Improvements In LDL Cholesterol Research Articles

Medical Assistant Health Coaching for Type 2 Diabetes in Primary Care: Results From a Pragmatic Cluster Randomized Controlled Trial.

This cluster (clinic-level) randomized controlled trial (RCT) compared medical assistant (MA) health coaching (MAC) with usual care (UC) among at-risk adults with type 2 diabetes in two diverse real-world primary care environments: a federally qualified health center (FQHC; Neighborhood Healthcare) and a large nonprofit private insurance-based health system (Scripps Health). A total of 600 adults with type 2 diabetes who met one or more of the following criteria in the last 90 days were enrolled: HbA1c ≥8% and/or LDL cholesterol ≥100 mg/dL and/or systolic blood pressure (SBP) ≥140 mmHg. Participants at MAC clinics received in-person and telephone self-management support from a specially trained MA health coach for 12 months. Electronic medical records were used to examine clinical outcomes in the overall sample. Behavioral and psychosocial outcomes were evaluated in a subsample (n = 300). All clinical outcomes improved significantly over 1 year in the overall sample (P < 0.001). The reduction in HbA1c was significantly greater in the MAC versus UC group (unstandardized Binteraction = -0.06; P = 0.002). A significant time by group by site interaction also showed that MAC resulted in greater improvements in LDL cholesterol than UC at Neighborhood Healthcare relative to Scripps Health (Binteraction = -1.78 vs. 1.49; P < 0.05). No other statistically significant effects were observed. This was the first large-scale pragmatic RCT supporting the real-world effectiveness of MAC for type 2 diabetes in U.S. primary care settings. Findings suggest that this team-based approach may be particularly effective in improving diabetes outcomes in FQHC settings.

Two-Year Follow-Up of Chronic Ischemic Heart Disease Patients in a Specialized Center in Brazil.

The incidence of cardiovascular events in patients with chronic ischemic heart disease (CIHD) may vary significantly among countries. Although populous, Brazil is often underrepresented in international records. This study aimed to describe the quality of care and the two-year incidence of cardiovascular events and associated prognostic factors in CIHD patients in a tertiary public health care center in Brazil. Patients with CIHD who reported for clinical evaluation at Instituto do Coração (São Paulo, Brazil) were registered and followed for two years. The primary endpoint was a composite of myocardial infarction (MI), stroke, or death. A significance level of 0.05 was adopted. From January 2016 to December 2018, 625 participants were included in the study. Baseline characteristics show that 33.1% were women, median age 66.1 [59.6 - 71.9], 48.6% had diabetes, 83.1% had hypertension, 62.6% had previous MI, and 70.4% went through some revascularization procedure. At a median follow-up (FU) of 881 days, we noted 37 (7.05%) primary endpoints. After adjustments, age, previous stroke, and LDL-cholesterol were independently associated with the primary endpoint. Comparing baseline versus FU, participants experienced relief of angina based on the Canadian Cardiovascular Society (CCS) scale according to the following percentages: 65.7% vs. 81.7% were asymptomatic and 4.2% vs. 2.9% CCS 3 or 4 (p < 0.001). They also experienced better quality of medication prescription: 65.8% vs. 73.6% (p < 0.001). However, there was no improvement in LDL-cholesterol or blood pressure control. This study shows that CIHD patients had a two-year incidence of the primary composite endpoint of 7.05%, and the reduction of LDL-cholesterol was the only modifiable risk factor associated with prognosis.

