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

Unilever R&D150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

150

Conditions

Vascular Diseases Hypercholesterolemia Diabetes Mellitus

Interventions

Plant sterolsDIETARY_SUPPLEMENT

Plant sterols

Placebo productDIETARY_SUPPLEMENT

Placebo product

Eligibility

Sex: ALLMin age: 30 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

CSIRO

Adelaide, Australia

CSIRO, North Ryde

Sydney, Australia

Outcomes

Primary Outcomes

Change in TG concentrations

Time frame: At baseline (after 2 weeks run-in period) and after 6 weeks intervention

Change in LDL-C

Time frame: At baseline (after 2 weeks run-in period) and after 6 weeks intervention

Secondary Outcomes

Change in blood lipids

Time frame: At baseline (after 2 weeks run-in period) and after 6 weeks intervention

Data from ClinicalTrials.gov

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