HypercholesterolemiaNCT02628990
Lipid-lowering Effect of Plant Stanol Ester Yoghurt Drinks
A study testing 1.6 g plant stanols, 2 g plant stanols and 1.6 g plant stanols and camelina oil in people with Hypercholesterolemia and Hyperlipidemias, run by Raisio Group.
Trial summary
The aim is to investigate the effects of yoghurt drinks containing two doses of plant stanol ester either with or without added camelina oil on the serum cholesterol levels in moderately hypercholesterolemic subjects Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia, Hyperlipidemias, Dyslipidemias
- What is being tested?
- 1.6 g plant stanols, 2 g plant stanols and 1.6 g plant stanols and camelina oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 155 participants
- Where
- No sites listed yet
- Study dates
- Jun 2005to Nov 2005
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI < 30 kg/m2
- moderate hypercholesterolemia (fasting total cholesterol between 5-8 mmol/l)
- serum triglycerides < 3 mmol/l.
- normal liver, kidney and thyroid function
- subjects must voluntarily sign the informed consent
Who cannot join
- use of cholesterol lowering foods or dietary supplements within 21 days before the start of the intervention
- lipid lowering medication
- history of unstable coronary artery disease (myocardial infarction, coronary artery bypass craft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months, diabetes, hyperglycemia, temporal ischemic attack and malignant diseases
- pregnancy or lactation
- alcohol abuse
- subjects with intolerance to any ingredient of the test products
About this study
Official title: The Effect of Plant Stanol Ester Yoghurt Drinks With or Without Added Camelina Oil on Serum Lipids in Comparison to Placebo in Subjects With Mildly to Moderately Elevated Serum Cholesterol Concentrations
The aim is to investigate the effects of yoghurt drinks containing two doses of plant stanol ester either with or without added camelina oil on the serum cholesterol levels in moderately hypercholesterolemic subjects
- Conditions
- Hypercholesterolemia, Hyperlipidemias, Dyslipidemias
- Being tested
- 1.6 g plant stanols, 2 g plant stanols, 1.6 g plant stanols and camelina oil, 2 g plant stanols and camelina oil, Placebo
- Medical subject headings
- Hypercholesterolemia, Hyperlipidemias, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.6 g plant stanolsOther
Lipid-lowering effect of Yoghurt Drink with 1.6 g plant stanols
2 g plant stanolsOther
Lipid-lowering effect of Yoghurt Drink with 2 g plant stanols
1.6 g plant stanols and camelina oilOther
Lipid-lowering effect of Yoghurt Drink with 1.6 g plant stanols and camelina oil
2 g plant stanols and camelina oilOther
Lipid-lowering effect of Yoghurt Drink with 2 g plant stanols and camelina oil
PlaceboOther
Lipid-lowering effect of Placebo Yoghurt Drink
| Study group | Role | What they receive |
|---|---|---|
| 1.6 g plant stanols | Experimental | A yoghurt drink containing plant stanol ester (1.6 grams plant stanols), consumed with a meal daily for 4 weeks Receives: Other: 1.6 g plant stanols |
| 2 g plant stanols | Experimental | A yoghurt drink containing plant stanol ester (2 grams plant stanols), consumed with a meal daily for 4 weeks Receives: Other: 2 g plant stanols |
| 1.6 g plant stanols and camelina oil | Experimental | A yoghurt drink containing plant stanol ester (1.6 grams plant stanols) and camelina oil (2 g), consumed with a meal daily for 4 weeks Receives: Other: 1.6 g plant stanols and camelina oil |
| 2 g plant stanols and camelina oil | Experimental | A yoghurt drink containing plant stanol ester (2 grams plant stanols) and camelina oil (2 g), consumed with a meal daily for 4 weeks Receives: Other: 2 g plant stanols and camelina oil |
| Placebo | Placebo comparator | A placebo yoghurt drink, consumed with a meal daily for 4 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentual change in serum LDL-cholesterol
Percentual change [end of intervention - start of intervention] in serum LDL-cholesterol between experimental and placebo groups
Measured: 4 weeks
Absolute change in serum LDL-cholesterol
Absolute change [end of intervention - start of intervention] in serum LDL-cholesterol between experimental and placebo groups, mmol/l
Measured: 4 weeks
Secondary outcomes (6)
Percentual change in serum total cholesterol
Percentual change [end of intervention - start of intervention] in serum total cholesterol between experimental and placebo groups
Measured: 4 weeks
Absolute change in serum total cholesterol
Absolute change [end of intervention - start of intervention] in serum total cholesterol between experimental and placebo groups, mmol/l
Measured: 4 weeks
Percentual change in serum non-HDL cholesterol
Percentual change [end of intervention - start of intervention] in serum nonHDL cholesterol between experimental and placebo groups
Measured: 4 weeks
Absolute change in serum non-HDL cholesterol
Absolute change [end of intervention - start of intervention] in serum nonHDL cholesterol between experimental and placebo groups, mmol/l
Measured: 4 weeks
Percentual change in serum triglycerides
Percentual change [end of intervention - start of intervention] in serum triglycerides between experimental and placebo groups
Measured: 4 weeks
Absolute change in serum triglycerides
Absolute change [end of intervention - start of intervention] in serum triglycerides between experimental and placebo groups, mmol/l
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startJun 2005
- Primary completionAug 2005
- Study completionNov 2005
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 HypercholesterolemiaStudies 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
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Raisio Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Turku
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02628990
- Sponsor's protocol ID
- YD2005
- Status last verified
- Dec 2015
- First submitted
- 1 Dec 2015
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Salo P, Kuusisto P. Cholesterol Lowering Effect of Plant Stanol Ester Yoghurt Drinks with Added Camelina Oil. Cholesterol. 2016;2016:5349389. doi: 10.1155/2016/5349389. Epub 2016 Feb 21.
