Are we ready yet for digital transformation? Virtual versus on-campus OSCE as assessment tools in pharmacy education. A randomized controlled head-to-head comparative assessment.

Background: The global COVID-19 pandemic has influenced pharmacy education including learning, assessment, and exams. In the UAE, pharmacy instructors have adapted several innovative teaching methods to strive for quality learning outcomes. The current trial presented a head-to-head comparative assessment between on-campus versus virtual Objective Structured Clinical Examination (OSCE) with examiners' and students' perspectives. Aim: The main aim was to compare fourth-year students' and examiners' perceptions of the feasibility (time and logistics), stress, performance, and satisfaction between on-campus versus virtual OSCE. Method: A randomized controlled head-to-head comparative assessment between the On-campus and virtual OSCE was conducted to explore performance and satisfaction of pharmacy students and examiners towards the two OSCE settings. The virtual OSCE was carried out directly after the on-campus -OSCE and the setting was designed in a way that aligned with the on-campus OSCE but in a virtual way. Microsoft Teams® breakout room was used as a virtual stations. Respondus-lockdown-browse and Google Meet® were used for proctoring purposes. Results: Students who sat for the on-campus assessment were more satisfied with the instructions, the orientation session, the time management, and the overall exam setting, the ability of the exam to assess their communication and clinical skills, professionalism and attitude, and the interactivity of the exam compared to the students who sat for the virtual assessment. Examiners' perceptions for both settings were the same with the exception of interaction with students (p less than 0.05) as the on-campus OSCE was more interactive. Conclusion: Students still prefer the on-campus OSCE to the virtual OSCE format in many aspects. Nevertheless, virtual OSCE is still a feasible and satisfactory method of assessment when on-campus OSCE is not possible. There is a need of a specialized platform to conduct the virtual OSCE from A to Z rather than maximizing the use of options in the current digital platforms.

Risk factors for coronary artery disease in patients undergoing elective coronary angiography in Jordan.

BACKGROUND: Unhealthy lifestyle factors such as smoking, obesity, inactivity and type 2 diabetes are endemic in the Middle East. The public health consequences might be detrimental; however, local studies on risk factors for coronary artery disease (CAD) are scarce. METHODS: Patients referred for coronary angiography at a tertiary hospital in Amman, Jordan, between January and December 2015, were included in this study. Risk factors for CAD were assessed in a multivariate logistic regression model, and presented as odds ratio (OR) with 95% confidence interval (CI). RESULTS: Among 557 participants, 356 (63.9%) had CAD and 201 (36.1%) had a normal cardiogram. The majority (n = 395, 70.9%) were male, and median age was 55 years (interquartile range 47-64). Two-hundred-and-fifteen (38.6%) individuals reported previous diabetes, and 287 (51.5%) were current or previous smokers. In multivariate analysis, male gender (OR 3.7, 95% CI 2.3-6.0), age (45-54 years: OR 4.8, 95% CI 2.7-8.5; 55-64 years: OR 6.0, 95% CI 3.2-11.4; ≥65 years: OR 15.7, 95% CI 7.8-31.3), previous diabetes (OR 2.6, 95% CI 1.7-4.1) and current/previous smoking (OR 2.1, 95% CI 1.3-3.4) were significant predictors of CAD. CONCLUSIONS: Age, gender, diabetes and smoking were strong and significant risk factors for CAD in Jordan. Public health interventions to reduce the prevalence of smoking and diabetes are urgently needed.

Association between mass media and body weight concern among Jordanian adolescents' residents of Amman: the role of gender and obesity.

OBJECTIVES: Body image in the mass media promotes an unrealistic picture of body shape that leads to body dissatisfaction among adolescentsQuery. Therefore, the study presented in this paper aimed to assess the association between mass media and adolescents' weight concerns and perceptions of body weight and shape. METHODS: A cross-sectional survey was conducted on school adolescents aged between 15 and 18 years during the academic year 2013-2014. Multistage stratified sampling method was used. The number of participants in the study was 795 students: 400 boys and 395 girls. RESULTS: All participants have a common behavior in rarely reading magazines, but they spend more than 2 h in watching television or less than 3 h using the internet. However, most of obese/non-obese adolescents, boys or girls, have shown high influence (p < 0.05) of reading magazines on the subject of dieting to lose weight. CONCLUSION: While obese students read more magazines on dieting to lose weight, other mass media did not show the same results on weight concerns and body shape among Jordanian adolescents.

