Participants will receive advice on a therapeutic diet appropriate for hypercholesterolemia (ie <7% of energy from saturated fat, <200mg/d cholesterol) PLUS the combination of viscous fibres, soy protein, plant sterols and nuts, 5% extra monounsaturated fat, and selection of low glycemic index foods and be instructed on a standardized physical activity/exercise component supervised by kinesiologists.

Participants will receive advice to follow a DASH-like diet of whole grains, and low-fat dairy products with fruits and vegetables and a be instructed on the Laval exercise program—a standardized physical activity/exercise component supervised by trained kinesiologists (exercise physiologists).

Participants will receive advice that will conform to the current therapeutic diet appropriate for hypercholesterolemia (ie <7% of energy from saturated fat, <200mg/d cholesterol) PLUS the combination of viscous fibres, soy protein, plant sterols and nuts, 5% extra monounsaturated fat, and selection of low glycemic index foods and will be provided with a copy of Health Canada Physical Activity Guidelines with advice to increase physical activity.

Participants will receive advice to follow a DASH-like diet of whole grains, and low-fat dairy products with fruits and vegetables and will be provided with a copy of Health Canada Physical Activity Guidelines with advice to increase physical activity.

Cardiovascular Diseases

Hypercholesterolemia

Type 2 Diabetes

Metabolic Syndrome

Diet: Foods will contribute 9 g/1000 kcal viscous fibre as β-glucan (oats, barley and oat bran breads) and psyllium (cereal), 1 g plant sterol/1000 kcal diet (in sterol margarine), 22.5 g soy protein/1000 kcal (soy burgers and other soy meat analogues, soy milks, yogurts and cheese) and 22.5 g nuts/1000 kcal and increased MUFA (as olive and canola oils, avocados, nuts etc.). The glycemic index will be reduced from 83 to 70 GI units (bread scale).
Exercise: A program encouraging 150 minutes of exercise, based on the Quebec Heart and Lung Institute exercise program. A short submaximal treadmill test will be used to assess cardiorespiratory fitness. A kinesiologist will work with participants using behavioral strategies to achieve the target of 150 min/week of physical activity or exercise in 3 or 5 sessions weekly (vigorous, moderate or mild depending on goals and tolerance). The target goal will be at least 10,000 steps daily.

Portfolio diet and structured exercise

Diet: Participants will be encouraged to follow a diet of whole grain foods (brown rice, whole wheat breads, muffins and breakfast cereals), reduce meat consumption, choose low fat dairy foods and a control margarine.
Exercise: A physical activity/exercise program encouraging 150 minutes of exercise, based on the exercise program developed at the Quebec Heart and Lung Institute. A short submaximal treadmill test will be used to assess cardiorespiratory fitness. A kinesiologist will work with participants using behavioral strategies to develop and support a plan that aims to achieve the target of 150 min/week of physical activity or exercise in 3 or 5 sessions weekly (vigorous, moderate or mild depending of goals and tolerance) in keeping with maximum achievable goals of participants. The target goal will be at least 10,000 steps daily recorded on their pedometers.

DASH-like diet and structured exercise

Diet: Foods on the dietary portfolio plan will contribute 9 g/1000 kcal viscous fibre as β-glucan (oats, barley and oat bran breads) and psyllium (cereal), 1 g plant sterol/1000 kcal diet (in sterol margarine), 22.5 g soy protein/1000 kcal (soy burgers and other soy meat analogues, soy milks, yogurts and cheese) and 22.5 g peanuts or equivalent of tree nuts/1000 kcal (Table 1A) and increased MUFA (as olive and canola oils, avocados, nuts etc.). The glycemic index will be reduced from 83 to 70 GI units (bread scale).
Exercise: Participants in this group will receive standard of care for individuals being seen by a general practitioner. They will be advised to achieve the current recommended targets for daily physical activity and educational material published by Health Canada (Canada's Physical Activity Guide, Health Canada). They will undergo treadmill tests at the start and end of each 1 year period. They will not receive the more frequent, targeted visits with a kinesiologist.

