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Effect of a Dietary Portfolio of Cholesterol-Lowering Foods Given at 2 Levels of Intensity of Dietary Advice on Serum Lipids in Hyperlipidemia: A Randomized Controlled Trial Cardiology JAMA JAMA Network CHD indicates coronary heart disease; LDL-C, low-density lipoprotein cholesterol.
Absolute Values of LDL-C and TC:HDL-C Ratio and Percentage Changes in LDL-C and TC:HDL-C Ratio From Baseline in the Control, Intensive Dietary, and Routine Dietary Portfolios LDL-C indicates low-density lipoprotein cholesterol; TC, total cholesterol; HDL-C, high-density lipoprotein cholesterol.
Error bars indicate SE.
Blood Lipids, Blood Pressure, and Plant Sterols in the Control and Portfolio Diets at Weeks 0 and 24 and the Between-Treatment Differences Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults.
Executive Summary of The Third Report of The National Cholesterol Education Program NCEP Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults Adult Panel III.
Management of hyperlipidaemia: guidelines of the British Hyperlipidaemia Association.
Dietary treatments for obesity are ineffective.
Intensive lifestyle changes for reversal of coronary heart disease.
Effect of dietary sodium intake on blood lipids: results from the DASH-sodium trial.
Weight loss with a low-carbohydrate, Mediterranean, or перейти diet.
N Engl J Med.
Implications of recent clinical trials for the National Cholesterol Education Program Видеокамера JVC GR-FX11EE Treatment Panel III guidelines.
Plant sterols, health claims and strategies to reduce cardiovascular disease risk.
J Am Coll Nutr.
Effects of a dietary portfolio of cholesterol-lowering foods vs lovastatin on serum lipids and C-reactive protein.
Direct comparison of a dietary portfolio of cholesterol-lowering foods with a statin in hypercholesterolemic participants.
Am J Clin Nutr.
Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge.
Measurement of proteins with the Behring Nephelometer.
J Clin Chem Clin Biochem.
Efficacy of plant sterols is not influenced by dietary cholesterol intake in hypercholesterolemic individuals.
An updated coronary risk profile.
A statement for health professionals.
Efficacy and safety of statin treatment for cardiovascular disease: a network meta-analysis of 170,255 patients from 76 randomized trials.
Frequent nut consumption and risk of coronary heart disease in women: prospective cohort study.
Nuts and their bioactive constituents: effects on serum lipids and other factors that affect disease risk.
Am J Clin Nutr.
Long-term intake of dietary fiber and decreased risk of coronary heart disease among women.
A prospective study of dietary fiber intake and risk of cardiovascular disease among women.
J Am Coll Cardiol.
Low-carbohydrate-diet score and the risk of coronary heart disease in women.
N Engl J Med.
Soy food consumption is associated with lower risk of coronary heart disease in Chinese women.
Cholesterol-lowering effects of psyllium intake adjunctive to diet Dr.Koffer 25801/PELTRO in men and women with hypercholesterolemia: meta-analysis of 8 controlled trials.
Am J Clin Nutr.
Cholesterol-lowering effects of dietary fiber: a meta-analysis.
Am J Clin Nutr.
Efficacy and safety of plant stanols and sterols in the management of blood cholesterol levels.
Soy protein reduces serum cholesterol by both intrinsic and food displacement mechanisms.
Meta-analysis of the effects of soy protein intake on serum lipids.
N Engl J Med.
The impact посмотреть еще dietary changes and dietary supplements on lipid profile.
Nut consumption and blood lipid levels: a pooled analysis of 25 intervention trials.
A controlled clinical trial of a diet high in unsaturated fat in preventing complications of atherosclerosis.
Effect of cholesterol-lowering diet on mortality from coronary heart-disease and other causes: a twelve-year clinical trial in men and women.
Effect of cholesterol-lowering diet on mortality from coronary heart disease and other causes.
Comparison of weight-loss diets with different compositions of fat, protein, and carbohydrates.
N Engl J Med.
Effects of protein, monounsaturated fat, and carbohydrate intake on blood pressure and serum lipids: results of the OmniHeart randomized trial.
