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

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

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.

Study Overview

• Status: Completed
• Conditions: Vascular Diseases; Diabetes Mellitus; Hypercholesterolemia
• Intervention / Treatment: Dietary supplement: Plant sterols; Dietary supplement: Placebo product

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia
    • CSIRO
  • Sydney, Australia
    • CSIRO, North Ryde

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Plant sterols	Dietary supplement: Plant sterols; Plant sterols
Placebo Comparator: Placebo product	Dietary supplement: Placebo product; Placebo product

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood glucose		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	In a sub-group (n=48) of the population	At the end of intervention (after 6 weeks)
Change in Advanced Glycation End products (AGEs)		At baseline (after 2 weeks run-in period) and after 6 weeks intervention

Collaborators and Investigators

• Sponsor: Unilever R&D
• Collaborators: Commonwealth Scientific and Industrial Research Organisation, Australia
• Investigators: Principal Investigator: Manny Noakes, Commonwealth Scientific and Industrial Research Organisation, Australia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: November 4, 2014
• First Submitted That Met QC Criteria: November 6, 2014
• First Posted (Estimate): November 11, 2014

Study Record Updates

• Last Update Posted (Estimate): January 19, 2017
• Last Update Submitted That Met QC Criteria: January 18, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: plant sterols; blood lipids
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Diabetes Mellitus; Diabetes Mellitus, Type 2; Vascular Diseases; Hypercholesterolemia
• Other Study ID Numbers: FDS-SCC-1552