Apolipoprotein E Genetic Variant and Blood Lipid Responses to Plant Sterols: A Systematic Review and Pooled Analysis of Clinical Trials.

Plant sterols/stanols are effective cholesterol-lowering agents. However, it is unclear whether the apolipoprotein E (ApoE) genetic variants influence it. We investigated whether ApoE genetic variants modulate the responses of blood lipids to dietary intervention plant sterols/stanols in adults and if the intervention dose and duration, as well as the age and status of participants, influence this effect. Randomized clinical trials were identified by searching databases in the Cochrane Library. Random-effect models were used to estimate the pooled effect size of each outcome of interest total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein cholesterol, and triglycerides. Meta-regression and subgroup analysis were used to investigate the effects of potential modifiers on the outcomes of interest. Eleven articles were selected from 3,248 retrieved abstracts. Plant sterol/stanol intervention was associated with a more significant reduction in LDL levels in the E3 group [-0.251 mmol/L; 95% confidence interval (95% CI), -0.488 to -0.015] compared with both the E4 and E2 groups. In E4 carriers, the plant sterol/stanol intervention dose and duration resulted in a larger decrease in LDL levels (-0.088027 mmol/L; 95% CI, -0.154690 to -0.021364). In conclusion, ApoE genetic variants affected the response of blood LDL levels to supplementation with plant sterols/stanols, as individuals with E3 variant showed significantly decreased LDL levels compared with the other genotypes. However, future studies recruiting participants according to their ApoE genetic variants are needed to confirm our conclusion.

Association of obesity with COVID-19 diseases severity and mortality: A meta-analysis of studies.

Background: The literature on COVID-19 infection is growing every single day, and evidence of presence or absence of association between obesity and COVID-19 adverse outcomes should be revisited. Therefore, this study summarizes the pooled association of obesity with COVID-19 adverse outcomes and mortality. Methods: We searched PubMed and Science direct databases using specific terms and defined criteria. Data were analyzed using Comprehensive Meta-Analysis V2 (Biostat, Englewood, NJ, USA)) random-effect models were used to calculate the odds ratio (OR) with 95% confidence intervals (95% CIs) of infection severity and mortality associated with obesity. Results: Results revealed that obesity is not associated with COVID-19 mortality (OR = 1.1; 95%CI: 0.8 to 1.3) but with other adverse outcomes (OR = 2.4; 95%CI: 1.7 to 3.3). Conclusion: Our findings support previous findings that obesity is associated with COVID-19 severity.

Associations of pre-existing cardiovascular morbidity with severity and the fatality rate in COVID-19 patients: a systematic review and meta-analysis.

Objectives: The aim of this study was to evaluate the association of pre-existing cardiovascular comorbidities, including hypertension and coronary heart disease, with coronavirus disease 2019 (COVID-19) severity and mortality. METHODS: PubMed, ScienceDirect, and Scopus were searched between January 1, 2020, and July 18, 2020, to identify eligible studies. Random-effect models were used to estimate the pooled event rates of pre-existing cardiovascular disease comorbidities and odds ratio (OR) with 95% confidence intervals (95% CIs) of disease severity and mortality associated with the exposures of interest. RESULTS: A total of 34 studies involving 19,156 patients with COVID-19 infection met the inclusion criteria. The prevalence of pre-existing cardiovascular disease in the included studies was 14.0%. Pre-existing cardiovascular disease in COVID-19 patients was associated with severe outcomes (OR, 4.1; 95% CI, 2.9 to 5.7) and mortality (OR, 6.1; 95% CI, 2.9 to 12.7). Hypertension and coronary heart disease increased the risk of severe outcomes by 2.6 times (OR, 2.6; 95% CI, 1.9 to 3.6) and 2.5 times (OR, 2.5; 95% CI, 1.7 to 3.8), respectively. No significant publication bias was indicated. Conclusion: COVID-19 patients with pre-existing cardiovascular comorbidities have a higher risk of severe outcomes and mortality. Awareness of pre-existing cardiovascular comorbidity is important for the early management of COVID-19.

The ratio of eicosapentaenoic acid to docosahexaenoic acid as a modulator for the cardio-metabolic effects of omega-3 supplements: A meta-regression of randomized clinical trials.