Comparison of the Atkins, Ornish, Weight Watchers, and Zone diets for weight loss and heart disease risk reduction: a randomized trial.
The glycemic index: physiological mechanisms relating to obesity, diabetes, and cardiovascular disease.
Effect of a Dietary Portfolio of Cholesterol-Lowering Foods Given at 2 Levels of Intensity of Dietary Advice on Serum Lipids in Hyperlipidemia : A Randomized Controlled Trial.
Abstract Context Combining foods with recognized cholesterol-lowering properties dietary portfolio has proven highly effective in lowering serum cholesterol under metabolically controlled conditions.
Objective To assess the effect of a dietary portfolio administered at 2 levels of intensity on percentage change in low-density lipoprotein cholesterol LDL-C among participants following self-selected diets.
Design, Setting, and Participants A parallel-design study of 351 participants with hyperlipidemia from 4 participating academic centers across Canada Quebec City, Toronto, Winnipeg, and Vancouver randomized between June 25, 2007, and February 19, 2009, to 1 of 3 treatments lasting 6 months.
Routine dietary portfolio involved 2 clinic visits over 6 months and intensive dietary portfolio involved 7 clinic visits over 6 months.
Main Outcome Measures Percentage change in serum LDL-C.
As a result, alternative dietary paradigms have been proposed - and efforts have been made to enhance the ability of conventional dietary therapy to reduce serum cholesterol through the inclusion of specific foods or food components with known cholesterol-lowering properties,singly or in combination dietary portfolio.
Use of these cholesterol-lowering dietary components in combination in short-term studies with all food provided has been shown to reduce serum low-density lipoprotein cholesterol LDL-C to a similar extent as first-generation statins.
We therefore undertook a multicenter trial to determine whether advice to eat a dietary portfolio consisting of foods recognized by the US Food and Drug Administration FDA as associated with lowering serum cholesterol achieved significantly greater percentage decreases in LDL-C compared with a control diet at 6-month follow-up.
The control diet emphasized high fiber and whole grains but lacked portfolio components.
To increase the relevance of the study for routine clinical application, the advice was given at 2 levels of intensity, either as a routine dietary portfolio 2 clinic visits of 40- to 60-minute sessions or an intensive dietary portfolio 7 clinic visits of 40- to 60-minute sessions.
Participants Three hundred fifty-one participants with hyperlipidemia 137 men and 214 postmenopausal women were randomized after recruitment through advertisement by 4 participating centers across Canada Quebec City, Toronto, Winnipeg, and Vancouver.
Study Protocol Recruitment was achieved by advertising in newspapers, subway cars, lipid clinics, and family practice offices, and randomization took place between June 25, 2007, and February 19, 2009.
The blocks were created by a statistician E.
Neither the dietitian nor the participants could be blinded to treatment; however, the statistician, investigators, and laboratory staff who analyzed the samples were unaware of participant allocation.
Treatments were coded as 1, 2, and 3.
Participants were randomized to a узнать больше study of dietary advice to take either a therapeutic low-fat diet control or dietary portfolio of cholesterol-lowering foods with either 2 visits routine or 7 visits intensive during a 6-month period.
Study visits occurred at baseline week 0 and at 3 and 6 months for the control and routine dietary portfolio interventions, and baseline, 2 weeks, and subsequently at monthly follow-up for the intensive dietary portfolio intervention.
At each study visit, the preceding 7-day diet histories were assessed by the dietitian and discussed with the participant.
Body weight was measured and a fasting blood sample obtained.
At each visit, blood pressure was measured 3 times in the nondominant arm using a digital blood pressure monitor Omron HEM-907XL, Omron Healthcare Inc, Vernon Hills, Illinois.
The study was approved by the ethics committees of St Michael's Hospital and the universities of Toronto, Manitoba, British Columbia, and Laval, and the National Health Products Directorate, Health Canada.
Informed was obtained in writing from the participants.
Diets shows diets for participants in each study group before enrollment.
During the 6-month study period, dietitians counseled participants to follow weight-maintaining vegetarian diets from foods available in supermarkets and health food stores.
