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Hypercholesterolemia clinical trials

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NCT ID: NCT01581697 Recruiting - Atherosclerosis Clinical Trials

Impact of Consumption of Oats in Lipid Profile of Children and Adolescents With Dyslipidemia

Start date: n/a
Phase: Phase 1/Phase 2
Study type: Interventional

Atherosclerosis is the leading cause of death and disability in adults. However, investigations suggest that the basic pathology of heart disease as more severe myocardial infarction which usually reach mainly middle-aged or above, starts from childhood. Hypercholesterolemia is one of the most important risk factors for atherosclerosis in adults and children, is associated with early deposition of lipids in the aorta and coronary arteries. Among other recommendations for prevention and treatment of heart disease and risk factors, is the recommendation to encourage the intake of soluble fiber. The oats, a major source of soluble fiber, has been recognized as a potential component of the diet to lower blood cholesterol levels, this effect is attributed mainly to the beta-glucan, a type of soluble fiber present in large quantities in oats. In 1997 the Food and Drug Administration admitted that the oat bran, oat flakes and oatmeal may have beneficial effects for health with the recommendation of daily intake of 3g of beta-glucan from oats and a food that brings a claim for promotion health, must provide, without enrichment, at least 1 gram of beta-glucan per serving. The objective of this project will be compared by randomized clinical trial, the impact of intake of oats, for 8 weeks in the lipid profile of children and adolescents with dyslipidemia. Will be included in the study 120 volunteers aged between 5 and 16 years who are in nutritional monitoring for at least 1 month. The subjects will be randomly divided into 2 groups, with a control group and another intervention will receive 3 tablespoons of soup filled with oat bran, which corresponds to 3g of beta-glucan, along with breakfast, lunch and dinner. Patients will be monitored with consultations on the 2nd, 4th and 8th weeks of treatment. Blood sample will be performed, to obtain the lipid profile of patients, at the beginning and end of the study. To compare the groups are used Student's t and squared chi. The alpha of 0.05 is considered critical. The program will be used Statistical Package for the Social Sciences (SPSS) version 15.0. It is expected a decrease in serum levels of total cholesterol and LDL-c. Thus, living habits and healthy alternatives to prevent these risk factors should be done since childhood, especially in children who already have cholesterol levels of change.

NCT ID: NCT01580319 Terminated - Obesity Clinical Trials

Primary Prevention of Cardiovascular Diseases in Childhood and Adolescence: the Role of Physical Activity

Start date: April 2009
Phase: N/A
Study type: Interventional

This research project is about a physical activity intervention in pediatric outpatients to try control and prevent heart diseases such as hypertension, obesity, high cholesterol.

NCT ID: NCT01577056 Not yet recruiting - Clinical trials for Familial Hypercholesterolaemia

Postprandial Lipid Metabolism in Familial Hypercholesterolaemia:Effects of Fish Oils

FIFH
Start date: April 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether fish oil supplementation is effective in the treatment of abnormal fat metabolism in subjects with elevated cholesterolaemia.

NCT ID: NCT01576484 Completed - Clinical trials for Hypercholesterolemia

Open-Label Extension of Study R727-CL-1003 (NCT01266876) to Evaluate the Long-Term Safety and Efficacy of Alirocumab (REGN727) in Participants With Heterozygous Familial Hypercholesterolemia (HeFH)

Start date: February 28, 2012
Phase: Phase 2
Study type: Interventional

The primary objective of the study was to assess the long-term safety and tolerability of alirocumab in patients with heFH who were receiving concomitant treatment with hydroxymethyl glutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins), with or without other lipid-modifying therapies (LMTs).

NCT ID: NCT01575171 Completed - Clinical trials for Hypercholesterolemia

Using Nudges to Implement Comparative Effectiveness

Start date: September 2010
Phase: N/A
Study type: Observational

Behavioral economics represents a powerful, albeit underutilized tool to influence provider and systems behavior in a large-scale, meaningful, and sustainable way. The investigators propose to use a sophisticated electronic health record (EHR) system to change the default choice for physicians to the choice most supported by clinical practice guidelines (CPG). Multiple guidelines exist describing best practices for effective interventions, yet a large gap persists between actual and optimal guideline compliance. The proposed study will examine the comparative effectiveness of an opt-out medication management protocol relative to usual care for patients not at goal, using national guidelines for cholesterol management implemented in large multispecialty private practices that use an Electronic Health Record system. Specific Aim: To determine the effectiveness of altering the default option in an EHR in prescribing statins to selected patients using clinical decision support. Hypotheses: Compared to usual care, a CPG-concordant intervention designed using behavioral economics principles will significantly improve the proportion of patients who are prescribed statins.

NCT ID: NCT01574482 Completed - Clinical trials for Mildly Hypercholesterolemic Subjects

Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols (Italy)

Start date: January 2007
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the cholesterol lowering effect of a drinkable low fat fermented milk enriched with plant sterol after 3 and 6 weeks of daily consumption in mildly hypercholesterolemic people treated or not by statins

NCT ID: NCT01574417 Completed - Clinical trials for Hypercholesterolemia

Plant Stanols and Gene Expression Profile

Start date: March 2012
Phase: N/A
Study type: Interventional

Plant sterols and stanols are dietary components that are naturally present in plants. Their biological function in plants is comparable with these of cholesterol in animals. They are structurally related to cholesterol, but are absorbed by enterocytes to a much lesser extent. It is generally accepted that they inhibit intestinal cholesterol absorption and consequently lower serum low-density lipoprotein (LDL) cholesterol concentrations up to 10% at daily intakes of 2.5 g. The exact underlying mechanism of the plant sterol/stanol mediated reduction in intestinal cholesterol absorption is still unknown. It has been suggested that they lower the activity of sterol uptake transporters like Niemann-Pick C1 like 1 protein (NPC1L1) in enterocytes, otherwise several studies indicated that these compounds could activate the liver X receptor (LXR) in enterocytes, thereby activating the ABC transporters involved in the intestinal cholesterol metabolism, whereas recently suggestions have been made that plant sterols and stanols activate transintestinal cholesterol excretion (TICE). This is the direct cholesterol secretion from the blood into the intestinal lumen, in which the enterocytes play a central role. None of these assumptions have so far been evaluated in humans. Objective: The major objective of the present study is to examine the acute effects of dietary plant stanol esters on the intestinal mucosal gene expression profiles in intestinal biopsies in healthy volunteers. The minor objective is to investigate whether semi-long-term use (3 weeks) of plant stanol esters have an effect on microbiota composition.

NCT ID: NCT01571882 Completed - Clinical trials for Mildly Hypercholesterolemic Subjects

Effects of Fermented Milk Product Enriched With Plant Sterols and Policosanols in Mild Hypercholesterolaemic Adults

Start date: June 2007
Phase: N/A
Study type: Interventional

The objective of this study is to investigate the effect of consumption of a low-fat, no added sugar, dairy fermented product enriched with plant sterols and policosanols at two doses, on LDL-cholesterol concentration in hypercholesterolaemic adults after 3 weeks of product consumption versus active control product.

NCT ID: NCT01571869 Completed - Clinical trials for Mildly Hypercholesterolemic Subjects

Pilot Study in the Cholesterol Absorption Reduction After Consumption of Low-fat, Drinkable Fermented Milk Enriched With Plant Sterols

Start date: April 2005
Phase: N/A
Study type: Interventional

The objective of this study is to compare efficacy of a plant sterol enriched yogurt given at different moments of the day in lowering blood cholesterol of hypercholesterolemic.

NCT ID: NCT01570270 Completed - Clinical trials for Hypercholesterolemia

Cheese Intake and Hypercholesterolemia

Start date: May 2009
Phase: Phase 1/Phase 2
Study type: Interventional

In this study the investigators aimed at verifying whether consumption of a sheep cheese, naturally enriched in alpha-lipoic acid (ALA), conjugated linoleic acid (CLA) and vaccenic acid (VA), would modify the plasma lipid and endocannabinoid profiles in mild hypercholesterolemic subjects.