1616-P: Effects of Hazelnuts Consumption Combined with Physical Activity on Lipid Metabolism and Correlations with Marrow Adiposity Homeostasis

Consumption of hazelnuts has been associated with reduced cardiovascular risk and improved metabolic outcomes. Furthermore, the Bone Marrow Fat (BMF) might contribute to skeletal as well as systemic metabolism, modulating insulin sensitivity and, consequently, cardiovascular risk. Previously, we demonstrated a beneficial effect of hazelnuts and cocoa integration on vascular reactivity and metabolic profile in healthy individuals. Aim of this randomized controlled interventional study with 3 parallel groups was to investigate the effects of a daily supplementation with 30 g of hazelnuts, with or without aerobic physical activity (PA), throughout 8 weeks, on insulin sensitivity and resistance, lipid profile, and on BMF content (evaluated by proton magnetic resonance spectroscopy) in healthy individuals. Twenty-five adults (age 18-50 yrs; BMI 18-28 Kg/m2) were randomized in 3 groups: 9 subjects (5F/4M, age 25.6±8.8 yrs, BMI 23.3±2.5) received 30 g of hazelnuts associated with diet (Group 1); 9 subjects (6F/3M, age 26.3±6.3 yrs, BMI 22.0±2.1) received 30 g of hazelnuts associated with diet and aerobic PA (Group 2); 7 subjects (4 F/3 M, age 29.7±6.4 yrs, BMI 23.3±4.2) received only diet (Group 3). After the 8 weeks-intervention, an improvement in LDL-Cholesterol was found in Groups 1 and 2 [-9.3±11.5% (Group 1) vs -5.0±13.6% (Group 2) vs +21.9±35.7% (Group 3); p=0.02]. BMF content variation negatively correlated with LDL-Cholesterol change in Group 1 (r=-0.802, p=0.054); variations in BMF content and in HDL-Cholesterol positively correlated in Group 2 (r=+0.8687, p=0.011). This study confirms the beneficial effects of hazelnuts, in association with PA in improving lipid profile. The correlations between HDL- and LDL-cholesterol and BFM changes suggest an impact of bone homeostasis on whole-body lipid metabolism, through a rapid utilization of lipids, drawing them out of the circulation and decreasing their deposition in the organ tissues. Disclosure A.Ferrulli: None. S.Massarini: None. C.Macrì: None. P.Senesi: None. I.Terruzzi: None. G.Rosso: Employee; Soremartec Italia Srl, Ferrero Group. M.Charron: Employee; Soremartec Italia Srl, Ferrero Group. R.Menta: Employee; Soremartec Italia Srl, Ferrero Group. L.Luzi: Advisory Panel; Eli Lilly and Company, Medtronic, Research Support; Gelesis, Speaker's Bureau; A. Menarini Diagnostics, Amgen Inc., Boehringer Ingelheim and Eli Lilly Alliance, Eli Lilly and Company, Novo Nordisk, Novartis. Funding IRCCS MultiMedica (Ricerca Corrente)

Consumption of kefir made with traditional microorganisms resulted in greater improvements in LDL cholesterol and plasma markers of inflammation in males when compared to a commercial kefir: a randomized pilot study.

Kefir has long been associated with health benefits; however, recent evidence suggests that these benefits are dependent on the specific microbial composition of the kefir consumed. This study aimed to compare how consumption of a commercial kefir without traditional kefir organisms and a pitched kefir containing traditional organisms affected plasma lipid levels, glucose homeostasis, and markers of endothelial function and inflammation in males with elevated LDL cholesterol. We utilized a crossover design in n = 21 participants consisting of two treatments of 4 weeks each in random order separated by a 4-week washout. Participants received either commercial kefir or pitched kefir containing traditional kefir organisms for each treatment period. Participants consumed 2 servings of kefir (350 g) per day. Plasma lipid profile, glucose, insulin, markers of endothelial function, and inflammation were measured in the fasting state before and after each treatment period. Differences within each treatment period and comparison of treatment delta values were performed using paired t tests and Wilcoxon signed-rank test, respectively. When compared to baseline, pitched kefir consumption reduced LDL-C, ICAM-1, and VCAM-1, while commercial kefir consumption increased TNF-α. Pitched kefir consumption resulted in greater reductions in IL-8, CRP, VCAM-1, and TNF-α when compared to commercial kefir consumption. These findings provide strong evidence that microbial composition is an important factor in the metabolic health benefits associated with kefir consumption. They also provide support for larger studies examining these to assess whether traditional kefir organisms are necessary to confer health benefits to individuals at risk of developing cardiovascular disease.

A Pilot Plant Based Dietary Intervention in MGUS and SMM Patients with Elevated BMI Is Feasible and Associated with Improvements in Metabolic and Microbiome Biomarkers of Progression

Introduction Obesity, low adiponectin, high leptin, high insulin, high IGF-1, and diets lacking plant-based foods or high in insulinemic foods are all risk factors for plasma cell disorders (PCDs). Patients (pts) with monoclonal gammopathy (MGUS) and an elevated body mass index (BMI) are twice as likely to progress from MGUS to multiple myeloma (MM). Additionally, there is gut dysbiosis in pts with PCDs, and whole food plant-based diets (WFPBDs) increase stool butyrate concentrations. Butyrate has anti-cancer (HDAC and NFkB inhibition) and anti-inflammatory (proinflammatory cytokine inhibition) properties. Prior studies show that increased relative abundance of stool butyrate producers are associated with improved outcomes in PCDs. Therefore, there is a rationale to study a dietary intervention in MGUS/smoldering MM (SMM), given the standard of care is observation despite the risk of progression. Methods Therefore, we initiated a pilot dietary intervention study (NUTRIVENTION) of a WFPBD in MGUS/SMM pts with BMI ≥25 (NCT04920084) with the primary objective of determining feasibility, as measured by weight loss (>5%) and adherence (>70%) at 12 weeks (wks). Here, we present interim results on feasibility, metabolic markers (insulin, adiponectin leptin ratio, IGF-1), microbiome (relative abundance of butyrate producers, short chain fatty acids) and secreted inflammatory biomarkers (CRP, Olink proteomics) for pts analyzed to date. The intervention, consisting of fully prepared WFPBD meals and behavioral coaching was provided by Plantable. Patients received self-selected WFPBD meals (lunch/dinner) for 12 wks, along with guidance for snacks and breakfast. Behavioral counseling was provided by health coaches and a research dietitian for 24 wks. Adherence was calculated as the percentage of kcal that were whole unprocessed plant foods out of total kcal consumed. Plasma total adiponectin, leptin, IGF-1 and insulin were measured via ELISA immunoassays. Stool samples were analyzed with 16S sequencing and gas chromatography mass spectrometry for short chain fatty acids and plasma was analyzed with the Olink Target 96 inflammation panel. We calculated the median at baseline and the median change % (median change/median at baseline) at 4 and 12 wks. Results The study has completed enrollment of 22 pts (2 dropped out within 12 wks for pt preference and were replaced), with 14 having completed the 12-wk intervention. The baseline demographics for 22 pts include median age 62 years (range 40-79), 45% male, 45% minorities (black, Hispanic, or other), 50% MGUS, 77% obese, and 27% prediabetic/diabetic. Preliminary results for clinical and correlative endpoints are provided in table 1. The study met both feasibility endpoints with 7% median BMI reduction and 90% median adherence at 12 wks as described in table 1. Metabolic markers indicate an improvement in LDL cholesterol, HgbA1c, insulin and adiponectin leptin (AL) ratio. The AL ratio is a marker of insulin resistance and higher levels imply improved insulin sensitivity, reduced BMI, and inflammation. Increased insulin, leptin, IGF-1 as well as decreased adiponectin are associated with the development of MM. Microbiome shows an improvement in the relative abundance of butyrate producers at 4 wks and stool butyrate concentrations at 12 wks. Additionally, a decrease in the branched chain fatty acids are seen. There is a decrease in the proinflammatory cytokines IL8, IL12B and TNFB, a decrease in DNER, a NOTCH1 activator and an increase in the protein FGF21 that is known to promote insulin sensitivity and downregulate hepatic IGF-1 production. Butyrate is known to inhibit the formation of proinflammatory cytokines and increase FGF21 via HDAC inhibition and inhibit NOTCH signaling. Conclusions This is the first interventional study in PCDs with mechanistic insights into risk reduction through modifiable risk factors with the potential to empower pts. Preliminary results show that a WFPBD is feasible given the BMI reduction and adherence in pts with PCDs. Our data suggests that a WFPBD improves metabolic profile (BMI, insulin resistance, AL ratio and FGF21) as well as increases stool butyrate producers and butyrate levels which in turn leads to a reduction in proinflammatory cytokines. Positive changes in metabolic, microbiome and inflammation markers are potential mechanisms by which diet may alter disease trajectory. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Significance of Orlistat in management of dyslipidemia, systolic blood pressure and body mass index.

