HealthyNCT01313988
Efficacy Study on the Lipid-lowering Effect of Plant Sterols and Fish Oil
A study testing Plant sterols and fish oil and Plant sterols in people with Healthy and Mildly Elevated Cholesterol Levels, run by Unilever R&D at 1 site in Sweden.
Trial summary
Plant sterols and fish fatty acids are known to affect the blood lipid profile. This randomized, double-blind, placebo-controlled, parallel efficacy study is designed to investigate the lipid-lowering effect after 4 weeks intervention with the recommended dose of plant sterols and different doses of fish fatty acids… Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Mildly Elevated Cholesterol Levels
- What is being tested?
- Plant sterols and fish oil and Plant sterols
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 332 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2011to Jan 2012
- 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 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Apparently healthy men and women
- Age ≥ 25 and ≤ 75 years old
- Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2
- Total cholesterol levels at screening ≥ 5.0 and ≤ 8.0 mmol/L
- 10-year CVD risk equal or lower than 10% according to "SCORE"
- Blood pressure, heart rate, hematological parameters, clinical chemical parameters within normal reference ranges
Show all 12Show fewer
- Informed consent and biobank consent signed
- Willing to comply to study protocol during study
- Agreeing to be informed about medically relevant personal test-results by a physician
- Not smoking
- Accessible veins on the forearm
- Habitually consuming spreads
Who cannot join
- Pregnant or having the wish to become pregnant, or lactating
- Use of prescribed medication which may interfere with study measurements
- Use of antibiotics in the 3 months before screening or during the study
- Use of any medically- or self-prescribed diet with the purpose to reduce weight
- Intolerance for gluten or lactose
- Reported food allergy
Show all 13Show fewer
- Having bleeding disorders
- Recent blood donation
- Excessive alcohol consumption
- Strenuous exercise
- Reported weight change ≥ 10 % of body weight or use of prescribed weight reduction drugs
- Recent participation in another nutritional or medical trial
- Participation in night shift work
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy Study on the Lipid-lowering Effect of a Spread Enriched With the Recommended Dose of Plant Sterols and 3 Different Doses of Fatty Acids From Fish Oil
Plant sterols and fish fatty acids are known to affect the blood lipid profile. This randomized, double-blind, placebo-controlled, parallel efficacy study is designed to investigate the lipid-lowering effect after 4 weeks intervention with the recommended dose of plant sterols and different doses of fish fatty acids when combined in a spread format.
- Conditions
- Healthy, Mildly Elevated Cholesterol Levels
- Being tested
- Plant sterols and fish oil, Plant sterols, Placebo
- Keywords
- dose-response study, blood lipid profile, plant sterols, fish oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant sterols and fish oilDietary supplement
4 weeks intervention, 3 times daily
Plant sterolsDietary supplement
4 weeks intervention, 3 times daily
PlaceboDietary supplement
4 weeks, 3 times daily
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 | Active comparator | Spread that contains plant sterols and fish oil Receives: Dietary Supplement: Plant sterols and fish oil |
| Dose 2 | Active comparator | Spread that contains plant sterols and fish oil Receives: Dietary Supplement: Plant sterols and fish oil |
| Dose 3 | Active comparator | Spread that contains plant sterols and fish oil Receives: Dietary Supplement: Plant sterols and fish oil |
| Placebo | Placebo comparator | Placebo spread Receives: Dietary Supplement: Placebo |
| Control | Active comparator | Spread that contains plant sterols Receives: Dietary Supplement: Plant sterols |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood lipid profile
Includes total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides
Measured: At baseline (after 4 weeks run-in period) and after 4 weeks intervention
Secondary outcomes (2)
Change in EPA/DHA in red blood cells
Measured: At baseline (after 4 weeks run-in period) and after 4 weeks intervention
Change in metabolomic parameters
For exploratory purposes
Measured: At baseline (after 4 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 posted14 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2012
- Study completionJan 2012
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 HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johan Olsson, PhD, Principal investigator, KPL Good Food Practice ABBirgitta Sundberg, PhD, Study director, KPL Good Food Practice ABAnneli Hallmin, Study director, KPL Good Food Practice AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01313988
- Sponsor's protocol ID
- 10018V
- Status last verified
- Jan 2012
- First submitted
- 2 Mar 2011
- Last updated
- 7 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Ras RT, Demonty I, Zebregs YE, Quadt JF, Olsson J, Trautwein EA. Low doses of eicosapentaenoic acid and docosahexaenoic acid from fish oil dose-dependently decrease serum triglyceride concentrations in the presence of plant sterols in hypercholesterolemic men and women. J Nutr. 2014 Oct;144(10):1564-70. doi: 10.3945/jn.114.192229. Epub 2014 Aug 13.
