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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02288585
• Other study ID #: FDS-SCC-1552
• Status: Completed
• Phase: N/A
• First received: November 4, 2014
• Last updated: January 18, 2017
• Start date: October 2014
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Unilever R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypercholesterolemia
• Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
Australia	CSIRO	Adelaide
Australia	CSIRO, North Ryde	Sydney

Sponsors (2)

Lead Sponsor	Collaborator
Unilever R&D	CSIRO

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in blood glucose		At baseline (after 2 weeks run-in period) and after 6 weeks intervention
Other	Change in insulin		At baseline (after 2 weeks run-in period) and after 6 weeks intervention
Other	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)
Other	Change in Advanced Glycation End products (AGEs)		At baseline (after 2 weeks run-in period) and after 6 weeks intervention
Primary	Change in TG concentrations		At baseline (after 2 weeks run-in period) and after 6 weeks intervention
Primary	Change in LDL-C		At baseline (after 2 weeks run-in period) and after 6 weeks intervention
Secondary	Change in blood lipids		At baseline (after 2 weeks run-in period) and after 6 weeks intervention