Portfolio diet and routine exercise

Diet: Participants will be encouraged to follow a diet of whole grain foods (brown rice, whole wheat breads, muffins and breakfast cereals), reduce meat consumption, choose low fat dairy foods and a control margarine.
Exercise: Participants in this group will receive standard of care for individuals being seen by a general practitioner. They will be advised to achieve the current recommended targets for daily physical activity and educational material published by Health Canada (Canada's Physical Activity Guide, Health Canada). They will undergo treadmill tests at the start and end of each 1 year period. They will not receive the more frequent, targeted visits with a kinesiologist.

DASH-like diet and routine exercise

Healthy Heart Lipid Clinic, St. Paul's Hospital

Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba

Risk Factor Modification Centre, St. Michael's Hospital

Institute of Nutraceuticals and Functional Foods, Laval University

The Combined Portfolio Diet and Exercise Study

The First Cross-Canada Trial of the Nutrition Trialists' Network--Enhanced Dietary Portfolio and Exercise on Arterial Damage (MRI-Enhanced Dietary Portfolio Plus Exercise on Cardiovascular Risk)

MRI imaging assessment of the carotid arteries will be done at baseline, end of year 1 and year 3.

This will be assessed by MRI imaging of the Coronary and carotid arteries

This is a composite measure that would by done using an automatic digital BP monitor which simultaneously measures and displays systolic and diastolic pressure (mmHg) and pulse rate (bpm) readings on an output screen.

Assessment will be based on the current Canadian Cardiovascular Society Guidelines

Information will be obtained from medical records of participants affected

Information will be obtained from medical records of the participants

This will be used as a measure of retention

Serum lipids will be measured at each Centre on fasting serum. LDL-C will be calculated using the Friedewald equation. Serum lipid standards will be used to quality control the lipid analyses at the collaborating sites

safety monitoring especially for participants with type 2 diabetes

C-reactive protein will be measured at each Centre on fasting serum.

24 hr urine samples will be analyzed for creatinine, urea, C-peptide, minerals, electrolytes and other dietary biomarkers

In clinic assessment using a digital blood pressure monitor

Physical fitness testing to assess fitness level

7-day food records brought in at 3 monthly intervals will be analysed for macro and micro nutrient intakes.

7-day exercise/ activity records of the week prior to each study visit will be assessed for the type and duration of activity.

These will be assessed for the daily step count over a 7-day period prior to the specified time points for the test group only.

This will be done using a Medical Outcomes Study 36-Item Short Form Questionnaire (SF-36).

This will be measure on a scale to 1 to 10. 1 being 'strongly dislike' and 10 being 'like very much'. Participants will rate the taste (palatability) of the study diet and dietary components.

Using a 9-point bipolar semantic scale where -4 is extremely hungry, 0 is neutral and +4 is uncomfortably full, participants will rate their overall feeling of satiety for the previous week

Participants' preparedness to continue on the diet will be measured on a scale of 1 to 10. 1 = diet not sustainable; 10 = diet very sustainable

One time sample collection of buffy coat (from white cells) for future study on gene, diet, exercise and chronic disease relationship

Health check at start and yearly intervals

Health check at start and yearly intervals for male participants

The Montreal Cognitive Assessment (MoCA) (version 7.1 original version) will be administered at months 0, 12, 24 and 36. This tool measures different cognitive domains such as attention, concentration, memory, language etc.

St. Michael's Hospital, Toronto

Canadian Institutes of Health Research (CIHR)

University of Toronto

Laval University

University of Manitoba

University of British Columbia

The study supplementation will be introduced in the daily diet according to the participant preference to a total of 27g of Aleurone/day. One bread bun (35 g) contains 4.8 g Aleurone; one biscuit (15 g) contains 4 g Aleurone; 36 g of RTE cereals contain 9 g Aleurone.

