Diabetes Mellitus Clinical Trial
Official title:
The Effect of a Low-fat Spread Enriched With Plant Sterol Esters on the Blood Lipid Profile of Subjects With Established Type 2 Diabetes Mellitus and Subjects at High Risk of Developing Type 2 Diabetes
Double-blind, randomised, placebo-controlled, parallel group study with two intervention arms. The study will be conducted in 150 subjects and the primary objective is to show a fasting LDL-cholesterol and triglyceride lowering effect of plant sterols in subjects with established type 2 diabetes mellitus and subjects at high risk of developing type 2 diabetes.
The main aim of the study is to investigate the effect of plant sterols on fasting
triglycerides and LDL-cholesterol concentrations.
This study also aims to study the effect of plant sterols on fasting total cholesterol,
HDL-cholesterol concentrations and Lipoprotein (a). Furthermore the effects of plant sterols
on fasting blood glucose and insulin will be explored. At last, in a sub-group, at end of
intervention the acute, chronic and acute upon chronic effect of plant sterols on
postprandial blood lipids, glucose and insulin responses during a mixed meal challenge rich
in fat and carbohydrates will be explored.
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