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

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2016

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.

Interventions

  • Dietary Supplement: Plant sterols
    • Plant sterols
  • Dietary Supplement: Placebo product
    • Placebo product

Arms, Groups and Cohorts

  • Active Comparator: Plant sterols
    • Plant sterols
  • Placebo Comparator: Placebo product
    • Placebo product

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Change in blood lipids
    • Time Frame: At baseline (after 2 weeks run-in period) and after 6 weeks intervention

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Unilever R&D
  • Collaborator
    • Commonwealth Scientific and Industrial Research Organisation, Australia
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Manny Noakes, Principal Investigator, Commonwealth Scientific and Industrial Research Organisation, Australia

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.