Counseling periods were 1-hour duration for the first visit and 30 to 40 minutes at subsequent visits.
For participants in the dietary portfolio interventions, dietitians focused on incorporating study foods into the participants' regular diets using their 7-day food diaries as templates.
Participants were provided with a 7-day study food checklist and an посетить страницу study booklet.
The goal of the dietary portfolio was to provide 0.
Consumption of peas, beans, and lentils was also encouraged.
This dietary portfolio has been described in detail previously.
The control dietary advice focused on low-fat dairy and whole grain cereals together with fruit and vegetables and avoidance of the specific portfolio components.
Participants were provided with measuring cups and measuring spoons to assist in portion control.
Serum lipid standards Solomon Park Research Laboratories, Kirkland, Washington were used to quality control the lipid analyses at the 4 collaborating sites.
The mean interbatch coefficients of variation at each site were all less than 3.
Alick Little Lipid Laboratory at St Michael's Hospital, Toronto, Ontario, Canada, for apolipoprotein A-l and B by nephelometry intra-assay coefficients of variation, 2.
Plant sterols in serum were measured in the sterol laboratory of the Richardson Center by gas chromatography with flame ionization detectors 6890 GC, Agilent Technologies, Palo Alto, California.
Diets were analyzed using a program based on US Department https://booksarchive.ru/100/baldinini-bld-1721-103.html Agriculture data ESHA Food Processor SQL version 10.
Adherence with the 4 portfolio components was estimated from the 7-day food records by expressing the recorded intake for each of the 4 main components as 25%.
The sum of the 4 components if consumed as prescribed would equal 100% adherence.
Statistical Analysis A intention-to-treat analysis was undertaken on the 345 participants to whom randomization had been revealed.
Missing data were multiple imputed using PROC MIXED and MIANALYZE in SAS version 9.
Multiple imputation assumes the values imputed are randomly sampled from the distribution of true unobserved missing values.
PROC MIXED was used to determine the significance of the change in outcome from week 0 to week 24 as the response variable with treatment, sex, and treatment × sex as main effects and baseline as a covariate.
A Tukey adjustment was used for multiple comparisons.
Percentage change in LDL-C adjusted for sex was the primary outcome.
In addition, the 10-year Framingham CHD risk score was calculated for this predominantly white cohort.
Pearson correlation was used to calculate the correlation coefficient between dietary adherence and percentage change in LDL-C.
One hundred ten participants were required treatment group.
Results The study was conducted between 2007 and 2009, and randomization took place between June 25, 2007, and February 19, 2009.
The baseline characteristics of the participants were similar for all 3 treatments, with the exception of the ratio of men to women, which was higher on the intensive portfolio than on the other 2 treatments.
No participants were taking medications known to influence serum lipids, except 31 women and 4 men придёте ROBITON LGC2600 (ICR 18650 B4) без защиты SR1, в упак 100 шт Аккумулятор думаю were all receiving stable doses of thyroxine and 12 women who were receiving estrogen therapy.
Fifty-one participants 14% had been taking statins before the study commenced and had discontinued taking the medications at least 2 weeks before the study.
The mean overall adherence for all participants to the intensive dietary portfolio was 46.
Blood Lipids, Apolipoproteins, and CRP No differences were observed between the 3 treatment groups in baseline blood measurements.
The apolipoproteins reflected the lipid and lipoprotein changes.
No significant differences were observed between treatments in CRP.
No treatment differences in response were observed between men and women.
Blood Pressure The intensive dietary portfolio led to a nonsignificant reduction in systolic blood pressure of 2.
Calculated CHD Risk The routine dietary portfolio reduced the calculated 10-year CHD risk by 10.
Adverse Перейти на источник Events There were no serious adverse events or events that required hospitalization.
None of the events were directly linked to the study intervention, except for 1 man who had recurrent flushing and itching at the back of the neck and was found to have positive skin test for soy in the routine dietary portfolio, and 1 woman with a rash and positive skin test for soy and almonds in the intensive dietary portfolio.