BACKGROUND: A large number of studies have demonstrated the effects of omega- 3 supplements containing mixtures of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), known to favorably affect many modifiable risk factors of coronary heart disease (CHD). These studies have used diverse ratios and doses of EPA and DHA. However, it is not known whether the ratio of EPA to DHA in omega-3 supplements affect their efficacy as modulators for cardiovascular risk factors. This meta-regression aimed to investigate the effect of different ratios of EPA to DHA on risk factors associated with CHD including lipid profile, blood pressure, heart rate, and inflammation. METHOD: A regression analysis was carried out on 92 clinical trials with acceptable quality (Jadad score ≥ 3) that were previously identified from two databases (PubMed and Cochrane Library). RESULTS: Data from studies that met the inclusion criteria for this analysis showed that the ratio of EPA to DHA was not associated with lipid profile, diastolic blood pressure, or heart rate. With all studies, the ratio of EPA to DHA was associated with C-reactive protein (CRP) (ß = -1.3121 (95 % CI: -1.6610 to -0.9543), that is, the higher the EPA to DHA ratio, the greater the reduction. Using only studies that supplied EPA and DHA in the range of 2 g-6 g, the ratio of EPA to DHA was also associated with CRP (ß = -2.10429 and 95 % CI: -3.89963 to -0.30895); that is, an even more pronounced reduction in CRP with a higher EPA to DHA ratio. Systolic blood pressure was only associated with an increasing EPA to DHA ratio in the 2 g-6 g range (ß = 5.47129 and 95 % CI: 0.40677-10.53580), that is, a higher EPA to DHA ratio within this dose range, the greater the increase in SBP. CONCLUSION: Current data suggest that the EPA to DHA ratio only correlates to the modulation of CRP by omega-3 supplementation of EPA and DHA, and SBP in studies that supplemented EPA and DHA in the range of 2 g-6 g, shedding light on potential differential effects of EPA vs. DHA on inflammation and systolic blood pressure.

Cerebrovascular comorbidity, high blood levels of C-reactive protein and D-dimer are associated with disease outcomes in COVID-19 patients.

The emerging coronavirus disease (COVID-19) swept the world, affecting more than 200 countries and territories. As of August 22, 2020, the pandemic infected more than 23,329,752 including 807,054 patients who have died. Although the main clinical features of the pandemic disease are respiratory, cerebrovascular comorbidities emerged as one of the leading causes of death associated with COVID-19. Different case reports have indicated that C-reactive protein (CRP) and D-dimer (pro-inflammatory biomarkers) were elevated in COVID-19 patients, which can significantly increase the risk of ischemic stroke. Available data on cerebrovascular complications in COVID-19 patients were collected and a meta-analysis was designed and carried out to evaluate the risk of severity and mortality associated with high levels of CRP and D-dimer levels in COVID-19 patients. In addition, we aimed to describe the overall event rate of pre-existing cerebrovascular disease in COVID-19 patients. In our analysis, 5,614 cases have been studied, out of these patients 164 cases have developed cerebrovascular comorbities. Cerebrovascular comorbidity increased the risk of disease severity (odd ratio = 4.4; 95% CI: 1.48 to 12.84) and mortality (odd ratio = 7.0; 95% CI: 2.56 to 18.99). Statistical analyses showed that CRP and D-dimer serum levels were elevated by six-folds in the severe cases of COVID-19 patients. This significant increase in these two proteins levels can serve as a vital indicator for COVID-19 patients who are at increased risk of severe COVID-19 cerebrovascular complications, such as stroke.

Phytosterols as functional food ingredients: linkages to cardiovascular disease and cancer.

PURPOSE OF REVIEW: To examine experimental evidence that has examined association of phytosterols and the reduction of the risk of cardiovascular disease and cancer. RECENT FINDINGS: Phytosterols exist as naturally occurring plant sterols that are present in the nonsaponifiable fraction of plant oils. Phytosterols are plant components that have a chemical structure similar to cholesterol except for the addition of an extra methyl or ethyl group; however, phytosterol absorption in humans is considerably less than that of cholesterol. In fact, phytosterols reduce cholesterol absorption, although the exact mechanism is not known, and thus reduce circulating levels of cholesterol. The efficacy of phytosterols as cholesterol-lowering agents have been shown when incorporated into fat spreads as well as other food matrices. In addition, phytosterols have been combined with other beneficial dietary components including fish and olive oils, psyllium and beta-glucan to enhance their effect on risk factors of cardiovascular disease. Phytosterols appear not only to play an important role in the regulation of cardiovascular disease but also to exhibit anticancer properties. A side effect associated with the consumption of phytosterols is that they reduce the blood levels of carotenoid. Nevertheless, it has been suggested that compensation for this impact on serum carotenoid levels can occur either by increasing the intake of carotenoid-rich foods or by taking supplements containing these carotenoids. SUMMARY: Dietary phytosterols appear to play an important role in the regulation of serum cholesterol and to exhibit anticancer properties.