The current study intends to find out the efficacy of Orlistat in the management of hyperlipidemia, Systolic Blood Pressure (SBP) and Body Mass Index (BMI). This retrospective study has evaluated the lipid profiles of the patients, who have been using metformin therapy for Type 2 diabetes. The study has obtained data regarding the parameters like triglyceride, Total cholesterol (TC), LDL cholesterol, HDL cholesterol and LDL/HDL ratio, systolic blood pressure and Body Mass Index (BMI). Random distribution of patients was done into placebo and Orlistat groups. The placebo group received only metformin, and patients in the Orlistat group received Orlistat along with metformin. After 24 weeks, the follow-up study was done, and statistical analysis was conducted. The study found that the Orlistat group has significant improvement (p<0.05) more improvement in LDL cholesterol, HDL cholesterol, Total cholesterol, LDL/HDL Ratio and Triglycerides, while BMI and systolic blood pressure did not show a significant difference between placebo and Orlistat group. This study has concluded that Orlistat can be used for significant improvement in lipid profile. The study also found that Orlistat may not have a significant effect on reducing BMI and blood pressure without adequate lifestyle modification.

RS9939609 FTO gene variant modified weight loss and insulin resistance after a partial meal-replacement hypocaloric diet.

Some studies have demonstrated that the allele A of FTO rs9939609 is related to both higher waist circumference and body mass index. Subsequently, some designs related biochemical variables and body weight changes with this genetic variant. We decide to analyze the effects of rs9939609 genetic variant of FTO gene on metabolic parameters and weight loss secondary to partial meal replacements hypocaloric diets (pMRHDs) in obese subjects. This was a non-randomized, single-treatment study with a formula-diet in 44 obese subjects. The patients received nutritional education and a pMRHDs with two intakes of normocaloric hyperproteic formula during 12 weeks. Anthropometric parameters and biochemical profiles were measured at basal time and after 12 weeks. The variant of FTO gene rs9939609 was determined. Genotype distribution (n=44) was (16 TT (36.4%), 17 TA (38.6%) and 11 AA (25.0%)). After the pMRHD, body weight, body mass index (BMI), fat mass, waist circumference, serum leptin levels and systolic blood pressure improved in both genotypes without statistical differences in both branches. After dietary intervention with pMRHD, subjects with A allele showed a significant improvement in total cholesterol levels (TT vs. TA+AA) (-3.8±1.4 md/dL vs. -12.6±1.7 mg/dl: p=0.01), LDL-cholesterol (-0.2±1.5 md/dL vs. -10.5±1.9 mg/dl: p=0.02), insulin levels (-1.9±0.2 mU/L vs. -3.8±0.3 mU/L: p=0.02) and HOMA-IR (-0.6±0.2 units vs. -1.1±0.1 units: p=0.01). Our data suggest that the genetic variant (rs9939609) of FTO gene showed better improvement of LDL-cholesterol, insulin and HOMA-IR in subjects with A allele.

