Vascular DiseasesNCT02288585
The Effect of Plant Sterols on the Blood Lipid Profile of Subjects With and at High Risk of Type 2 Diabetes Mellitus
A study testing Plant sterols in people with Vascular Diseases and Hypercholesterolemia, run by Unilever R&D at 2 sites in Australia.
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… Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Vascular Diseases, Hypercholesterolemia, Diabetes Mellitus
- What is being tested?
- Plant sterols
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesAustralia
- Study dates
- Oct 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Plant sterols, Placebo product
- Keywords
- plant sterols, blood lipids
- Medical subject headings
- Vascular Diseases, Hypercholesterolemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant sterolsDietary supplement
Plant sterols
Placebo productDietary supplement
Placebo product
| Study group | Role | What they receive |
|---|---|---|
| Plant sterols | Active comparator | Plant sterols Receives: Dietary Supplement: Plant sterols |
| Placebo product | Placebo comparator | Placebo product Receives: Dietary Supplement: Placebo product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in TG concentrations
Measured: At baseline (after 2 weeks run-in period) and after 6 weeks intervention
Change in LDL-C
Measured: At baseline (after 2 weeks run-in period) and after 6 weeks intervention
Secondary outcomes (1)
Change in blood lipids
Measured: At baseline (after 2 weeks run-in period) and after 6 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Commonwealth Scientific and Industrial Research Organisation, Australia
- Responsible party
- Sponsor
- Investigators
- Manny Noakes, Principal investigator, Commonwealth Scientific and Industrial Research Organisation, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02288585
- Sponsor's protocol ID
- FDS-SCC-1552
- Status last verified
- Jan 2017
- First submitted
- 4 Nov 2014
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29795368
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02288585
- Acronym / sponsor ID
- FDS-SCC-1552
- Conditions
- Vascular Diseases, Hypercholesterolemia, Diabetes Mellitus
- Keywords
- plant sterols, blood lipids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Collaborators
- Commonwealth Scientific and Industrial Research Organisation, Australia
- Study start
- Oct 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plant sterols | Active comparator | Dietary Supplement: Plant sterolsPlant sterols |
| Placebo product | Placebo comparator | Dietary Supplement: Placebo productPlacebo product |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plant sterolsPlant sterols | Dietary supplement | Plant sterols |
| Placebo productPlacebo product | Dietary supplement | Placebo product |
Primary outcome
Change in TG concentrations
Time frame: At baseline (after 2 weeks run-in period) and after 6 weeks intervention
Change in LDL-C
Time frame: At baseline (after 2 weeks run-in period) and after 6 weeks intervention
1 secondary outcome
Change in blood lipids
Time frame: At baseline (after 2 weeks run-in period) and after 6 weeks intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
- Derived from this study: PubMed 29795368Trautwein 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manny Noakes principal investigator
Commonwealth Scientific and Industrial Research Organisation, Australia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant sterols in people with Vascular Diseases and Hypercholesterolemia, run by Unilever R&D at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in TG concentrations (time frame: At baseline (after 2 weeks run-in period) and after 6 weeks intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02288585, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2017.