Comment Our data demonstrate the cholesterol-lowering potential of a dietary portfolio intervention that counsels participants to increase consumption of cholesterol-lowering foods denoted by the US FDA to have heart health benefit and that have also been recommended in national guidelines to enhance the effectiveness of cholesterol-lowering therapeutic diets.
The reductions in LDL-C in the dietary portfolio intervention were approximately half those observed with early statin trials that were associated with 20% reductions in CHD mortality.
Similar associations were identified for soy protein consumption in the Shanghai cohort.
Further study is needed to determine whether cholesterol reduction using these portfolio components is associated with lower rates of CHD events.
The specific food components used in the portfolio have well-established cholesterol-lowering properties and are recognized by the US FDA as justifying a heart health claim.
Review articles and meta-analyses have confirmed LDL-C benefits for viscous fibers,plant sterols,soy protein, - and nuts.
On the basis of the reported intake of portfolio components, one might expect a 4% LDL-C reduction from viscous fiber, 2% each from nuts and soy, and 5% from plant sterols, resulting in 13% LDL-C reduction.
A reduction of a similar magnitude 13%-14% was observed in our study.
This is the first study to our knowledge to assess the effect of frequency of visit on dropout rate, adherence, and outcome.
Although a small reduction was observed in the dropout rate by increasing the frequency of visits from 2 to 7 during the 6-month period, no advantage was observed in terms of dietary adherence or the percentage LDL-C reduction at 24 weeks.
More frequent clinic attendance therefore appears to be unnecessary in achieving a significant percentage reduction in LDL-C.
The near maximal effectiveness of only 2 clinic visits enhances the suitability of this dietary approach for clinical application.
The study had limitations.
First, the intervention was complex.
Second, colinearity between the different dietary components did not permit attribution of the lipid-lowering effect to specific components of the intervention.
Third, the study was not metabolically controlled in terms of providing all food to the participants.
However, our goal was to assess the effect of dietary advice in real-world conditions.
Studies of longer duration in Технические условия 10.02.02.789-09-89 provision of specific diets possible have relied on workplace or institutional environments.
This attrition rate is common to dietary studies provided at these levels of intensity.
The generalizability of this clinical trial to higher-risk, more overweight, or obese patient populations is unknown.
The study advantages include its multicenter nature with centers from across the continent.
Participants who joined the study were already consuming an acceptable background diet low in saturated fat and cholesterol to provide a fairer illustration of the type of patients for whom standard dietary advice has failed to achieve therapeutic targets.
This approach may underestimate the effectiveness of the diet when applied to those individuals who are not already following therapeutic diets.
However, it is also possible that participants in this study are better able to adhere to healthy diets than those who chose not to participate.
Many of the foods have other attributes, including lowering the glycemic index, which may aid in reducing disease risk for CHD, diabetes, and obesity.
In addition, the dietary portfolio treatments lowered LDL-C without also lowering HDL-C.
In conclusion, this study indicated the potential value of using recognized cholesterol-lowering foods in combination.
We believe this approach has clinical application.
A meaningful 13% LDL-C reduction can be obtained after only 2 clinic visits of approximately 60- and 40-minute sessions.
The limited 3% LDL-C reduction observed in the conventional diet is likely to reflect the adequacy of the baseline diet and therefore suggests that larger absolute reductions in LDL-C may be observed when the dietary portfolio is prescribed to patients with diets more reflective of the general population.
Article Information Corresponding Author: David J.
Jenkins, MD, Clinical Nutrition and Risk Factor Modification Center, St Michael's Hospital, 61 Queen St E, Toronto, ON 2T2, Canada.
Author Contributions: Читать статью Jenkins had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Jenkins, Jones, Lamarche, Kendall, Cermakova.
Acquisition of data: Jones, Lamarche, Kendall, Faulkner, Cermakova, Gigleux, Ramprasath, Ireland, Patel, Bashyam, Collier, Hoshizaki, Connelly, Frohlich.
Analysis and interpretation of data: Jenkins, Jones, Lamarche, Kendall, Faulkner, Ramprasath, de Souza, Srichaikul, Abdulnour, Josse, Leiter, Connelly, Frohlich.
