Back to resultsThe Effect of Plant Sterols on the Blood Lipid Profile of Subjects With and at High Risk of Type 2 Diabetes Mellitus
Primary Purpose
Vascular Diseases, Hypercholesterolemia, Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Plant sterols
Placebo product
Sponsored by
About this trial
This is an interventional basic science trial for Vascular Diseases focused on measuring plant sterols, blood lipids
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.
Sites / Locations
- CSIRO
- CSIRO, North Ryde
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Plant sterols
Placebo product
Arm Description
Plant sterols
Placebo product
Outcomes
Primary Outcome Measures
Change in TG concentrations
Change in LDL-C
Secondary Outcome Measures
Change in blood lipids
Full Information
NCT ID
NCT02288585
First Posted
November 4, 2014
Last Updated
January 18, 2017
Sponsor
Unilever R&D
Collaborators
Commonwealth Scientific and Industrial Research Organisation, Australia
1. Study Identification
Unique Protocol Identification Number
NCT02288585
Brief Title
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
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unilever R&D
Collaborators
Commonwealth Scientific and Industrial Research Organisation, Australia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Diseases, Hypercholesterolemia, Diabetes Mellitus
Keywords
plant sterols, blood lipids
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Plant sterols
Arm Type
Active Comparator
Arm Description
Plant sterols
Arm Title
Placebo product
Arm Type
Placebo Comparator
Arm Description
Placebo product
Intervention Type
Dietary Supplement
Intervention Name(s)
Plant sterols
Intervention Description
Plant sterols
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo product
Intervention Description
Placebo product
Primary Outcome Measure Information:
Title
Change in TG concentrations
Time Frame
At baseline (after 2 weeks run-in period) and after 6 weeks intervention
Title
Change in LDL-C
Time Frame
At baseline (after 2 weeks run-in period) and after 6 weeks intervention
Secondary Outcome Measure Information:
Title
Change in blood lipids
Time Frame
At baseline (after 2 weeks run-in period) and after 6 weeks intervention
Other Pre-specified Outcome Measures:
Title
Change in blood glucose
Time Frame
At baseline (after 2 weeks run-in period) and after 6 weeks intervention
Title
Change in insulin
Time Frame
At baseline (after 2 weeks run-in period) and after 6 weeks intervention
Title
Acute, chronic and acute upon chronic effect on postprandial lipids, glucose and insulin
Description
In a sub-group (n=48) of the population
Time Frame
At the end of intervention (after 6 weeks)
Title
Change in Advanced Glycation End products (AGEs)
Time Frame
At baseline (after 2 weeks run-in period) and after 6 weeks intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manny Noakes
Organizational Affiliation
Commonwealth Scientific and Industrial Research Organisation, Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
CSIRO
City
Adelaide
Country
Australia
Facility Name
CSIRO, North Ryde
City
Sydney
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
29795368
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.
Results Reference
derived
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The Effect of Plant Sterols on the Blood Lipid Profile of Subjects With and at High Risk of Type 2 Diabetes Mellitus
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