scholarly journals Effect of Omega-3 Fatty Acid Alone and in Combination with Proprietary Chromium Complex on Endothelial Function in Subjects with Metabolic Syndrome: A Randomized, Double-Blind, Parallel-Group Clinical Study

2021 ◽  
Vol 2021 ◽  
pp. 1-12
Author(s):  
Usharani Pingali ◽  
Chandrasekhar Nutalapati ◽  
Srinivas Gundagani
Keyword(s):  
Oxidative Stress ◽  
Metabolic Syndrome ◽  
Endothelial Function ◽  
Lipid Profile ◽  
Omega 3 ◽  
Double Blind ◽  
Parallel Group ◽  
Group A ◽  
Group B ◽  
Biomarkers Of Oxidative Stress

Metabolic syndrome (MetS) represents a cluster of metabolic abnormalities that include hypertension, central obesity, insulin resistance, and dyslipidemia and is strongly associated with an increased risk of diabetes, cardiovascular diseases (CVD), and all-cause mortality. Early diagnosis is important to employ lifestyle and risk factor modification. Existing therapies are limited. Studies report positive effect of omega-3 fatty acids (ω-3FA) on symptoms of metabolic syndrome. The present study was undertaken to evaluate the effect of ω-3FA alone and in combination with proprietary chromium complex (PCC) on endothelial function in subjects with metabolic syndrome. In this randomized, double-blind, parallel-group study, subjects were enrolled into the study after ethics committee (EC) approval and informed consent. Eligible subjects were randomized to receive ω-3FA concentrate 2000 mg (Group A-18 subjects), ω-3FA concentrate 2000 mg + PCC200 mcg (Group B-19 subjects), and ω-3FA concentrate 2000 mg + PCC400 mcg (Group C-21 subjects) daily for 12 weeks. Endothelial dysfunction as measured by reflection index (RI), biomarkers of oxidative stress (NO, MDA, and glutathione), and inflammation (hsCRP, endothelin-1, ICAM-1, and VCAM-1) were evaluated at baseline, 4, and 12 weeks. Lipid-profile and platelet-aggregation tests were performed at baseline and 12 weeks. Adverse drug reactions were recorded. Compliance was assessed by pill count method. GraphPad Prism8 was used for statistical analysis. Significant changes were seen from 4 weeks onwards in all the parameters evaluated. Significant improvement in RI% (mean ± SD = −2.56 ± 0.77 to −3.27 ± 0.67-group A, −2.33 ± 0.76 to 4.72 ± 0.79-group B; −2.39 ± 1.13 to 6.46 ± 1.00-group C) was seen at 12 weeks. Significant improvement in biomarkers of oxidative stress and inflammation was seen with all the treatment groups. Similarly, significant improvement in lipid profile was seen in group B and group C, while group A showed change in HDL, VLDL, and TG. Group C demonstrated the best response in the parameters evaluated. Three patients in group C reported gastrointestinal adverse events, which resolved spontaneously; none stopped the therapy. So, the addition of PCC to ω-3FA may prove to have beneficial effect in reducing cardiovascular morbidity in MetS patients.

scholarly journals Decrease of Atherosclerosis Markers and Oxidative Stress After 1 Year Administration of Omega-3 Fatty Acids Supplements in Patients with Metabolic Syndrome

2014 ◽  
Vol 21 (3) ◽  
pp. 175-183
Author(s):  
Andreea Dragomir ◽  
Emila Rusu ◽  
Mihaela Posea ◽  
Gabriela Radulian
Keyword(s):  
Oxidative Stress ◽  
Metabolic Syndrome ◽  
Fatty Acids ◽  
Omega 3 Fatty Acids ◽  
Omega 3 ◽  
Atherosclerosis Progression ◽  
Group A ◽  
Group B ◽  
The Impact ◽  
And Oxidative Stress

AbstractBackground and Aims: To assess the impact of 1 year administration of omega-3 fatty acids supplements on oxidative stress parameters and atherosclerosis progression. Material and Methods: A total of 284 patients with metabolic syndrome, aged 61±6.7 years, without clinical evidence of atherosclerosis were allocated to 2 groups, matched by sex and age: group A (140 patients) - diet according to ESC/EASD recommendations; group B (144 patients) - the same diet + capsules of fish oil (1g eicosapentanoic acid, 1g docosahexanoic acid, 0,1g a-tocopherol acetate). Body fat (BF) was measured by bioimpedance analysis. For oxidative stress evaluation we used the FormOx systems monitor on a blood drop and for progression of atherosclerosis the intima-media thickness (IMT) at common carotid artery. Patients were evaluated at baseline, after 6 months and 1 year. Results: IMT significantly decreased in group B vs group A at 1 year (p<0.0001) and was correlated with %BF (p<0.001), waist-to-hip ratio (WHR) (p=0.002), leptin (p< 0.001), adiponectin (p<0.05), leptin/adiponectin ratio (p< 0.001) and oxidative stress (p<0.001). Conclusions: One year administrations of omega-3 PUFA enriched diet reduces cardiovascular risk of metabolic syndrome patients, resulting in a significant decrease of oxidative stress and atherosclerosis progression.