PubMed 25122648
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study on the Lipid-lowering Effect of a Spread Enriched With the Recommended Dose of Plant Sterols and 3 Different Doses of Fatty Acids From Fish Oil
- ClinicalTrials.gov ID
- NCT01313988
- Acronym / sponsor ID
- 10018V
- Conditions
- Healthy, Mildly Elevated Cholesterol Levels
- Keywords
- dose-response study, blood lipid profile, plant sterols, fish oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 14 Mar 2011 (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.
Plant sterols and fish fatty acids are known to affect the blood lipid profile. This randomized, double-blind, placebo-controlled, parallel efficacy study is designed to investigate the lipid-lowering effect after 4 weeks intervention with the recommended dose of plant sterols and different doses of fish fatty acids when combined in a spread format.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose 1 | Active comparator | Dietary Supplement: Plant sterols and fish oilSpread that contains plant sterols and fish oil |
| Dose 2 | Active comparator | Dietary Supplement: Plant sterols and fish oilSpread that contains plant sterols and fish oil |
| Dose 3 | Active comparator | Dietary Supplement: Plant sterols and fish oilSpread that contains plant sterols and fish oil |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo spread |
| Control | Active comparator | Dietary Supplement: Plant sterolsSpread that contains plant sterols |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Apparently healthy men and women
- Age ≥ 25 and ≤ 75 years old
- Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2
- Total cholesterol levels at screening ≥ 5.0 and ≤ 8.0 mmol/L
- 10-year CVD risk equal or lower than 10% according to "SCORE"
Key exclusion criteria (13 listed)
- Pregnant or having the wish to become pregnant, or lactating
- Use of prescribed medication which may interfere with study measurements
- Use of antibiotics in the 3 months before screening or during the study
- Use of any medically- or self-prescribed diet with the purpose to reduce weight
- Intolerance for gluten or lactose
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 sterols and fish oil4 weeks intervention, 3 times daily | Dietary supplement | Dose 1, Dose 2, Dose 3 |
| Plant sterols4 weeks intervention, 3 times daily | Dietary supplement | Control |
| Placebo4 weeks, 3 times daily | Dietary supplement | Placebo |
Primary outcome
Change in blood lipid profile
Time frame: At baseline (after 4 weeks run-in period) and after 4 weeks intervention
Includes total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides
2 secondary outcomes
Change in EPA/DHA in red blood cells
Time frame: At baseline (after 4 weeks run-in period) and after 4 weeks intervention
Change in metabolomic parameters
Time frame: At baseline (after 4 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 7 Feb 2012.
- Derived from this study: PubMed 25122648Ras RT, Demonty I, Zebregs YE, Quadt JF, Olsson J, Trautwein EA. Low doses of eicosapentaenoic acid and docosahexaenoic acid from fish oil dose-dependently decrease serum triglyceride concentrations in the presence of plant sterols in hypercholesterolemic men and women. J Nutr. 2014 Oct;144(10):1564-70. doi: 10.3945/jn.114.192229. Epub 2014 Aug 13.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Johan Olsson, PhD principal investigator
KPL Good Food Practice AB
Birgitta Sundberg, PhD study director
KPL Good Food Practice AB
Anneli Hallmin study director
KPL Good Food Practice AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant sterols and fish oil and Plant sterols in people with Healthy and Mildly Elevated Cholesterol Levels, run by Unilever R&D at 1 site in Sweden.
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 12 inclusion and 13 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 7 Feb 2012. 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 Sweden. 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 blood lipid profile (time frame: At baseline (after 4 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 NCT01313988, 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 7 Feb 2012.