The effects of a lifestyle-focused text-messaging intervention on adherence to dietary guideline recommendations in patients with coronary heart disease: an analysis of the TEXT ME study

BackgroundA healthy diet is an important component of secondary prevention of coronary heart disease (CHD). The TEXT ME study was a randomised clinical trial of people with CHD that were randomised into standard care or a text-message programme in addition to standard care. This analysis aimed to: 1) assess the effects of the intervention onadherence to the dietary guideline recommendations; 2) assess the consistency of effect across sub-groups; and 3) assess whether adherence to the dietary guideline recommendations mediated the improvements in objective clinical outcomes.MethodsDietary data were collected using a self-report questionnaire to evaluate adherence to eight dietary guideline recommendations in Australia, including consumption of vegetables, fruits, fish, type of fat used for cooking and in spreads, takeaway food, salt and standard alcohol drinks. The primary outcome of this analysis was the proportion of patients adhering to ≥ 4 dietary guideline recommendations concomitantly and each recommendation was assessed individually as secondary outcomes. Data were analysed using log-binomial regression for categorical variables and analysis of covariance for continuous variables.ResultsAmong 710 patients, 54% were adhering to ≥ 4 dietary guideline recommendations (intervention 53% vs control 56%, p = 0.376) at baseline. At six months, the intervention group had a significantly higher proportion of patients adhering to ≥ 4 recommendations (314, 93%) compared to the control group (264, 75%, RR 1.23, 95% CI 1.15–1.31, p < 0.001). In addition, the intervention patients reported consuming higher amounts of vegetables, fruits, and fish per week; less takeaway foods per week; and greater salt intake control. The intervention had a similar effect in all sub-groups tested. There were significant mediational effects of the increase in adherence to the recommendations for the association between the intervention and LDL-cholesterol (p < 0.001) and body mass index (BMI) at six months follow-up (p = 0.005).ConclusionA lifestyle-focused text-message programme improved adherence to the dietary guideline recommendations, and specifically improved self-reported consumption of vegetables, fruits, fish, takeaway foods and salt intake. Importantly, these improvements partially mediated improvements in LDL-cholesterol and BMI. This simple and scalable text-messaging intervention could be used as a strategy to improve diet in people with CHD.Trial registrationAustralia and New Zealand Clinical Trials Registry ACTRN12611000161921. Registered on 10 February 2011.

Impact of switching to polypill based therapy by baseline potency of medication: Post-hoc analysis of the SPACE Collaboration dataset.

Fixed dose combinations of cardiovascular therapy ('polypills') have now been launched in several dozen countries. There is considerable clinical interest in the effects of switching to polypill-based care from typical current treatment regimens, especially if polypills contain components at sub-maximal dosage. The SPACE Collaboration includes three trials of polypill based care vs usual care in patients with established CVD or at high calculated risk. Individual patient data for 3140 trial participants were combined. Patients were categorized according to the potency of the statin and the number of BP lowering medications they were taking at baseline. Effects on adherence to anti-platelet medication, systolic blood pressure (SBP) and LDL cholesterol stratified by baseline potency of medication were determined using fixed effects models. Randomisation to the polypill group was associated with improved SBP at 12months, but this improvement varied according to baseline BP regimen: -3.3, -5.9, -2.5 and +1mmHg for patients taking 0, 1, 2 and 3+ BP lowering medications at baseline. For changes in LDL cholesterol at 12months, significant improvements in LDL cholesterol were seen for those taking no statin (-0.21mmol/L; 95% CI: -0.34 to -0.07), less potent statin (-0.16mmol/L; 95% CI: -0.29 to -0.04) and equipotent statins (-0.14mmol/L; 95% CI -0.26 to -0.02) at baseline. The adherence benefits of polypills tend to offset the loss of potency from use of individual components with lower dose potency, and to facilitate improvements in multiple risk factors.

PKCη deficiency improves lipid metabolism and atherosclerosis in apolipoprotein E-deficient mice.

