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      Hypolipidemic Effect of Arthrospira ( Spirulina) maxima Supplementation and a Systematic Physical Exercise Program in Overweight and Obese Men: A Double-Blind, Randomized, and Crossover Controlled Trial

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          Abstract

          Low-fat diets, lipid-modifying nutraceuticals and a higher level of physical activity are often recommended to reduce dyslipidemia. A double-blind, randomized, crossover, controlled trial was designed to evaluate the independent and synergistic effects of Arthrospira ( Spirulina) maxima supplementation (4.5 g·day −1) with or without performing a physical exercise program ( PEP: aerobic exercise (3 days·week −1) + high-intensity interval training (2 days·week −1)) on blood lipids and BMI of 52 sedentary men with excess body weight. During six weeks, all participants were assigned to four intervention treatments ( Spirulina maxima with PEP (SE), placebo with PEP (Ex), Spirulina maxima without PEP (Sm), placebo without PEP (C; control)) and plasma lipids were evaluated spectrophotometrically pre- vs. post intervention in stratified subgroups (overweight, obese and dyslipidemic subjects). Pre/post comparisons showed significant reductions in all plasma lipids in the SE group, particularly in those with dyslipidemia ( p ≤ 0.043). Comparing the final vs. the initial values, BMI, total cholesterol, triglycerides and low-density lipoprotein cholesterol were decreased. High-density lipoprotein cholesterol increased in all treatment groups compared to C. Changes were observed mostly in SE interventions, particularly in dyslipidemic subjects ( p < 0.05). Spirulina maxima supplementation enhances the hypolipidemic effect of a systematic PEP in men with excess body weight and dyslipidemia.

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          Most cited references36

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          Statin-associated myopathy.

          Statins (3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors) are associated with skeletal muscle complaints, including clinically important myositis and rhabdomyolysis, mild serum creatine kinase (CK) elevations, myalgia with and without elevated CK levels, muscle weakness, muscle cramps, and persistent myalgia and CK elevations after statin withdrawal. We performed a literature review to provide a clinical summary of statin-associated myopathy and discuss possible mediating mechanisms. We also update the US Food and Drug Administration (FDA) reports on statin-associated rhabdomyolysis. Articles on statin myopathy were identified via a PubMed search through November 2002 and articles on statin clinical trials, case series, and review articles were identified via a PubMed search through January 2003. Adverse event reports of statin-associated rhabdomyolysis were also collected from the FDA MEDWATCH database. The literature review found that reports of muscle problems during statin clinical trials are extremely rare. The FDA MEDWATCH Reporting System lists 3339 cases of statin-associated rhabdomyolysis reported between January 1, 1990, and March 31, 2002. Cerivastatin was the most commonly implicated statin. Few data are available regarding the frequency of less-serious events such as muscle pain and weakness, which may affect 1% to 5% of patients. The risk of rhabdomyolysis and other adverse effects with statin use can be exacerbated by several factors, including compromised hepatic and renal function, hypothyroidism, diabetes, and concomitant medications. Medications such as the fibrate gemfibrozil alter statin metabolism and increase statin plasma concentration. How statins injure skeletal muscle is not clear, although recent evidence suggests that statins reduce the production of small regulatory proteins that are important for myocyte maintenance.
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            Generation of allocation sequences in randomised trials: chance, not choice.

            The randomised controlled trial sets the gold standard of clinical research. However, randomisation persists as perhaps the least-understood aspect of a trial. Moreover, anything short of proper randomisation courts selection and confounding biases. Researchers should spurn all systematic, non-random methods of allocation. Trial participants should be assigned to comparison groups based on a random process. Simple (unrestricted) randomisation, analogous to repeated fair coin-tossing, is the most basic of sequence generation approaches. Furthermore, no other approach, irrespective of its complexity and sophistication, surpasses simple randomisation for prevention of bias. Investigators should, therefore, use this method more often than they do, and readers should expect and accept disparities in group sizes. Several other complicated restricted randomisation procedures limit the likelihood of undesirable sample size imbalances in the intervention groups. The most frequently used restricted sequence generation procedure is blocked randomisation. If this method is used, investigators should randomly vary the block sizes and use larger block sizes, particularly in an unblinded trial. Other restricted procedures, such as urn randomisation, combine beneficial attributes of simple and restricted randomisation by preserving most of the unpredictability while achieving some balance. The effectiveness of stratified randomisation depends on use of a restricted randomisation approach to balance the allocation sequences for each stratum. Generation of a proper randomisation sequence takes little time and effort but affords big rewards in scientific accuracy and credibility. Investigators should devote appropriate resources to the generation of properly randomised trials and reporting their methods clearly.
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              Exercise for overweight or obesity