Drafting of the manuscript: Jenkins.
Critical revision of the manuscript for important intellectual content: Jenkins, Jones, Lamarche, Kendall, Faulkner, Cermakova, Gigleux, Ramprasath, de Souza, Ireland, Patel, Srichaikul, Abdulnour, Bashyam, Collier, Hoshizaki, Josse, Leiter, Connelly, Frohlich.
Statistical analysis: de Souza, Abdulnour.
Obtained funding: Jenkins, Jones, Lamarche, Kendall, Frohlich.
Administrative, technical, or material support: Jones, Kendall, Faulkner, Cermakova, Gigleux, Ramprasath, Ireland, Patel, Srichaikul, Abdulnour, Bashyam, Collier, Hoshizaki, Josse, Leiter, Connelly, Frohlich.
Study supervision: Jenkins, Jones, Lamarche, Kendall, Faulkner, Cermakova, Gigleux, Ramprasath, Connelly, Frohlich.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest.
Dr Jenkins' wife is a director of Glycemic Index Laboratories, Toronto, Ontario, Canada, and his sister, Caroline Brydson, contributed to the diet booklet used in the study, which may in the future be expanded to book form for the general public.
Dr Jones reported receiving grants from the Canadian Institutes of Health Research CIHRCanada Research Chair Endowment CRCE of the Federal Government of Canada, Advanced Foods and Materials Network AFM NetDanone, Enzymotec, and Unilever.
Dr Jones also serves as president of Nutritional Fundamentals for Health Inc, which markets plant sterols among other nutraceuticals.
Dr Lamarche reported receiving grants from CIHR and AFM Net, being a consultant and on speakers bureaus for Danone, and receiving royalties from Atrium Innovations.
Dr Kendall reported being on speakers bureaus for Almond Board of California, Solae, and Unilever; and receiving research grants from CIHR, Unilever, Solae, Loblaw Brands Ltd, International Tree Nut Council, and Almond Board of California.
Dr Faulkner reported receiving grants from CRCE of the Federal Government of Canada, CIHR, AFM Net, Loblaw Brands Ltd, Unilever, and Solae.
Ms Cermakova reported receiving grants from CRCE of the Federal Government of Canada, CIHR, AFM Net, Loblaw Brands Ltd, Unilever, Solae, and Viterra Food Processing-Oat and Specialty Grain Milling.
Dr Ramprasath reported receiving grants from CRCE of the Federal Government of Canada, CIHR, AFM Net, Loblaw Brands Ltd, Solae, and Unilever.
Dr de Souza reported receiving grants from Coca-Cola, Calorie Control Council, and CIHR.
Mr Ireland reported receiving grants from CRCE of the Federal Government of Canada, CIHR, AFM Net, Loblaw Brands Ltd, Solae, and Unilever.
Ms Patel reported receiving grants from CRCE of the Federal Government of Canada, CIHR, AFM Net, Loblaw Brands Ltd, Solae, and Unilever.
Dr Bashyam reported receiving grants from CIHR, Наконечник втулочный красный изолированный DIN 46228 10 мм² Klauke KLK47612 100 шт. of the Federal Government of Canada, AFM Net, Loblaw Brands Ltd, Solae, and Unilever.
Ms Hoshizaki reported receiving grants from CRCE of the Federal Government of Canada, CIHR, AFM Net, Loblaw Brands Ltd, Unilever, and Solae.
No other authors reported any financial disclosures.
Unilever Research and Development provided the donation of margarines used in the study and Can-Oat Milling, a division of Viterra Inc Portage La Prairie, Manitoba, Canadaprovided the generous donation of HiFi medium oat bran used for the study breads and funding for freezer acquisition.
St Michael's Hospital Foundation provided funding for the production of the study booklet.
Role of the Sponsors: The primary funder of the study was the CIHR.
AFM Net, a government- funded Center of Excellence, and the industrial sponsors, Loblaw Brands Ltd, Solae, and Unilever, provided supplementary funding but played no role in the design and conduct of the study, in the collection, management, analysis, or interpretation of the data, or in the preparation, review, or approval of the manuscript.