Genomewide association studies have shown that a nonsynonymous single nucleotide polymorphism in PRKCH is associated with cerebral infarction and atherosclerosis-related complications. We examined the role of PKCη in lipid metabolism and atherosclerosis using apolipoprotein E-deficient (Apoe-/- ) mice. PKCη expression was augmented in the aortas of mice with atherosclerosis and exclusively detected in MOMA2-positive macrophages within atherosclerotic lesions. Prkch+/+ Apoe-/- and Prkch-/- Apoe-/- mice were fed a high-fat diet (HFD), and the dyslipidemia observed in Prkch+/+ Apoe-/- mice was improved in Prkch-/- Apoe-/- mice, with a particular reduction in serum LDL cholesterol and phospholipids. Liver steatosis, which developed in Prkch+/+ Apoe-/- mice, was improved in Prkch-/- Apoe-/- mice, but glucose tolerance, adipose tissue and body weight, and blood pressure were unchanged. Consistent with improvements in LDL cholesterol, atherosclerotic lesions were decreased in HFD-fed Prkch-/- Apoe-/- mice. Immunoreactivity against 3-nitrotyrosine in atherosclerotic lesions was dramatically decreased in Prkch-/- Apoe-/- mice, accompanied by decreased necrosis and apoptosis in the lesions. ARG2 mRNA and protein levels were significantly increased in Prkch-/- Apoe-/- macrophages. These data show that PKCη deficiency improves dyslipidemia and reduces susceptibility to atherosclerosis in Apoe-/- mice, showing that PKCη plays a role in atherosclerosis development.

Determinants of Bezafibrate-induced Improvements in LDL Cholesterol in Dyslipidemic Patients with Diabetes.

Our previous "J-BENEFIT (Japan BEzafibrate cliNical EFfectIveness and Tolerability)" study demonstrated that bezafibrate improves blood lipid profiles and glucose control in dyslipidemic patients with diabetes. However, bezafibrate did not significantly improve low-density lipoprotein cholesterol (LDL-C), although some patients showed decreases while others showed increases in the LDL-C levels. Therefore, a subgroup analysis of the J-BENEFIT study was conducted to identify factors influencing the bezafibrate-induced changes in the LDL-C levels. Of the 3,316 patients in the J-BENEFIT study, 2,116 not treated with other lipid-lowering drugs were enrolled in the current study, and the effects of 24-week treatment with bezafibrate on the LDL-C levels were analyzed. A reduction in the LDL-C level of ≥ 25% occurred in 253 patients, and a logistic-regression analysis was used to identify factors associated with this improvement. Among the 2,116 overall patients, bezafibrate treatment significantly increased the LDL-C levels from 123.9±36.7 to 125.7±31.3 mg/dL. The subanalysis showed that the treatment responses varied according to the baseline LDL-C level, with significant decreases in the ≥ 160 and ≥ 140-＜160 mg/dL groups, no significant decrease in the ≥ 120-＜140 mg/dL group and a significant increase in the ＜120 mg/dL group. A multivariate logistic-regression analysis of the data for the patients with an LDL-C of ≥ 25% identified a female sex, the use of anti-hypertensive and hypoglycemic agents and a high baseline LDL-C level to be significant determinants of the LDL-C response to bezafibrate. Our results showed that treatment with bezafibrate improves the LDL-C levels and lipid profiles in dyslipidemic diabetic patients, especially women, subjects co-treated with anti-hypertensive or hypoglycemic agents and those with high baseline LDL-C levels.