Cholesterol-lowering effect of plant sterols.

Plant sterols are plant components that have a chemical structure similar to cholesterol except for the addition of an extra methyl or ethyl group; however, plant sterol absorption in humans is considerably less than that of cholesterol. In fact, plant sterols reduce cholesterol absorption and thus reduce circulating levels of cholesterol. Earlier studies that have tested the efficacy of plant sterols as cholesterol-lowering agents incorporated plant sterols into fat spreads. Later on, plant sterols were added to other food matrices, including juices, nonfat beverages, milk and yogurt, cheese, meat, croissants and muffins, and cereal and chocolate bars. The beneficial physiologic effects of plant sterols could be further enhanced by combining them with other beneficial substances, such as olive and fish oils, fibers, and soy proteins, or with exercise. The addition of plant sterols to the diet is suggested by health experts as a safe and effective way to reduce the risk of coronary heart disease.

Efficacy of plant sterols is not influenced by dietary cholesterol intake in hypercholesterolemic individuals.

Plant sterols (PSs) reduce plasma total and low-density lipoprotein cholesterol (LDL-C) levels by reducing cholesterol absorption; however, it is not known whether the level of dietary cholesterol intake has an impact on the efficacy of PSs on blood lipids. The purpose of this study was to determine the effect of high vs low dietary cholesterol levels on the lipid-lowering efficacy of free PSs. The study was a semirandomized, double-blind, crossover trial consisting of four 28-day feeding phases each separated by a 4-week washout period. Otherwise healthy hypercholesterolemic subjects (n = 22) consumed each of (a) low-cholesterol control (C(-)S(-)), (b) high-cholesterol control (C(+)S(-)), (c) 22 mg PSs per kilogram of body weight with a low-cholesterol diet (C(-)S(+)), and (d) 22 mg PSs per kilogram of body weight with a high-cholesterol diet (C(+)S(+)). Blood was drawn on the first and last 2 days of each phase to measure plasma total cholesterol, LDL-C, high-density lipoprotein cholesterol, and triacylglycerols as well as plasma campesterol and beta-sitosterol concentrations. Dietary cholesterol had no effect on PS efficacy as a cholesterol-lowering agent because no interaction was found between the 2 factors. However, dietary cholesterol and PS intake had significant independent effects on plasma total cholesterol, LDL-C, and high-density lipoprotein cholesterol levels. beta-Sitosterol levels in plasma increased (P < .0001) as a result of PS supplementation. Data from the present study indicate that, although PSs and dietary cholesterol exert independent effects on plasma cholesterol, PS efficacy is not affected by varying levels of cholesterol intake.

Cholesterol-lowering efficacy of plant sterols in low-fat yogurt consumed as a snack or with a meal.