PubMed 26998355
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Plant Stanol Ester Yoghurt Drinks With or Without Added Camelina Oil on Serum Lipids in Comparison to Placebo in Subjects With Mildly to Moderately Elevated Serum Cholesterol Concentrations
- ClinicalTrials.gov ID
- NCT02628990
- Acronym / sponsor ID
- YD2005
- Conditions
- Hypercholesterolemia, Hyperlipidemias, Dyslipidemias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Raisio GroupIndustry (pharma, biotech, devices)
- Collaborators
- University of Turku
- Study start
- Jun 2005
- Primary completion
- Aug 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 11 Dec 2015 (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 aim is to investigate the effects of yoghurt drinks containing two doses of plant stanol ester either with or without added camelina oil on the serum cholesterol levels in moderately hypercholesterolemic subjects
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 |
|---|---|---|
| 1.6 g plant stanols | Experimental | Other: 1.6 g plant stanolsA yoghurt drink containing plant stanol ester (1.6 grams plant stanols), consumed with a meal daily for 4 weeks |
| 2 g plant stanols | Experimental | Other: 2 g plant stanolsA yoghurt drink containing plant stanol ester (2 grams plant stanols), consumed with a meal daily for 4 weeks |
| 1.6 g plant stanols and camelina oil | Experimental | Other: 1.6 g plant stanols and camelina oilA yoghurt drink containing plant stanol ester (1.6 grams plant stanols) and camelina oil (2 g), consumed with a meal daily for 4 weeks |
| 2 g plant stanols and camelina oil | Experimental | Other: 2 g plant stanols and camelina oilA yoghurt drink containing plant stanol ester (2 grams plant stanols) and camelina oil (2 g), consumed with a meal daily for 4 weeks |
| Placebo | Placebo comparator | Other: PlaceboA placebo yoghurt drink, consumed with a meal daily for 4 weeks |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI < 30 kg/m2
- moderate hypercholesterolemia (fasting total cholesterol between 5-8 mmol/l)
- serum triglycerides < 3 mmol/l.
- normal liver, kidney and thyroid function
- subjects must voluntarily sign the informed consent
Key exclusion criteria (6 listed)
- use of cholesterol lowering foods or dietary supplements within 21 days before the start of the intervention
- lipid lowering medication
- history of unstable coronary artery disease (myocardial infarction, coronary artery bypass craft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months, diabetes, hyperglycemia, temporal ischemic attack and malignant diseases
- pregnancy or lactation
- alcohol abuse
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 |
|---|---|---|
| 1.6 g plant stanolsLipid-lowering effect of Yoghurt Drink with 1.6 g plant stanols | Other | 1.6 g plant stanols |
| 2 g plant stanolsLipid-lowering effect of Yoghurt Drink with 2 g plant stanols | Other | 2 g plant stanols |
| 1.6 g plant stanols and camelina oilLipid-lowering effect of Yoghurt Drink with 1.6 g plant stanols and camelina oil | Other | 1.6 g plant stanols and camelina oil |
| 2 g plant stanols and camelina oilLipid-lowering effect of Yoghurt Drink with 2 g plant stanols and camelina oil | Other | 2 g plant stanols and camelina oil |
| PlaceboLipid-lowering effect of Placebo Yoghurt Drink | Other | Placebo |
Primary outcome
Percentual change in serum LDL-cholesterol
Time frame: 4 weeks
Percentual change [end of intervention - start of intervention] in serum LDL-cholesterol between experimental and placebo groups
Absolute change in serum LDL-cholesterol
Time frame: 4 weeks
Absolute change [end of intervention - start of intervention] in serum LDL-cholesterol between experimental and placebo groups, mmol/l
6 secondary outcomes
Percentual change in serum total cholesterol
Time frame: 4 weeks
Absolute change in serum total cholesterol
Time frame: 4 weeks
Percentual change in serum non-HDL cholesterol
Time frame: 4 weeks
Absolute change in serum non-HDL cholesterol
Time frame: 4 weeks
Percentual change in serum triglycerides
Time frame: 4 weeks
Absolute change in serum triglycerides
Time frame: 4 weeks
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 11 Dec 2015.
- Derived from this study: PubMed 26998355Salo P, Kuusisto P. Cholesterol Lowering Effect of Plant Stanol Ester Yoghurt Drinks with Added Camelina Oil. Cholesterol. 2016;2016:5349389. doi: 10.1155/2016/5349389. Epub 2016 Feb 21.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 1.6 g plant stanols, 2 g plant stanols and 1.6 g plant stanols and camelina oil in people with Hypercholesterolemia and Hyperlipidemias, run by Raisio Group.
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 5 inclusion and 6 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 11 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Percentual change in serum LDL-cholesterol (time frame: 4 weeks). 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 NCT02628990, 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 11 Dec 2015; AzTrials last refreshed its copy on 6 Nov 2026.