Human Clinical Studies of Tea Polyphenols in Allergy or Life Style-related Diseases

Many previous epidemiological studies have revealed that green tea or green tea catechins contributed to the preveintion of lifestyle-related diseases. Several cohort studies on the relationship between green tea consumption and cardiovascular disease (CVD) risk/type 2 diabetes mellitus risk have been conducted. The results showed that green tea consumption (5 or more cups/day) was inversely associated with mortality from CVD and all causes. Within CVD mortality, the strongest inverse association was observed for stroke mortality. Furthermore, consumption of green tea, coffee, and total caffeine was associated with a reduced risk for type 2 diabetes. On the other hand, the analysis of randomized clinical trial (RCT) studies showed that the administration of green tea beverages or extracts resulted in significant reductions in serum total cholesterol and LDL-cholesterol concentrations, but had no apparent effect on HDL-cholesterol. Green tea reduced fasting blood glucose levels in a small intervention trial, although no improvements in HbA1c levels were seen. Continuous intake of green tea containing catechins and caffeine (5 or more cups per day) may be beneficial for body weight management, vascular disease risk reduction via LDL-cholesterol improvement, and type 2 diabetes risk reduction through the lowering of fasting blood glucose levels. Epigallocatechin-3-O-(3-O-methyl) gallate (EGCG3"Me) isolated from cv. "Benifuuki" green tea has been shown to strongly inhibit mast cell activation and histamine release after FcepsilonRI cross-linking through the suppression of tyrosine phosphorylation (Lyn) of cellular protein kinase, and the suppression of myosin light chain phosphorylation and high-affinity IgE receptor expression via the binding to 67 kDa laminin receptors. A double-blind clinical study on subjects with Japanese cedar pollinosis was carried out. At the eleventh week after starting intake, which was coincident with the most severe period of cedar pollen-scattering, symptoms such as nose blowing and eye itching were significantly relieved in the Benifuuki group compared with the placebo group. Six weeks of intake of Benifuuki green tea containing O-methylated catechins was useful for reducing some of the symptoms derived from Japanese cedar pollinosis, and did not affect any of the normal immune responses in the subjects with Japanese cedar pollinosis. Based on an investigation into the effects of the cultivars, tea seasons of crops and manufacturing methods, it was concluded that green or semi-fermented tea made from fully-matured Benifuuki in the second crop season should be consumed.

The impact of a disease management program (COACH) on the attainment of better cardiovascular risk control in dyslipidaemic patients at primary care centres (The DISSEMINATE Study): a randomised controlled trial

BackgroundTo evaluate the efficacy of Counselling and Advisory Care for Health (COACH) programme in managing dyslipidaemia among primary care practices in Malaysia. This open-label, parallel, randomised controlled trial compared the COACH programme delivered by primary care physicians alone (PCP arm) and primary care physicians assisted by nurse educators (PCP-NE arm).MethodsThis was a multi-centre, open label, randomised trial of a disease management programme (COACH) among dyslipidaemic patients in 21 Malaysia primary care practices. The participating centres enrolled 297 treatment naïve subjects who had the primary diagnosis of dyslipidaemia; 149 were randomised to the COACH programme delivered by primary care physicians assisted by nurse educators (PCP-NE) and 148 to care provided by primary care physicians (PCP) alone. The primary efficacy endpoint was the mean percentage change from baseline LDL-C at week 24 between the 2 study arms. Secondary endpoints included mean percentage change from baseline of lipid profile (TC, LDL-C, HDL-C, TG, TC: HDL ratio), Framingham Cardiovascular Health Risk Score and absolute risk change from baseline in blood pressure parameters at week 24. The study also assessed the sustainability of programme efficacy at week 36.ResultsBoth study arms demonstrated improvement in LDL-C from baseline. The least squares (LS) mean change from baseline LDL-C were −30.09% and −27.54% for PCP-NE and PCP respectively. The difference in mean change between groups was 2.55% (p=0.288), with a greater change seen in the PCP-NE arm. Similar observations were made between the study groups in relation to total cholesterol change at week 24. Significant difference in percentage change from baseline of HDL-C were observed between the PCP-NE and PCP groups, 3.01%, 95% CI 0.12-5.90, p=0.041, at week 24. There was no significant difference in lipid outcomes between 2 study groups at week 36 (12 weeks after the programme had ended).ConclusionPatients who received coaching and advice from primary care physicians (with or without the assistance by nurse educators) showed improvement in LDL-cholesterol. Disease management services delivered by PCP-NE demonstrated a trend towards add-on improvements in cholesterol control compared to care delivered by physicians alone; however, the improvements were not maintained when the services were withdrawn.Trial registrationNational Medical Research Registration (NMRR) Number: NMRR-08-287-1442Trial Registration Number (ClinicalTrials.gov Identifier): NCT00708370

Is the process of delivery of an individually tailored lifestyle intervention associated with improvements in LDL cholesterol and multiple lifestyle behaviours in people with Familial Hypercholesterolemia?

