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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Vascular Diseases Hypercholesterolemia Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Plant sterols

Group Type ACTIVE_COMPARATOR

Plant sterols

Intervention Type DIETARY_SUPPLEMENT

Plant sterols

Placebo product

Group Type PLACEBO_COMPARATOR

Placebo product

Intervention Type DIETARY_SUPPLEMENT

Placebo product

Interventions

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Plant sterols

Intervention Type DIETARY_SUPPLEMENT

Placebo product

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes