HypercholesterolemiaNCT05064644
Lipid Lowering Effect of Plant Stanol Ester in a Spoonable Non-dairy Product
A study testing Product that contains plant stanol ester in people with Hypercholesterolemia, run by Raisio Group at 1 site in Finland.
Trial summary
The aim is to determine the effect of investigational products on serum LDL cholesterol. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Product that contains plant stanol ester
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteFinland
- Study dates
- 1 Aug 2021to 30 Nov 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed written informed consent
- Mildly or moderately elevated plasma cholesterol levels (plasma total cholesterol 5.5-8.0 mmol/l)
- Plasma triglyceride levels ≤ 4.0 mmol/l
- Age 18-65 years
Who cannot join
- Intolerance to oats or other ingredients of the test products
- Severe obesity (BMI ≥ 32 kg/m2)
- Consumption of lipid/cholesterol lowering medication (e.g. ezetimibe, PCSK9 inhibitors, resins, fibrates) 1 month prior to the screening visit and throughout the study. Statin treatment is allowed at stable dose.
- Consumption of plant stanol or plant sterol containing food products or supplements such as Benecol, Becel pro.active, Keiju Alentaja or other foods or supplements such as beta-glucan enriched foods, red rice, berberine or any combination of these used for cholesterol lowering purpose 1 month prior the study entry (baseline blood sample)
- History of malignant diseases like cancer within five years prior to recruitment
- History of unstable coronary artery disease (myocardial infarction, coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months
Show all 13Show fewer
- Diagnosed type 1 or type 2 diabetes requiring medical treatment
- Celiac disease
- Medically prescribed diet/treatment for slimming or a special diet like very low calorie diet or use of prescribed an obesity drug (e.g. Orlistat, Victoza)
- Alcohol abuse (> 4 portion/per day) or recreational drug abuse
- Pregnancy or planned pregnancy or lactating
- Clinically significant abnormalities in screening labs
- Participation in another clinical trial in the preceding 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lipid Lowering Effect of Plant Stanol Ester in Oat-based, Fermented Spoonable Dairy Analogue -a 3-week Randomized, Double-blind, Placebo-controlled, Parallel-group Intervention Study
The aim is to determine the effect of investigational products on serum LDL cholesterol.
- Conditions
- Hypercholesterolemia
- Being tested
- Product that contains plant stanol ester, Placebo product
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Product that contains plant stanol esterOther
Product with active ingredient
Placebo productOther
Product without active ingredient
| Study group | Role | What they receive |
|---|---|---|
| Plant stanol ester comparator | Active comparator | Product that contains plant stanol ester Receives: Other: Product that contains plant stanol ester |
| Placebo comparator | Placebo comparator | Placebo product Receives: Other: Placebo product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LDL cholesterol concentration (%)
Mean relative change in serum LDL cholesterol concentration during the intervention
Measured: 0 vs 3 weeks
Secondary outcomes (6)
LDL cholesterol concentration
Mean absolute change in serum LDL cholesterol concentration during the intervention between test and control group
Measured: 0 vs 3 weeks
total cholesterol concentration
Changes in serum total cholesterol concentration during the intervention
Measured: 0 vs 3 weeks
HDL cholesterol concentration
Changes in serum HDL cholesterol concentration during the intervention
Measured: 0 vs 3 weeks
non-HDL cholesterol concentration
Changes in serum non-HDL cholesterol concentration during the intervention
Measured: 0 vs 3 weeks
Total triglyceride concentration
Changes in serum triglycerides concentrations
Measured: 0 vs 3 weeks
NMR blood biomarkers
Changes in specific NMR blood biomarkers
Measured: 0 vs 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start1 Aug 2021
- Primary completion30 Oct 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Raisio Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Helena Gylling, MD, Principal investigator, Helsinki University Hospital, Helsinki, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064644
- Sponsor's protocol ID
- NGH1
- Status last verified
- Dec 2021
- First submitted
- 10 Sep 2021
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipid Lowering Effect of Plant Stanol Ester in Oat-based, Fermented Spoonable Dairy Analogue -a 3-week Randomized, Double-blind, Placebo-controlled, Parallel-group Intervention Study
- ClinicalTrials.gov ID
- NCT05064644
- Acronym / sponsor ID
- NGH1
- Conditions
- Hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Raisio GroupIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 1 Oct 2021 (actual)
- 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 determine the effect of investigational products on serum LDL cholesterol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plant stanol ester comparator | Active comparator | Other: Product that contains plant stanol esterProduct that contains plant stanol ester |
| Placebo comparator | Placebo comparator | Other: Placebo productPlacebo product |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed written informed consent
- Mildly or moderately elevated plasma cholesterol levels (plasma total cholesterol 5.5-8.0 mmol/l)
- Plasma triglyceride levels ≤ 4.0 mmol/l
- Age 18-65 years
Key exclusion criteria (13 listed)
- Intolerance to oats or other ingredients of the test products
- Severe obesity (BMI ≥ 32 kg/m2)
- Consumption of lipid/cholesterol lowering medication (e.g. ezetimibe, PCSK9 inhibitors, resins, fibrates) 1 month prior to the screening visit and throughout the study. Statin treatment is allowed at stable dose.
- Consumption of plant stanol or plant sterol containing food products or supplements such as Benecol, Becel pro.active, Keiju Alentaja or other foods or supplements such as beta-glucan enriched foods, red rice, berberine or any combination of these used for cholesterol lowering purpose 1 month prior the study entry (baseline blood sample)
- History of malignant diseases like cancer within five years prior to recruitment
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 |
|---|---|---|
| Product that contains plant stanol esterProduct with active ingredient | Other | Plant stanol ester comparator |
| Placebo productProduct without active ingredient | Other | Placebo comparator |
Primary outcome
Change in LDL cholesterol concentration (%)
Time frame: 0 vs 3 weeks
Mean relative change in serum LDL cholesterol concentration during the intervention
6 secondary outcomes
LDL cholesterol concentration
Time frame: 0 vs 3 weeks
total cholesterol concentration
Time frame: 0 vs 3 weeks
HDL cholesterol concentration
Time frame: 0 vs 3 weeks
non-HDL cholesterol concentration
Time frame: 0 vs 3 weeks
Total triglyceride concentration
Time frame: 0 vs 3 weeks
NMR blood biomarkers
Time frame: 0 vs 3 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 3 Dec 2021.
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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.
Helena Gylling, MD principal investigator
Helsinki University Hospital, Helsinki, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Product that contains plant stanol ester in people with Hypercholesterolemia, run by Raisio Group at 1 site in Finland.
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 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 3 Dec 2021. 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 Finland. 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 LDL cholesterol concentration (%) (time frame: 0 vs 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2021.