Additional Contributions: Edward Всей How to Survive Summer Camp очень, BSc BSH Group of Companies Canada LTD, Toronto, Ontario, Canada was responsible for the power calculation in the original grant and for the generation of the randomization blocks.
His work was funded by grants to the University of Toronto by Loblaw Brands Ltd and the Almond Board of California.
Eyssen, PhD Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canadaprovided help with the original grant, especially with the statistical section.
No compensation was received for her contribution.
We thank the academic and private family practice units at all participating centers for their help in participant recruitment and the participants for their attention to detail, which made this study possible.
Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults.
Executive Summary of The Third Report of The National Cholesterol Education Program NCEP Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults Adult Treatment Panel III.
Management of hyperlipidaemia: guidelines of the British Hyperlipidaemia Association.
Dietary treatments for obesity are ineffective.
Intensive как сообщается здесь changes for reversal of coronary heart disease.
Effect of dietary sodium intake on blood lipids: results from the DASH-sodium trial.
Weight loss with a low-carbohydrate, Mediterranean, or low-fat diet.
N Engl J Med.
Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines.
Plant sterols, health claims and strategies to reduce cardiovascular disease risk.
J Am Coll Nutr.
Effects of a dietary portfolio of cholesterol-lowering foods Вентилятор накладной MMotors JSC LV 100 бочка (12V), (для бань, хамам) lovastatin on serum lipids and C-reactive protein.
Direct comparison of a dietary portfolio of cholesterol-lowering foods with a statin in hypercholesterolemic participants.
Am J Clin Nutr.
Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge.
Measurement of proteins with the Behring Nephelometer.
J Clin Chem Clin Biochem.
Efficacy of plant sterols is not influenced by dietary cholesterol intake in hypercholesterolemic individuals.
An updated coronary risk profile.
A statement for health professionals.
Efficacy and safety of statin treatment for cardiovascular disease: a network meta-analysis of 170,255 patients from 76 randomized trials.
Frequent nut consumption and risk of coronary heart disease in women: prospective cohort study.
Nuts and their bioactive constituents: effects on serum lipids and other factors that affect disease risk.
Am J Clin Nutr.
Long-term intake of dietary fiber and decreased risk of coronary heart disease among women.
A prospective study of dietary fiber intake and risk of cardiovascular disease among women.
J Am Coll Cardiol.
Low-carbohydrate-diet score and the risk of coronary heart disease in women.
N Engl J Med.
Soy food consumption is associated with lower risk of coronary heart disease in Chinese women.
Cholesterol-lowering effects of psyllium intake adjunctive to diet therapy in men and women with hypercholesterolemia: meta-analysis of 8 controlled trials.
Am J Clin Nutr.
Cholesterol-lowering effects of dietary fiber: a meta-analysis.
Am J Clin Nutr.
Efficacy and safety of plant stanols and sterols in the management of blood cholesterol levels.
Soy protein reduces serum cholesterol by both intrinsic and food displacement mechanisms.
Meta-analysis of the effects of soy protein intake on serum lipids.
N Engl J Med.
The impact of dietary changes and dietary supplements on lipid profile.
Nut consumption and blood lipid levels: a pooled analysis of 25 intervention trials.
A controlled clinical trial of a diet high in unsaturated fat in preventing complications of atherosclerosis.
Effect of cholesterol-lowering diet on mortality from coronary heart-disease and other causes: a clinical trial in men and women.
Effect of cholesterol-lowering diet on mortality from coronary heart disease and other causes.
Comparison of weight-loss diets with different compositions of fat, protein, and carbohydrates.
N Engl J Med.
Effects of protein, monounsaturated fat, and carbohydrate intake on blood pressure and serum lipids: results of the OmniHeart randomized trial.
Comparison of the Atkins, Ornish, Weight Watchers, and Zone diets for weight loss and heart disease risk reduction: a randomized trial.
The glycemic index: physiological mechanisms relating to obesity, diabetes, and cardiovascular disease.
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