Vascular Diseases, Hypercholesterolemia, Diabetes Mellitus
Conditions
Keywords
plant sterols, blood lipids
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.
Interventions
DIETARY_SUPPLEMENTPlant sterols
Plant sterols
DIETARY_SUPPLEMENTPlacebo product
Placebo product
Sponsors
Commonwealth Scientific and Industrial Research Organisation, Australia
Unilever R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Change in blood lipids | At baseline (after 2 weeks run-in period) and after 6 weeks intervention |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in blood glucose | At baseline (after 2 weeks run-in period) and after 6 weeks intervention | — |
| Change in Advanced Glycation End products (AGEs) | At baseline (after 2 weeks run-in period) and after 6 weeks intervention | — |
| Change in insulin | At baseline (after 2 weeks run-in period) and after 6 weeks intervention | — |
| Acute, chronic and acute upon chronic effect on postprandial lipids, glucose and insulin | At the end of intervention (after 6 weeks) | In a sub-group (n=48) of the population |
Countries
Australia
Outcome results
None listed