Antihyperlipemic and antihypertensive effects of Spirulina maxima in an open sample of mexican population: a preliminary report

<p>Abstract</p> <p>Background</p> <p><it>Spirulina maxima </it>is a filamentous cyanobacterium used as food supplement because of its high nutrient contents. It has been experimentally proven, <it>in vivo </it>and <it>in vitro </it>that posses several pharmacological properties. The purpose of this study was to evaluate the effects of <it>Spirulina maxima </it>orally supplied (4.5 g/day, for 6 weeks) to a sample of 36 subjects (16 men and 20 women, with ages between 18–65 years) on serum lipids, glucose, aminotransferases and on blood pressure. The volunteers did not modify their dietary habits or lifestyle during the whole experimental period. From each subject, a sample of blood was drawn in fasting state of 12 hours to determi the plasma concentrations of glucose, triacylglycerols (TAG), total cholesterol (TC), cholesterol associated to high density lipoprotein (HDL-C) and aspartate aminotransferase (AST). Anthropometric measurements including systolic (SYST-P) and diastolic (DIAST-P) blood pressure, height, weight and Body Mass Index (BMI) were also recorded.</p> <p>Results</p> <p>Comparing initial and final data, the results showed that there were no significant changes in the values of glucose and AST, but significant differences in TAG, TC, and HDL-C, were observed: TAG 233.7 ± 177.8 vs. 167.7 ± 100.7 mg/dL (p < 0.001), TC 181.7 ± 37.5 vs. 163.5 ± 34.4 mg/dL (p < 0.001), C-HDL 43.5 ± 14.4 vs. 50 ± 18.8 mg/dL (p < 0.01). The univariated analysis showed that the changes in the HDL-C and TC concentrations were dependent on TAG concentration (p = 0.247 and p = 0.108, respectively); nevertheless the calculated values for cholesterol associated to low density lipoprotein (LDL-C) were significantly reduced by the <it>Spirulina maxima </it>treatment but independently of the TAG changes. In addition, significant differences were found comparing initial and final SYST-P and DIAST-P blood pressure in both male and female: SYST-P male 121 ± 9 vs. 111 ± 8 mm Hg (p < 0.01), DIAST-P male 85 ± 6.5 vs. 77 ± 9 mm Hg (p < 0.01); SYST-P female 120 ± 9.5 vs. 109 ± 11 mm Hg (p < 0.002), DIAST-P female 85 ± 11 vs. 79 ± 7.5 mm Hg (p < 0.03).</p> <p>Conclusion</p> <p>The <it>Spirulina maxima </it>showed a hypolipemic effect, especially on the TAG and the LDL-C concentrations but indirectly on TC and HDL-C values. It also reduces systolic and diastolic blood pressure.</p

Hepatoprotective effects of Spirulina maxima in patients with non-alcoholic fatty liver disease: a case series

<p>Abstract</p> <p>Introduction</p> <p>Non-alcoholic fatty liver diseases range from simple steatosis to non-alcoholic steatohepatitis. The "two hits" hypothesis is widely accepted for its pathogenesis: the first hit is an increased fat flux to the liver, which predisposes our patient to a second hit where increasing free fatty acid oxidation into the mitochondria leads to oxidative stress, lipoperoxidation and a chain reaction with increased ROS. Clinical indications include abdominal cramps, meteorism and fatigue. Most patients, however, are asymptomatic, and diagnosis is based on aminotransferase elevation and ultrasonography (or "brilliant liver"). Spirulina maxima has been experimentally proven to possess <it>in vivo </it>and <it>in vitro </it>hepatoprotective properties by maintaining the liver lipid profile. This case report evaluates the hepatoprotective effects of orally supplied Spirulina maxima.</p> <p>Case presentation</p> <p>Three Hispanic Mexican patients (a 43-year-old man, a 77-year-old man and a 44-year-old woman) underwent ultrasonography and were treated with 4.5 g/day of Spirulina maxima for three months. Their blood samples before and after the treatment determined triacylglycerols, total cholesterol, high-density lipoprotein cholesterol, alanine aminotransferase and low-density lipoprotein cholesterol levels. The results were assessed using ultrasound.</p> <p>Conclusion</p> <p>Treatment had therapeutic effects as evidenced by ultrasonography and the aminotransferase data. Hypolipidemic effects were also shown. We conclude that Spirulina maxima may be considered an alternative treatment for patients with non-alcoholic fatty liver diseases and dyslipidemic disorder.</p

