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

Not Applicable

Completed

• Conditions: Vascular Diseases; Diabetes Mellitus; Hypercholesterolemia
• Interventions: Dietary Supplement: Placebo product; Dietary Supplement: Plant sterols

• Registration Number: NCT02288585
• Lead Sponsor: Unilever R&D

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-11-04
• Study First Submitted QC: 2014-11-06
• Study First Posted: 2014-11-11
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo product	Placebo product	Placebo product
Plant sterols	Plant sterols	Plant sterols

Primary Outcome Measures

Name	Time	Method
Change in TG concentrations	At baseline (after 2 weeks run-in period) and after 6 weeks intervention
Change in LDL-C	At baseline (after 2 weeks run-in period) and after 6 weeks intervention

Secondary Outcome Measures

Name	Time	Method
Change in blood lipids	At baseline (after 2 weeks run-in period) and after 6 weeks intervention

Trial Locations

Locations (2)

CSIRO, North Ryde; 🇦🇺 Sydney, Australia

CSIRO; 🇦🇺 Adelaide, Australia