NCT02288585

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Unilever R&D · Industry
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Vascular Diseases
• Hypercholesterolemia
• Diabetes Mellitus

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Plant sterols	Plant sterols
DIETARY_SUPPLEMENT	Placebo product	Placebo product

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2014-11-11
• Last updated: 2017-01-19

Locations

2 sites across 1 country: Australia