The study supplementation will be introduced in the daily diet according to the participant preference to a total of 27g of Hemicellulose/day. One bread bun (35 g) contains 4.8 g Hemicellulose; one biscuit (15 g) contains 4 g Hemicellulose; 36 g of RTE cereals contain 9 g Hemicellulose. Placebo products contain the same levels of cellulose in place of aleurone's dietary fiber content.

Overweight

Healthy Subjects

Aleurone

Placebo

Fondazione Edmund Mach -Centro Ricerca ed Innovazione

Unità di Dietetica e Nutrizione Clinica, Ospedale S. Chiara, Via Orsi 1

Measuring the Impact of Dietary Supplementation With a High Fiber, High Antioxidant Aleurone on Biomarkers of Cardiovascular Disease and Gut Microbiota in Adults With High Body Mass Index

Change in total plasma homocysteine between timepoints week 2 (baseline) and week 6 (end of dietary supplementation).

plasma metabolites related to homocysteine metabolism (including betaine, dimethylglycine, methionine, choline, folate, riboflavin, vitamin B6).

MS analysis of metabolites related to microbial metabolism.

Faecal microbiota analysis by FISH, qPCR and 454 Roche pyrosequencing

MS analysis of fecal bile acid and fecal sterol concentrations

plasma and urine MS based metabolite profiling;
total cholesterol, triglycerides, LDL-, and HDL-cholesterol levels;
serum glucose and insulin levels;
anthropometric indices;
urinary isoprostane levels;
markers of intestinal permeability in plasma;
C-reactive protein levels as marker of inflammation

Francesca Fava

Fondazione Edmund Mach

Cargill R&D Centre Europe, Havenstraat 84, 1800 Vilvoorde, Belgium

Azienda Provinciale per i Servizi Sanitari della Provincia Autonoma di Trento

Patients on atorvastatin treatment hospitalised due to cardiovascular events

Cardiovascular Disorders

Patients on atorvastatin treatment

Rio University Hospital

Euroclinic Private Hospital

Evagelismos General State Hospital

Gennimatas General State Hospital

Konstantopoulio General Hospital

General State Hospital

University Hospital

Hippokration General Hospital

Sismanogleio General State Hospital

Tzannion General State Hospital

424 Military Hospital

Papageorgiou Hospital

Ekvasis of Atorvastatin (Antorcin®) Treatment in Patients With Acute Cardiovascular Events

A Multicenter, Open-label, 30-week Observational Clinical Study to Examine the Progress of Patients After Leaving the Cardiology Clinic or Unit Due to Acute Cardiovascular Event.

The evaluation of atorvastatin treatment to all patients with cardiovascular events and separate the two subgroups (diabetes type II patients with metabolic syndrome) in order to achieve the level of lipids (LDL-C, HDL-C, T-CHOL) plasma blood

Achieving the level of lipids (LDL-C, HDL-C, T-CHOL) in blood plasma of patients in the atorvastatin dosage: those who received the 40 mg dose and those who received a dose of 80 mg

The investigation of compliance to treatment (days without taking medication, changing the time of intake) and its correlation with the achievement of target lipid levels (LDL-C, HDL-C, T-CHOL) in blood plasma of the studied patients

Safety evaluation by adverse events reporting

The reporting of hematological and biochemical tests where conducted at each hospital center, as part of their standard clinical practice

The determination of dyslipidemia class it belongs to each patient in order to assess the efficacy of atorvastatin administered.

sterol/infarction

The Combined Portfolio Diet and Exercise Study

Measuring the Impact of Dietary Supplementation With a High Fiber, High Antioxidant Aleurone on Biomarkers of Cardiovascular Disease and Gut Microbiota in Adults With High Body Mass Index

Ekvasis of Atorvastatin (Antorcin®) Treatment in Patients With Acute Cardiovascular Events

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