OBJECTIVE: Plant sterols (PS) consumed as a snack may not have the same cholesterol-lowering potential as when consumed with a meal due to poor solubilization. It was hypothesized that the consumption of a single dose, low-fat yogurt rich in PS (1.6 g/d) with a meal over an afternoon snack will lead to favourable changes in plasma lipids, plasma PS concentrations, and cholesterol synthesis without negatively affecting alpha-tocopherol or carotenoids levels. METHODS: Twenty-six hyperlipidemic males and females completed the randomized trial of three phases (control, single PS dose consumed with a meal, or single PS dose as an afternoon snack) while consuming controlled, low-fat diets. Plasma lipids, cholesterol synthesis rates, plasma PS and serum fat-soluble antioxidants were measured at baseline and after 4 weeks. RESULTS: Endpoint total cholesterol (TC) levels after the PS snack phase were decreased (p = 0.04) (5.30 +/- 0.2 mmol/L) compared to the control phase (5.53 +/- 0.2 mmol/L). However, endpoints for TC (5.37 +/- 0.2 mmol/L) for PS dose with a meal were comparable to control phase. Low-density lipoprotein-cholesterol tended to be different (p = 0.06) at the end of the intervention phases (3.51 +/- 0.1, 3.43 +/- 0.1, and 3.33 +/- 0.1 mmol/L; control, meal and snack, respectively). Cholesterol fractional synthesis rates were higher (p = 0.007) by 25.8% and 19.5% at the end of the snack and meal phases, respectively, compared with the control phase. Plasma campesterol and beta-sitosterol concentrations, adjusted for TC, were higher (p < 0.01) in the snack phase (2.30 +/- 0.3 and 0.54 +/- 0.1 micromol/mmol, respectively) and in the meal phase (2.00 +/- 0.3 and 0.51 +/- 0.1 micromol/mmol, respectively) when compared to the control phase (1.81 +/- 0.3 and 0.40 +/- 0.1 micromol/mmol, respectively). No changes in alpha-tocopherol or carotenoids levels were detected after adjusting for TC, for all phases. CONCLUSION: These results indicate that a single dose of PS in low-fat yogurt, provided as a snack, lowers cholesterol levels but does not alter fat-soluble vitamin or carotenoid concentrations in hyperlipidemic participants.

Triacylglycerol-Lowering Effect of Docosahexaenoic Acid Is Not Influenced by Single-Nucleotide Polymorphisms Involved in Lipid Metabolism in Humans.

The triacylglycerol (TAG)-lowering effects of long-chain n-3 fatty acids, and in particular docosahexaenoic acid (DHA), are well documented, although these effects manifest large interindividual variability. The objective of this secondary analysis is to investigate whether common single-nucleotide polymorphisms (SNP) in genes involved in DHA synthesis and TAG metabolism are associated with the responsiveness of blood lipids, lipoprotein, and apolipoprotein concentration to dietary treatment by DHA supplied in high-oleic canola oil (HOCO). In a randomized, crossover-controlled feeding trial, 129 subjects with metabolic syndrome received high-oleic canola oil (HOCO) and high-oleic canola oil supplemented with DHA (HOCO-DHA), each for 4 weeks. During the HOCO-DHA phase, the intake of DHA ranged from 1 to 2.5 g/day. The subjects were genotyped for apolipoprotein E (APOE) isoforms, and SNP including FADS1-rs174561, FADS2-rs174583, ELOVL2-rs953413, ELOVL5-rs2397142, CETP-rs5882, SCD1-rs2234970, PPARA-rs6008259, and LIPF-rs814628 were selected as important genes controlling fatty acid metabolism. Overall, consumption of HOCO-DHA oil reduced blood concentrations of TAG by 24% compared to HOCO oil. The reduction in TAG was independent of genetic variations in the studied genes. Similarly, no treatment-by-gene interactions were evident in the response to other lipids, lipoproteins, or apolipoproteins to DHA supplementation. Nevertheless, a lower interindividual variation in the TAG response to DHA supplementation compared to other studies was observed in this analysis. The TAG-lowering effect of a supplemental body-weight-based dose of DHA was not influenced by genetic variations in APOE, FADS1, FADS2, ELOVL2, ELOVL5, CETP, SCD1, PPARA, and LIPF.

Physiological and therapeutic factors affecting cholesterol metabolism: does a reciprocal relationship between cholesterol absorption and synthesis really exist?

Cholesterol absorption and synthesis contribute to maintaining cholesterol homeostasis. Several physiological and therapeutic factors affect cholesterol homeostasis, including: genetics, circadian rhythm, body weight, plant sterols, ezetimibe, and statin therapy. The present objective is to determine the main vector, i.e. cholesterol absorption or synthesis, affected by each of these factors, and to examine whether an alteration in one vector is linked to a reciprocal change in the other. Current techniques used to assess cholesterol absorption and synthesis are also reviewed. Review of physiological factors affecting cholesterol metabolism suggest a reciprocal relationship between these two vectors. Carriers of the E2 isoform of apolipoprotein E and ATP binding cassette (ABC) G8 19H (exon 1 mutation) show a decrease in cholesterol absorption accompanied by a corresponding increase in synthesis. Circadian rhythm affects cholesterol synthesis, however, its effect on absorption has yet to be established. Obese subjects show an increase in cholesterol synthesis with a subsequent decrease in cholesterol absorption. Weight loss down regulates cholesterol synthesis, but has little or no effect on absorption. In the case of therapeutic factors, plant sterols and stanols inhibit cholesterol absorption, which results in a compensatory increase in synthesis. Ezetimibe also decreases intestinal absorption, while reciprocally increasing synthesis. Statin therapy down regulates synthesis, which is accompanied by a rise in absorption. These findings suggest that a change in one vector, fairly consistently, results in a compensatory and opposing change in the other. An understanding of this reciprocal relationship between cholesterol absorption and synthesis may allow for the development of more effective interventions for dyslipidemic disorders.

