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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02288585




Registration number
NCT02288585
Ethics application status
Date submitted
4/11/2014
Date registered
11/11/2014
Date last updated
19/01/2017

Titles & IDs
Public title
The Effect of Plant Sterols on the Blood Lipid Profile of Subjects With and at High Risk of Type 2 Diabetes Mellitus
Scientific 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
Secondary ID [1] 0 0
FDS-SCC-1552
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vascular Diseases 0 0
Hypercholesterolemia 0 0
Diabetes Mellitus 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Metabolic and Endocrine 0 0 0 0
Diabetes
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Plant sterols
Other interventions - Placebo product

Active Comparator: Plant sterols - Plant sterols

Placebo Comparator: Placebo product - Placebo product


Other interventions: Plant sterols
Plant sterols

Other interventions: Placebo product
Placebo product
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in TG concentrations
Timepoint [1] 0 0
At baseline (after 2 weeks run-in period) and after 6 weeks intervention
Primary outcome [2] 0 0
Change in LDL-C
Timepoint [2] 0 0
At baseline (after 2 weeks run-in period) and after 6 weeks intervention
Secondary outcome [1] 0 0
Change in blood lipids
Timepoint [1] 0 0
At baseline (after 2 weeks run-in period) and after 6 weeks intervention

Eligibility
Key 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.
Minimum age
30 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Basic Science
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2016
Sample size
Target
Accrual to date
Final
150
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
CSIRO - Adelaide
Recruitment hospital [2] 0 0
CSIRO, North Ryde - Sydney
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Unilever R&D
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Commonwealth Scientific and Industrial Research Organisation, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02288585
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Manny Noakes
Address 0 0
Commonwealth Scientific and Industrial Research Organisation, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02288585