scholarly journals Inhaled Tobramycin in Children with Acute Bacterial Rhinopharyngitis

2006 ◽  
Vol 19 (1) ◽  
pp. 205873920601900 ◽  
Author(s):  
A. Varricchio ◽  
D. Tricarico ◽  
A. DE Lucia ◽  
R. Utili ◽  
M.-F. Tripodi ◽  
...  
Keyword(s):  
Nasal Obstruction ◽  
Resistant Bacteria ◽  
Double Blind ◽  
Oral Amoxicillin ◽  
Parallel Group ◽  
Blind Children ◽  
Amoxicillin Clavulanate ◽  
Group A ◽  
Adenoidal Hypertrophy ◽  
Group B

Antibiotic abuse for treating rhinopharyngitis induces the occurrence of resistant bacteria. As topical drugs might reduce this phenomenon, the aims of our study were to evaluate inhaled tobramycin in children with acute bacterial rhinopharyngitis and to compare it with oral amoxicillin/clavulanate. The trial was conducted as randomized, parallel group and double blind. Children, aged 3–6 years, with acute bacterial rhinopharyngitis were treated with 15 mg of aerosolized tobramycin (Group A) or 50 mg/Kg of amoxicillin/clavulanate (Group B) twice daily for 10 days. The following parameters were assessed: nasal obstruction, mucopurulent rhinorrhea, post-nasal drip, adenoidal hypertrophy, tympanic inflammation, tympanogramm, rhinomanometry and cultures. Of 416 patients screened, 311 children (178 females and 133 males), median age 4.5 years, completed the study: 156 in Group A and 155 in Group B. Both treatments improved all parameters (p<0.01 for all). Intergroup analysis showed that inhaled tobramycin induced a better improvement versus amoxicillin/clavulanate concerning nasal obstruction (p<0.05), adenoidal hypertrophy (p<0.01), tympanic inflammation (p<0.01), rhinomanometry (p<0.01) and cultures (p<0.05). In conclusion, inhaled tobramycin may represent a valid treatment for acute bacterial rhinopharyngitis in children, as it is effective, safe, economic and simple to use.

scholarly journals Effect of Keishibukuryogan on Endothelial Function in Patients with at Least One Component of the Diagnostic Criteria for Metabolic Syndrome: A Controlled Clinical Trial with Crossover Design

2012 ◽  
Vol 2012 ◽  
pp. 1-10 ◽  
Author(s):  
Yutaka Nagata ◽  
Hirozo Goto ◽  
Hiroaki Hikiami ◽  
Tatsuya Nogami ◽  
Makoto Fujimoto ◽  
...  
Keyword(s):  
Metabolic Syndrome ◽  
Clinical Trial ◽  
Endothelial Function ◽  
Reactive Hyperemia ◽  
Control Period ◽  
Crossover Design ◽  
Controlled Clinical Trial ◽  
Related Factors ◽  
Group A ◽  
Group B

We evaluated the effect of keishibukuryogan (KBG; Guizhi-Fuling-Wan), a traditional Japanese (Kampo) formula, on endothelial function assessed by reactive hyperemia peripheral arterial tonometry (Endo-PAT2000) in patients with metabolic syndrome-related factors by controlled clinical trial with crossover design. Ninety-two patients were assigned to group A (first KBG-treatment period, then control period; each lasting 4 weeks, with about one-year interval) or group B (first control, then KBG-treatment). In forty-nine (27, group A; 22, group B) patients completing all tests, the mean value of the natural logarithmic-scaled reactive hyperemia index (L_RHI) increased and those of serum nonesterified fatty acid (NEFA), malondialdehyde, and soluble vascular cell adhesion molecule 1 decreased significantly during the KBG-treatment period, but not during the control period, and 4-week changes of L_RHI, NEFA, and malondialdehyde between the 2 periods showed significance. These results suggest that KBG has beneficial effect on endothelial function in patients with metabolic syndrome-related factors.

scholarly journals The Effects of Vitamin E and Omega-3 PUFAs on Endothelial Function among Adolescents with Metabolic Syndrome

2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Alireza Ahmadi ◽  
Mojgan Gharipour ◽  
Gholamreza Arabzadeh ◽  
Payam Moin ◽  
Mahin Hashemipour ◽  
...  
Keyword(s):  
Metabolic Syndrome ◽  
Vitamin E ◽  
Endothelial Function ◽  
Controlled Trial ◽  
Elisa Test ◽  
Omega 3 ◽  
Double Blind ◽  
Atherosclerosis Progression ◽  
Major Index ◽  
Endothelial Growth Factor