The effect of Spirulina sauce, as a functional food, on cardiometabolic risk factors, oxidative stress biomarkers, glycemic profile, and liver enzymes in nonalcoholic fatty liver disease patients:A randomized double-blinded clinical trial

OBJECTIVE: This study sought to investigate the effect of Spirulina on cardiometabolic risk factors, oxidative stress biomarkers, glycemic profile, and liver enzymes in nonalcoholic fatty liver disease (NAFLD) patients. METHODS: This randomized, double‐blind clinical trial was performed on 46 NAFLD patients. Subjects were allocated to consume either Spirulina sauce or placebo, each 20 g/day for 8 weeks. Fatty liver grade, liver enzymes, anthropometric parameters, blood pressure, and serum lipids, glucose, insulin, malondialdehyde, and antioxidant capacity were assessed pre‐ and postintervention. RESULTS: Fatty liver grade was significantly different between the two groups. A significant change for ALT (alanine aminotransferase) and AST (aspartate aminotransferase) was seen between the two groups (p = .03 and .02, respectively), while ALP (alkaline phosphatase) serum levels were not significantly different within or between groups. Pertaining to glycemic profile, all variables, except HOMA‐IR, were not significantly different within or between groups. Finally, statistically significant changes were seen in both MDA (malondialdehyde) and TAC (total antioxidant capacity) among the groups (p = .04 and <.001, respectively). CONCLUSIONS: Spirulina may improve fatty liver grade by modifying liver enzymes, oxidative stress, and some lipid profiles; however, there was effect of Spirulina on anthropometric characteristics and blood pressure

Breakfast habits and differences regarding abdominal obesity in a cross-sectional study in Spanish adults: The ANIBES study

Background: Previous studies have indicated that breakfast has a protective effect against obesity. The aim of this study was to describe the breakfast habits of the Spanish adult population and to assess the possible association between breakfast frequency and the presence of abdominal obesity, in a cross-sectional analysis of the ANIBES Study. Methods: A representative sample of 1655 Spanish adults (aged 39±12 y; (mean±sd)) from the ANIBES Study was investigated. The final field work was carried out from mid-September to November (three months) 2013. Collected data included a dietary data collected by a 3-days food record, and health, socioeconomic, physical activity and anthropometric (weight, height and waist circumference) data. Abdominal obesity was defined as having a waist-to-height ratio ≥0.5. The adults were also classified into three groups based on the number of days they ate breakfast (never (0/3 days), sometimes (1-2/3 days) and always (3/3 days)). Logistic regression analyses were used to evaluate the association between breakfast and abdominal obesity. Results: In total, 3.6% of adults skipped breakfast and 14.1% ate breakfast sometimes. Having always breakfast was negatively associated with abdominal obesity [OR = 0.738 (0.558–0.975) p = 0.033]. The odds of abdominal obesity after full adjustment (age, gender, and educational and activity level) were 1.5 times higher for those who skipped breakfast when compared to those who always have breakfast. By correcting the model considered for other variables, the odds among smokers decreased when they have breakfast sometimes [OR = 0.032 (0.003–0.387) p = 0.007] and always [OR = 0.023 (0.002–0.270) p = 0.003] comparing with smokers who skip breakfast. Conclusion: Breakfast frequency could be negatively associated with abdominal obesity, especially among smokers.ANIBES Study was financially supported by Coca Cola Iberia through an agreement with the Spanish Nutrition Foundation (FEN)

