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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
CSIRO
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/show/NCT02288585
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Manny Noakes
Address 0 0
CSIRO
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
Other publications