Vascular DiseasesNCT02728583
The Effects of a Spread With Added Plant Sterols and Omega-3 Fatty Acids on Blood Lipids
A study testing Margarine enriched with plant sterols and fish oil in people with Vascular Diseases and Hypercholesterolemia, run by Unilever R&D at 1 site in Germany.
Trial summary
The main aim of the study is to investigate the effect of daily consumption of a margarine enriched with plant sterol esters and fish oil on fasting triglycerides (TG) concentrations. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Vascular Diseases, Hypercholesterolemia
- What is being tested?
- Margarine enriched with plant sterols and fish oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2016to Jan 2017
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fasting TG levels at screening: ≥ 1.40 and ≤ 5.60 mmol/L
- Fasting LDL-C levels at screening: ≥ 3.4 and ≤ 4.9 mmol/L
Who cannot join
- Recently (<6 months) diagnosed with cardiovascular event(s), revascularization or systemic inflammatory conditions.
- Medical history which might impact study measurements, to be judged by the study physician
- Use of over-the-counter and prescribed medication which may interfere with study measurements
- Reported weight loss or gain of 3 kg or more during a period of 2 months prior to screening.
- 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
1 site in 1 country.
About this study
Official title: The Effects of a Low-fat Spread With Added Plant Sterol Esters and Fish Omega-3 Fatty Acids on Blood Lipids
The main aim of the study is to investigate the effect of daily consumption of a margarine enriched with plant sterol esters and fish oil on fasting triglycerides (TG) concentrations.
The study also aims to investigate the effect of plant sterols and fish oil on fasting total cholesterol (TC), Low-density lipoprotein cholesterol (LDL-C), High-density lipoprotein cholesterol (HDL-C) and non-HDL-C.
At last, the effect of plant sterols and fish oil on fasting apolipoprotein concentrations will be explored.
Read the detailed description
The main aim of the study is to investigate the effect of daily consumption of a margarine enriched with plant sterol esters and fish oil on fasting TG concentrations.
The study also aims to investigate the effect of plant sterols and fish oil on fasting TC, LDL-C, HDL-C and non-HDL-C.
At last, the effect of plant sterols and fish oil on fasting apolipoprotein concentrations will be explored. This exploratory objective will only be analyzed if a relevant treatment effect on fasting triglycerides concentrations is observed.
- Conditions
- Vascular Diseases, Hypercholesterolemia
- Being tested
- Margarine enriched with plant sterols and fish oil, Placebo margarine
- Keywords
- Plant sterols, Fish oil, Blood lipids
- Medical subject headings
- Vascular Diseases, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Margarine enriched with plant sterols and fish oilDietary supplement
Placebo margarineDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Margarine enriched with plant sterols and fish oil | Active comparator | Low-fat margarine (25 g per day) with added plant sterols and Eicosapentaenoic acid (EPA) + Docosahexaenoic acid (DHA) from fish oil Receives: Dietary Supplement: Margarine enriched with plant sterols and fish oil |
| Placebo margarine | Placebo comparator | Low-fat margarine (25 g per day) without added plant sterols and EPA + DHA Receives: Dietary Supplement: Placebo margarine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in TG concentrations
Two samples will be taken at baseline (Day -1 and 1) and two samples at the end of intervention (Day 28 and 29)
Measured: At baseline (after 2 weeks run-in period) and after 4 weeks intervention
Secondary outcomes (1)
Change in blood lipids
Two samples will be taken at baseline (Day -1 and 1) and two samples at the end of intervention (Day 28 and 29)
Measured: At baseline (after 2 weeks run-in period) and after 4 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionNov 2016
- Study completionJan 2017
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
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wieneke Koppenol, MSc, Study director, Unilever R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728583
- Sponsor's protocol ID
- FDS-SCC-2150
- Status last verified
- Jan 2017
- First submitted
- 30 Mar 2016
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Blom WAM, Koppenol WP, Hiemstra H, Stojakovic T, Scharnagl H, Trautwein EA. A low-fat spread with added plant sterols and fish omega-3 fatty acids lowers serum triglyceride and LDL-cholesterol concentrations in individuals with modest hypercholesterolaemia and hypertriglyceridaemia. Eur J Nutr. 2019 Jun;58(4):1615-1624. doi: 10.1007/s00394-018-1706-1. Epub 2018 May 3.