Familial hypercholesterolaemia in children and adolescents from 48 countries: a cross-sectional study

Background Approximately 450 000 children are born with familial hypercholesterolaemia worldwide every year, yet only 2·1% of adults with familial hypercholesterolaemia were diagnosed before age 18 years via current diagnostic approaches, which are derived from observations in adults. We aimed to characterise children and adolescents with heterozygous familial hypercholesterolaemia (HeFH) and understand current approaches to the identification and management of familial hypercholesterolaemia to inform future public health strategies. Methods For this cross-sectional study, we assessed children and adolescents younger than 18 years with a clinical or genetic diagnosis of HeFH at the time of entry into the Familial Hypercholesterolaemia Studies Collaboration (FHSC) registry between Oct 1, 2015, and Jan 31, 2021. Data in the registry were collected from 55 regional or national registries in 48 countries. Diagnoses relying on self-reported history of familial hypercholesterolaemia and suspected secondary hypercholesterolaemia were excluded from the registry; people with untreated LDL cholesterol (LDL-C) of at least 13·0 mmol/L were excluded from this study. Data were assessed overall and by WHO region, World Bank country income status, age, diagnostic criteria, and index-case status. The main outcome of this study was to assess current identification and management of children and adolescents with familial hypercholesterolaemia. Findings Of 63 093 individuals in the FHSC registry, 11 848 (18·8%) were children or adolescents younger than 18 years with HeFH and were included in this study; 5756 (50·2%) of 11 476 included individuals were female and 5720 (49·8%) were male. Sex data were missing for 372 (3·1%) of 11 848 individuals. Median age at registry entry was 9·6 years (IQR 5·8–13·2). 10 099 (89·9%) of 11 235 included individuals had a final genetically confirmed diagnosis of familial hypercholesterolaemia and 1136 (10·1%) had a clinical diagnosis. Genetically confirmed diagnosis data or clinical diagnosis data were missing for 613 (5·2%) of 11 848 individuals. Genetic diagnosis was more common in children and adolescents from high-income countries (9427 [92·4%] of 10 202) than in children and adolescents from non-high-income countries (199 [48·0%] of 415). 3414 (31·6%) of 10 804 children or adolescents were index cases. Familial-hypercholesterolaemia-related physical signs, cardiovascular risk factors, and cardiovascular disease were uncommon, but were more common in non-high-income countries. 7557 (72·4%) of 10 428 included children or adolescents were not taking lipid-lowering medication (LLM) and had a median LDL-C of 5·00 mmol/L (IQR 4·05–6·08). Compared with genetic diagnosis, the use of unadapted clinical criteria intended for use in adults and reliant on more extreme phenotypes could result in 50–75% of children and adolescents with familial hypercholesterolaemia not being identified. Interpretation Clinical characteristics observed in adults with familial hypercholesterolaemia are uncommon in children and adolescents with familial hypercholesterolaemia, hence detection in this age group relies on measurement of LDL-C and genetic confirmation. Where genetic testing is unavailable, increased availability and use of LDL-C measurements in the first few years of life could help reduce the current gap between prevalence and detection, enabling increased use of combination LLM to reach recommended LDL-C targets early in life. Funding Pfizer, Amgen, Merck Sharp & Dohme, Sanofi–Aventis, Daiichi Sankyo, and Regeneron

Anticoagulant selection in relation to the SAMe-TT2R2 score in patients with atrial fibrillation. the GLORIA-AF registry

