Status:
COMPLETED
The Effect of Plant Sterols on the Blood Lipid Profile of Subjects With and at High Risk of Type 2 Diabetes Mellitus
Lead Sponsor:
Unilever R&D
Collaborating Sponsors:
Commonwealth Scientific and Industrial Research Organisation, Australia
Conditions:
Vascular Diseases
Hypercholesterolemia
Eligibility:
All Genders
30-75 years
Phase:
NA
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-cholestero...
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 fasti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT02288585
Start Date
October 1 2014
End Date
December 1 2016
Last Update
January 19 2017
Active Locations (2)
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1
CSIRO
Adelaide, Australia
2
CSIRO, North Ryde
Sydney, Australia