The Effect of Plant Sterols on the Blood Lipid Profile of Subjects With and at High Risk of Type 2 Diabetes Mellitus

Unilever

Status

Completed

Conditions

Hypercholesterolemia

Diabetes Mellitus

Vascular Diseases

Treatments

Dietary Supplement: Placebo product

Dietary Supplement: Plant sterols

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02288585

FDS-SCC-1552

Details and patient eligibility

About

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.

Full description

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.

Enrollment

150 patients

Sex

All

Ages

30 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Triglycerides >150 mg/dL or 1.74 mmol/L
LDL-cholesterol: Subjects at high risk for developing T2DM: 115-190 mg/dL or 2.95-4.94 mmol/L. Subjects with established T2DM that are on statins: 85-190 mg/dL or 2.15-4.94 mmol/L.
HbA1c: Subjects at high risk for developing T2DM: <6.50% or ≥ 48 mmol/mol. Subjects with established T2DM: ≤ 8.5% or ≤ 69 mmol/mol.
BMI > 20.0 kg/m2.

Exclusion criteria

Recently (within 1 year) diagnosed with cardiovascular event(s) (stroke, TIA, angina, myocardial infarction, heart failure), systemic inflammatory conditions
Use of over-the-counter and prescribed medication which may interfere with study measurements (i.e. ezetimibe, fibrates and Niacin), to be judged by the principal investigator.
Currently smoking or being a non-smoker for less than 6 months and reported use of any nicotine containing products in the 6 months prior to screening and/or during the study.