Aim: The SAMe-TT2R2 score helps identify patients with atrial fibrillation (AF) likely to have poor anticoagulation control during anticoagulation with vitamin K antagonists (VKA) and those with scores &gt;2 might be better managed with a target-specific oral anticoagulant (NOAC). We hypothesized that in clinical practice, VKAs may be prescribed less frequently to patients with AF and SAMe-TT2R2 scores &gt;2 than to patients with lower scores. Methods and results: We analyzed the Phase III dataset of the Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF), a large, global, prospective global registry of patients with newly diagnosed AF and ≥1 stroke risk factor. We compared baseline clinical characteristics and antithrombotic prescriptions to determine the probability of the VKA prescription among anticoagulated patients with the baseline SAMe-TT2R2 score &gt;2 and ≤ 2. Among 17,465 anticoagulated patients with AF, 4,828 (27.6%) patients were prescribed VKA and 12,637 (72.4%) patients an NOAC: 11,884 (68.0%) patients had SAMe-TT2R2 scores 0-2 and 5,581 (32.0%) patients had scores &gt;2. The proportion of patients prescribed VKA was 28.0% among patients with SAMe-TT2R2 scores &gt;2 and 27.5% in those with scores ≤2. Conclusions: The lack of a clear association between the SAMe-TT2R2 score and anticoagulant selection may be attributed to the relative efficacy and safety profiles between NOACs and VKAs as well as to the absence of trial evidence that an SAMe-TT2R2-guided strategy for the selection of the type of anticoagulation in NVAF patients has an impact on clinical outcomes of efficacy and safety. The latter hypothesis is currently being tested in a randomized controlled trial. Clinical trial registration: URL: https://www.clinicaltrials.gov//Unique identifier: NCT01937377, NCT01468701, and NCT01671007

Comparative effectiveness and safety of non-vitamin K antagonists for atrial fibrillation in clinical practice: GLORIA-AF Registry

Background and purpose: Prospectively collected data comparing the safety and effectiveness of individual non-vitamin K antagonists (NOACs) are lacking. Our objective was to directly compare the effectiveness and safety of NOACs in patients with newly diagnosed atrial fibrillation (AF). Methods: In GLORIA-AF, a large, prospective, global registry program, consecutive patients with newly diagnosed AF were followed for 3&nbsp;years. The comparative analyses for (1) dabigatran vs rivaroxaban or apixaban and (2) rivaroxaban vs apixaban were performed on propensity score (PS)-matched patient sets. Proportional hazards regression was used to estimate hazard ratios (HRs) for outcomes of interest. Results: The GLORIA-AF Phase III registry enrolled 21,300 patients between January 2014 and December 2016. Of these, 3839 were prescribed dabigatran, 4015 rivaroxaban and 4505 apixaban, with median ages of 71.0, 71.0, and 73.0&nbsp;years, respectively. In the PS-matched set, the adjusted HRs and 95% confidence intervals (CIs) for dabigatran vs rivaroxaban were, for stroke: 1.27 (0.79–2.03), major bleeding 0.59 (0.40–0.88), myocardial infarction 0.68 (0.40–1.16), and all-cause death 0.86 (0.67–1.10). For the comparison of dabigatran vs apixaban, in the PS-matched set, the adjusted HRs were, for stroke 1.16 (0.76–1.78), myocardial infarction 0.84 (0.48–1.46), major bleeding 0.98 (0.63–1.52) and all-cause death 1.01 (0.79–1.29). For the comparison of rivaroxaban vs apixaban, in the PS-matched set, the adjusted HRs were, for stroke 0.78 (0.52–1.19), myocardial infarction 0.96 (0.63–1.45), major bleeding 1.54 (1.14–2.08), and all-cause death 0.97 (0.80–1.19). Conclusions: Patients treated with dabigatran had a 41% lower risk of major bleeding compared with rivaroxaban, but similar risks of stroke, MI, and death. Relative to apixaban, patients treated with dabigatran had similar risks of stroke, major bleeding, MI, and death. Rivaroxaban relative to apixaban had increased risk for major bleeding, but similar risks for stroke, MI, and death. Registration: URL: https://www.clinicaltrials.gov. Unique identifiers: NCT01468701, NCT01671007. Date of registration: September 2013