PubMed 29725824
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 Effects of a Low-fat Spread With Added Plant Sterol Esters and Fish Omega-3 Fatty Acids on Blood Lipids
- ClinicalTrials.gov ID
- NCT02728583
- Acronym / sponsor ID
- FDS-SCC-2150
- Conditions
- Vascular Diseases, Hypercholesterolemia
- Keywords
- Plant sterols, Fish oil, Blood lipids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 5 Apr 2016 (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.
The main aim of the study is to investigate the effect of daily consumption of a margarine enriched with plant sterol esters and fish oil on fasting triglycerides (TG) concentrations.
The study also aims to investigate the effect of plant sterols and fish oil on fasting total cholesterol (TC), Low-density lipoprotein cholesterol (LDL-C), High-density lipoprotein cholesterol (HDL-C) and non-HDL-C.
At last, the effect of plant sterols and fish oil on fasting apolipoprotein concentrations will be explored.
Detailed description
The main aim of the study is to investigate the effect of daily consumption of a margarine enriched with plant sterol esters and fish oil on fasting TG concentrations.
The study also aims to investigate the effect of plant sterols and fish oil on fasting TC, LDL-C, HDL-C and non-HDL-C.
At last, the effect of plant sterols and fish oil on fasting apolipoprotein concentrations will be explored. This exploratory objective will only be analyzed if a relevant treatment effect on fasting triglycerides concentrations is observed.
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 |
|---|---|---|
| Margarine enriched with plant sterols and fish oil | Active comparator | Dietary Supplement: Margarine enriched with plant sterols and fish oilLow-fat margarine (25 g per day) with added plant sterols and Eicosapentaenoic acid (EPA) + Docosahexaenoic acid (DHA) from fish oil |
| Placebo margarine | Placebo comparator | Dietary Supplement: Placebo margarineLow-fat margarine (25 g per day) without added plant sterols and EPA + DHA |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fasting TG levels at screening: ≥ 1.40 and ≤ 5.60 mmol/L
- Fasting LDL-C levels at screening: ≥ 3.4 and ≤ 4.9 mmol/L
Key exclusion criteria (5 listed)
- Recently (<6 months) diagnosed with cardiovascular event(s), revascularization or systemic inflammatory conditions.
- Medical history which might impact study measurements, to be judged by the study physician
- Use of over-the-counter and prescribed medication which may interfere with study measurements
- Reported weight loss or gain of 3 kg or more during a period of 2 months prior to screening.
- 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 |
|---|---|---|
| Margarine enriched with plant sterols and fish oil | Dietary supplement | Margarine enriched with plant sterols and fish oil |
| Placebo margarine | Dietary supplement | Placebo margarine |
Primary outcome
Change in TG concentrations
Time frame: At baseline (after 2 weeks run-in period) and after 4 weeks intervention
Two samples will be taken at baseline (Day -1 and 1) and two samples at the end of intervention (Day 28 and 29)
1 secondary outcome
Change in blood lipids
Time frame: At baseline (after 2 weeks run-in period) and after 4 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 29725824Blom WAM, Koppenol WP, Hiemstra H, Stojakovic T, Scharnagl H, Trautwein EA. A low-fat spread with added plant sterols and fish omega-3 fatty acids lowers serum triglyceride and LDL-cholesterol concentrations in individuals with modest hypercholesterolaemia and hypertriglyceridaemia. Eur J Nutr. 2019 Jun;58(4):1615-1624. doi: 10.1007/s00394-018-1706-1. Epub 2018 May 3.
- Individual participant dataSharing planned: No
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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.
Wieneke Koppenol, MSc study director
Unilever R&D
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Margarine enriched with plant sterols and fish oil in people with Vascular Diseases and Hypercholesterolemia, run by Unilever R&D at 1 site in Germany.
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 2 inclusion and 5 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 1 site in Germany. 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 4 weeks intervention). 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 NCT02728583, 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.