Dietary patterns and colorectal cancer.

BACKGROUND & AIMS: Dietary pattern and lifestyle have been reported to be important risk factors in the development of colorectal cancer (CRC). However, the mechanism of action of dietary factors in CRC disease is unclear. The aim of this study is the examination of several dietary choices and their potential association with the risk of developing CRC. METHODS: Dietary data was collected from 220 subjects who were previously diagnosed with CRC, and 281 control subjects (matched by age, gender, occupation and marital status). The data was collected between January 2010 and December 2012, using interview-based questionnaires. Multivariate logistic regression was used to estimate the relationship between dietary choices and risk of developing colorectal cancer. RESULTS: Factor analysis revealed three major dietary patterns. The first pattern we identified as the "Healthy Pattern", the second was identified as "High Sugar/High Tea Pattern" and the third as "Western Pattern". In the Healthy Pattern group we found a 10.54% variation in food intake, while the intake variation was 11.64% in the Western Pattern. After adjusting for confounding factors, the Western Pattern food choice was found to be significantly associated with an increased risk of developing CRC (OR = 1.88; 95% CI = 1.12-3.16). The results for the Healthy and High-Sugar/High Tea Patterns showed a decrease, but the statistic was not significant for the risk of CRC development. CONCLUSION: The Western Pattern of dietary choice was directly associated with CRC. The association between the dietary food choice in the Healthy and High-Sugar/High Tea Patterns and colorectal cancer needs further study in our Jordanian population.

Plant sterols: factors affecting their efficacy and safety as functional food ingredients.

Plant sterols are naturally occurring molecules that humanity has evolved with. Herein, we have critically evaluated recent literature pertaining to the myriad of factors affecting efficacy and safety of plant sterols in free and esterified forms. We conclude that properly solubilized 4-desmetyl plant sterols, in ester or free form, in reasonable doses (0.8-1.0 g of equivalents per day) and in various vehicles including natural sources, and as part of a healthy diet and lifestyle, are important dietary components for lowering low density lipoprotein (LDL) cholesterol and maintaining good heart health. In addition to their cholesterol lowering properties, plant sterols possess anti-cancer, anti-inflammatory, anti-atherogenicity, and anti-oxidation activities, and should thus be of clinical importance, even for those individuals without elevated LDL cholesterol. The carotenoid lowering effect of plant sterols should be corrected by increasing intake of food that is rich in carotenoids. In pregnant and lactating women and children, further study is needed to verify the dose required to decrease blood cholesterol without affecting fat-soluble vitamins and carotenoid status.

Implementing phytosterols into medical practice as a cholesterol-lowering strategy: overview of efficacy, effectiveness, and safety.

More than 200 clinical trial reports and several meta-analyses have demonstrated that phytosterols (PSs), natural components of plants, induce clinically relevant reductions in blood low-density lipoprotein cholesterol levels. Here we review data regarding the biochemical effects and potential cardiovascular benefit of PSs as part of the dietary management of dyslipidemia. In addition to discussing the efficacy, effectiveness, and safety of PSs as hypocholesterolemic agents, this review provides an overview of PSs as an adjunctive therapy to cholesterol-lowering pharmaceuticals. Given this lack of evidence regarding the benefits of PSs for reducing cardiovascular end points, this review also discusses the present knowledge that exists about the ability for therapeutic dosages of PSs to confer protection from cardiovascular-related mortality and morbidity. Finally, this review summarizes the factors that affect PS efficacy and the Canadian regulations that govern the use of PSs as cholesterol-lowering agents in foods and supplements.

Cholesterol-lowering efficacy of plant sterols/stanols provided in capsule and tablet formats: results of a systematic review and meta-analysis.

