Clinical trial NCT02288585: The Effect of Plant Sterols on the Blood Lipid Profile of Subjects With and at High Risk of Type 2 Diabetes Mellitus
Official title: 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: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Diseases
Hypercholesterolemia
Diabetes Mellitus
Keywords: plant sterols
blood lipids
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
Collaborators: name: Commonwealth Scientific and Industrial Research Organisation, Australia
First posted: 2014-11-11
Enrollment: 150
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in TG concentrations
timeFrame: At baseline (after 2 weeks run-in period) and after 6 weeks intervention
measure: Change in LDL-C
timeFrame: At baseline (after 2 weeks run-in period) and after 6 weeks intervention
Secondary outcomes:
measure: Change in blood lipids
timeFrame: At baseline (after 2 weeks run-in period) and after 6 weeks intervention
Other outcomes:
measure: Change in blood glucose
timeFrame: At baseline (after 2 weeks run-in period) and after 6 weeks intervention
measure: Change in insulin
timeFrame: At baseline (after 2 weeks run-in period) and after 6 weeks intervention
measure: Acute, chronic and acute upon chronic effect on postprandial lipids, glucose and insulin
timeFrame: At the end of intervention (after 6 weeks)
measure: Change in Advanced Glycation End products (AGEs)
timeFrame: At baseline (after 2 weeks run-in period) and after 6 weeks intervention
Locations:
city: Adelaide
country: Australia
facility: CSIRO
city: Sydney
country: Australia
facility: CSIRO, North Ryde
Study officials:
affiliation: Commonwealth Scientific and Industrial Research Organisation, Australia
name: Manny Noakes
role: PRINCIPAL_INVESTIGATOR
References:
citation: Trautwein EA, Koppenol WP, de Jong A, Hiemstra H, Vermeer MA, Noakes M, Luscombe-Marsh ND. Plant sterols lower LDL-cholesterol and triglycerides in dyslipidemic individuals with or at risk of developing type 2 diabetes; a randomized, double-blind, placebo-controlled study. Nutr Diabetes. 2018 May 25;8(1):30. doi: 10.1038/s41387-018-0039-8.