              Clinical trials have shown that exercise in adults with overweight or obesity can reduce bodyweight. There has been no quantitative systematic review of this in The Cochrane Library. To assess exercise as a means of achieving weight loss in people with overweight or obesity, using randomised controlled clinical trials. Studies were obtained from computerised searches of multiple electronic bibliographic databases. The last search was conducted in January 2006. Studies were included if they were randomised controlled trials that examined body weight change using one or more physical activity intervention in adults with overweight or obesity at baseline and loss to follow-up of participants of less than 15%. Two authors independently assessed trial quality and extracted data. The 43 studies included 3476 participants. Although significant heterogeneity in some of the main effects' analyses limited ability to pool effect sizes across some studies, a number of pooled effect sizes were calculated. When compared with no treatment, exercise resulted in small weight losses across studies. Exercise combined with diet resulted in a greater weight reduction than diet alone (WMD -1.1 kg; 95% confidence interval (CI) -1.5 to -0.6). Increasing exercise intensity increased the magnitude of weight loss (WMD -1.5 kg; 95% CI -2.3 to -0.7). There were significant differences in other outcome measures such as serum lipids, blood pressure and fasting plasma glucose. Exercise as a sole weight loss intervention resulted in significant reductions in diastolic blood pressure (WMD -2 mmHg; 95% CI -4 to -1), triglycerides (WMD -0.2 mmol/L; 95% CI -0.3 to -0.1) and fasting glucose (WMD -0.2 mmol/L; 95% CI -0.3 to -0.1). Higher intensity exercise resulted in greater reduction in fasting serum glucose than lower intensity exercise (WMD -0.3 mmol/L; 95% CI -0.5 to -0.2). No data were identified on adverse events, quality of life, morbidity, costs or on mortality. The results of this review support the use of exercise as a weight loss intervention, particularly when combined with dietary change. Exercise is associated with improved cardiovascular disease risk factors even if no weight is lost.
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                Author and article information

                Journal
                Mar Drugs
                Mar Drugs
                marinedrugs
                Marine Drugs
                MDPI
                1660-3397
                07 May 2019
                May 2019
                : 17
                : 5
                : 270
                Affiliations
                [1 ]Medicine and Psychology School, Autonomous University of Baja California, Tijuana 22390, Mexico; marco.antonio.hernandez.lepe@ 123456uabc.edu.mx
                [2 ]Biomedical Sciences Institute. Autonomous University of Ciudad Juarez, Ciudad Juarez 32310, Mexico; awall@ 123456uacj.mx (A.W.-M.); joslopez@ 123456uacj.mx (J.A.L.-D.)
                [3 ]Medicine School, National Autonomous University of Mexico, Mexico City 04510, Mexico; majo_ya@ 123456yahoo.com.mx (M.A.J.-O.); luqueno@ 123456bq.unam.mx (O.I.L.-B)
                [4 ]Physical Culture Sciences School, Autonomous University of Chihuahua, Chihuahua 32310, Mexico; rphernant@ 123456yahoo.com
                Author notes
                [* ]Correspondence: aramos@ 123456uacj.mx ; Tel.: +52-656-1679309
                Author information
                https://orcid.org/0000-0003-1954-2857
                https://orcid.org/0000-0002-6196-3607
                https://orcid.org/0000-0002-4059-665X
                https://orcid.org/0000-0003-1772-5836
                https://orcid.org/0000-0002-4347-6725
                Article
                marinedrugs-17-00270
                10.3390/md17050270
                6562443
                31067674
                54206759-e688-4a61-b23d-d6fcfdd69e13
                © 2019 by the authors.

                Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( http://creativecommons.org/licenses/by/4.0/).

                History
                : 17 April 2019
                : 30 April 2019
                Categories
                Article

                Pharmacology & Pharmaceutical medicine
                arthrospira maxima,dyslipidemia,physical exercise,obesity,double-blind,randomized controlled trial

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