Plant sterols/stanols-enriched foods possess well-documented low-density lipoprotein (LDL)-cholesterol-lowering effect. However, the relative efficacy of plant sterols/stanols as supplements (tablets/capsules) compared with other dietary forms still needs to be determined. Our aim was to precisely identify and quantify the LDL-cholesterol-lowering effect of plant sterols/stanols as supplements in contrast to food-based approaches. Eight eligible clinical trials published from January 1992 to April 2013 were identified from five databases. A random effect model was used to calculate weighted mean effect sizes for net differences in LDL-cholesterol concentrations. Among the included trials with the duration between 4 and 6 weeks, plant sterol/stanol dose ranged from 1.0 to 3.0 g/day administrated mainly with the main meals (2 or 3 times/day). Intake of plant sterol/stanol supplements decreased LDL-cholesterol concentrations by 12 mg/dL (0.31 mmol/L) (95% CI -0.39 to -0.23; P<0.000) compared with placebo. The test of heterogeneity was not significant (χ(2) , P=0.50, I(2)=0%). Further analysis showed no significant difference between the LDL-cholesterol-lowering action of plant sterols/stanols supplements (-12 mg/dL [-0.31 mmol/L]; 95% CI -0.39 to -0.24; P<0.0001) vs foods enriched with plant sterols/stanols (-12 mg/dL [-0.31 mmol/L]; 95% CI -0.35 to -0.27; P<0.0001). Plant sterol/stanol supplements as part of a healthy diet represent an effective means of delivering LDL-cholesterol-lowering similar to plant sterols/stanols delivered in various food formats.

Physical inactivity, water intake and constipation as risk factors for colorectal cancer among adults in Jordan.

BACKGROUND: Physical activity has been found to play a role in cancer prevention. The purpose of this matched case-control study was to investigate the association between physical activity levels, water intake, constipation and colorectal cancer (CRC). MATERIALS AND METHODS: Two hundred and thirty-two patients diagnosed with CRC (125 male, 107 female) were enrolled in this case-control study. Cases were matched to 271 population controls (137 male, 134 female). RESULTS: Drinking more than 4 cups of water daily decreased the risk of CRC by 33-42%; however, this effect was non-significant. Having constipation was found to be a significant risk factor for developing CRC with an OR=6.284 (95%CI=2.741-14.40). With reference to sedentary behavior, minimum activity (600-3000 Metabolic Equivalents Task (MET)) had 43% protection against CRC and the level of Health Enhancing Physical Activity OR was 0.58 (at 95%CI; 0.37-0.92). A significant negative association was found between CRC and physical activity levels expressed as both METs and MET-hours/week (p for trend=0.017 and 0.03, respectively). Among females, a significant trend of reduction in CRC by 62% was observed with increasing the level of physical activity expressed in MET (p for trend=0.04). CONCLUSIONS: The risk of CRC may be reduced by adopting a healthy lifestyle and practicing physically activity regularly, especially among females. Consuming adequate amounts of water and healthy bowel motility could also reduce the risk of CRC.

Optimizing clinical trial design for assessing the efficacy of functional foods.

Randomized clinical trial data are capable of providing strong experimental evidence to establish causal relationships between functional food components and health and disease/disease risk. However, clinical studies must be well designed in order to optimize the quality of the data they provide. The purpose of this review is to identify design elements that maximize the quality of clinical trials examining the efficacy of functional foods. Both observational studies and experimental trials can provide useful data for identifying diet-disease relationships. Two experimental designs are conventionally used: parallel and crossover. Each of these designs possesses advantages and disadvantages. For certain functional ingredients, selection of an appropriate control arm is straightforward, while for others it is challenging. Studies should be short enough to optimize subject compliance, be cost effective, and avoid high subject dropout rates, while being lengthy enough to ensure biological efficacy. The dose, frequency, and diurnal timing of intake of the active food ingredient all need to be chosen carefully. Randomized clinical trials testing the efficacy of functional foods may use both validated and emerging surrogate endpoints and should employ suitable statistical tests for data analysis. Paying attention to all these factors is crucial to the design of quality clinical trials that reliably evaluate food-health relationship validity. Accordingly, clinical studies that incorporate the optimal design elements discussed will yield robust results appropriate for the substantiation of health claims on functional foods.