BackgroundMore insight in the association between reach, dose and fidelity of intervention components and effects is needed. In the current study, we aimed to evaluate reach, dose and fidelity of an individually tailored lifestyle intervention in people with Familial Hypercholesterolemia (FH) and the association between intervention dose and changes in LDL-Cholesterol (LDL-C), and multiple lifestyle behaviours at 12-months follow-up.MethodsParticipants (n = 181) randomly allocated to the intervention group received the PRO-FIT intervention consisting of computer-tailored lifestyle advice (PRO-FIT*advice) and counselling (face-to-face and telephone booster calls) using Motivational Interviewing (MI). According to a process evaluation plan, intervention reach, dose delivered and received, and MI fidelity were assessed using the recruitment database, website/counselling logs and the Motivational Interviewing Treatment Integrity (MITI 3.1.1.) code. Regression analyses were conducted to explore differences between participant and non-participant characteristics, and the association between intervention dose and change in LDL-C, and multiple lifestyle behaviours.ResultsA 34% (n = 181) representative proportion of the intended intervention group was reached during the recruitment phase; participants did not differ from non-participants (n = 623) on age, gender and LDL-C levels. Of the participants, 95% received a PRO-FIT*advice log on account, of which 49% actually logged on and completed at least one advice module. Nearly all participants received a face-to-face counselling session and on average, 4.2 telephone booster calls were delivered. None of the face-to-face sessions were implemented according to MI guidelines. Overall, weak non-significant positive associations were found between intervention dose and LDL-C and lifestyle behaviours.ConclusionsImplementation of the PRO-FIT intervention in practice appears feasible, particularly PRO-FIT*advice, since it can be relative easily implemented with a high dose delivered. However, only less than half of the intervention group received the complete intervention-package as intended. Strategies to let participants optimally engage in using web-based computer-tailored interventions like PRO-FIT*advice are needed. Further, more emphasis should be put on more extensive MI training and monitoring/supervision.Trial registrationNTR1899 at ww.trialregister.nl.

Effects of soy isoflavones on atherosclerosis: potential mechanisms

It has long been recognized that coronary heart disease rates are lower in Japan, where soy consumption is common, than in Western countries. In experimental studies, atherosclerosis was reduced in animals fed diets containing soy protein compared with those fed diets with animal protein. Recently, several lines of evidence have suggested that the components of soy protein that lower lipid concentrations are extractable by alcohol (eg, the isoflavones genistein and daidzein). We recently evaluated the relative effect of the soy protein versus the alcohol-extractable components of soy on cardiovascular disease and its risk factors. Young male and female cynomolgus monkeys were fed diets that contained either 1) casein-lactalbumin as the source of protein (casein), 2) soy protein isolate from which the isoflavones were alcohol extracted (SPI-), or 3) isoflavoneintact soy protein (SPI+). The SPI+ group had significant improvements in LDL cholesterol and HDL cholesterol. Only HDL cholesterol was significantly improved in the SPI-group males compared with the casein group. The casein group had the most atherosclerosis, the SPI+ group had the least, and the SPI-group was intermediate but did not differ significantly from the casein group. Potential mechanisms by which soy isoflavones might prevent atherosclerosis include a beneficial effect on plasma lipid concentrations, antioxidant effects, antiproliferative and antimigratory effects on smooth muscle cells, effects on thrombus formation, and maintenance of normal vascular reactivity.