Aim. The present study aims to explore the effects of vitamin E and omega-3 on endothelial function indicators among adolescents with metabolic syndrome.Method. In a randomized, double blind, and placebo-controlled trial, 90 young individuals, aged 10 to 18 years, with metabolic syndrome were randomly assigned to receive either vitamin E tablets (400 IU/day) or omega-3 tablets (2.4 gr/day) or placebo. For assessing endothelial functional state, the serum level of vascular endothelial growth factor (VEGF) was measured by ELISA test.Results. The use of omega-3 supplementation for eight weeks led to significant increase in serum HDL level compared with the group treated with vitamin E or placebo group. In this regard, no significant correlations were found between the change in VEGF and baseline levels of other markers including anthropometric indices and serum lipids. Omega-3 could significantly reduce VEGF with the presence of other baseline variables (Beta=-12.55;P=0.012).Conclusion. The administration of omega-3 can effectively improve endothelial function in adolescents with metabolic syndrome by reducing the level of serum VEGF, as a major index for atherosclerosis progression and endothelial destabilization. Omega-3 can be proposed as a VEGF antagonist for improving endothelial function in metabolic syndrome. The clinical implications of our findings should be assessed in future studies.

scholarly journals Comparison of the treatment mediated changes in serum lipid profile of cases with metabolic syndrome treated with low dose atorvastatin versus the usual care group

2017 ◽  
Vol 6 (3) ◽  
pp. 624
Author(s):  
Shubhangam Sharma ◽  
Hemlata Verma ◽  
Anuradha Dubey
Keyword(s):  
Metabolic Syndrome ◽  
Usual Care ◽  
Lipid Profile ◽  
Serum Lipid ◽  
Low Dose ◽  
Tertiary Care ◽  
Cardiovascular Outcomes ◽  
Serum Lipid Profile ◽  
Group A ◽  
Group B

Background: Metabolic syndrome (MetS) is a constellation of cardiometabolic risk determinants comprising of obesity, insulin resistance, dyslipidaemia and hypertension. In view of the epidemic of metabolic syndrome, this prospective, comparative study done in OPD setting in a tertiary care centre of central India aimed at finding out the changes in lipid profile, a surrogate marker of cardiovascular morbidities on treatment with low dose atorvastatin versus the usual care group.Methods: Patients satisfying NCEP-ATPIII criteria for metabolic syndrome were divided into two groups. Group A received treatment with 20 mg Atorvastatin along with target driven treatment for hypertension and elevated glucose, as required. Group B received the same except for atorvastatin. Serum lipid profiles were recorded and changes were compared before and after study duration of 3 months. Also, cardiac events were kept track of during follow up.Results: At the end of study it was found that treatment mediated changes in the lipid profile were highly significant (p<0.001) and favourable in group A as compared to Group B. Also, lesser cardiovascular outcomes were observed in Group A patients.Conclusions: The study concludes that among patients with metabolic syndrome, those treated with statins benefitted more than those who did not take statin therapy. This benefit in the correction of serum lipid profile also translated in terms of decreased cardiovascular outcomes in Group A patients. Hence, low dose atorvastatin therapy provides a potential approach for treatment of patients with metabolic syndrome.

scholarly journals Comparative study of magnesium, sodium valproate, and concurrent magnesium-sodium valproate therapy in the prevention of migraine headaches: a randomized controlled double-blind trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Samira Khani ◽  
Seyed Amir Hejazi ◽  
Mehdi Yaghoubi ◽  
Ehsan Sharifipour
Keyword(s):  
Sodium Valproate ◽  
Migraine Prophylaxis ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
The Third ◽  
Migraine Headaches ◽  
Parallel Group ◽  
Significant Difference ◽  
Group A ◽  
Group B

Abstract Objective This study aimed to assess the efficacy of concurrent magnesium-sodium valproate therapy and compare it with either magnesium or sodium valproate alone in migraine prophylaxis. Materials and methods This randomized single-center double-blind parallel-group controlled clinical trial study was conducted on migraine patients within the age range of 18–65 years. The subjects with at least four monthly attacks were randomly assigned to group A (n = 82) sodium valproate, group B (n = 70) magnesium with sodium valproate, and group C (n = 70) magnesium. The patients passed a one-month baseline without prophylactic therapy and then received a 3-month treatment. The characteristics of migraine, including frequency, severity, duration of the attacks, and the number of painkillers taken per month, were monthly recorded in each visit. The Migraine Disability Assessment (MIDAS) and Headache Impact Test-6 (HIT-6) scores were recorded at the baseline and after 3 months of treatment in each group. Within- and between-group analyses were performed in this study. Results The obtained results revealed a significant reduction in all migraine characteristics in all groups compared to those reported for the baseline (P <  0.001). Intragroup data analysis indicated that there was no statistically significant difference in headache frequency between groups A and B in the third month (P = 0.525); nevertheless, three other parameters showed a significant reduction in group B, compared to those reported for group A in the third month (P <  0.05). On the other hand, group C could not effectively reduce measured parameters in the patients, compared to groups A and B after 3 months (P <  0.001). Furthermore, the MIDAS and HIT-6 scores significantly diminished in groups A, B, and C compared to those reported at the baseline (P <  0.001), and these changes were more significant in groups A and B than in group C (P <  0.001). Conclusion The obtained results of this study revealed that magnesium could enhance the antimigraine properties of sodium valproate in combination therapy and reduce the required valproate dose for migraine prophylaxis.

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