-3 FAs with drugs used in the therapy. Therefore, well designed clinical trials in various populations are warranted. This article discusses the current situation and future prospective of ω-3 FAs in CHD.

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Treatment with omega-3 polyunsaturated fatty acids does not improve endothelial function in patients with type 2 diabetes and very high cardiovascular risk: A randomized, double-blind, placebo-controlled study (Omega-FMD)

Cited by 31 publications

References 41 publications

The Use of Nutraceuticals to Counteract Atherosclerosis: The Role of the Notch Pathway

The Use of Nutraceuticals to Counteract Atherosclerosis: The Role of the Notch Pathway

<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>

Omega‐3 fatty acids in coronary heart disease: Recent updates and future perspectives

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