DyslipidemiasNCT02316808
Cholesterol-lowering Effects of Plant Stanol Ester
A study testing Plant stanol ester in people with Dyslipidemias and Hypercholesterolemia, run by Raisio Group.
Trial summary
Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented. LDL-cholesterol lowering efficacy of the ingredient administered in a smoothie is less well known. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias, Hypercholesterolemia, Hyperlipidemias
- What is being tested?
- Plant stanol ester
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Dec 2011
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- total cholesterol concentration ≥ 200 mg/dL and < 300 mg/dL, and or LDL-C concentration ≥ 130 mg/dL and < 180 mg/dL
- were willing to consume control or plant stanol ester smoothie drinks two bottles per day immediately after a meal for four weeks,
- reachable by phone
- willing to declare written informed consent
- agreed in accordance with data protective stipulations and readiness to participate in the trial and to adhere to the study conditions.
Who cannot join
- Pregnant women
- obese
- diabetic subjects or subjects with random plasma glucose concentration > 200 mg/dL
- hyperthyroidism, a history of metabolic, endocrine and kidney disorders
- acute or chronic severe diseases possibly interfering with the evaluation of the outcome of the clinical trial (such as AIDS, tumor diseases, malignant hypertension, cardiac insufficiency according to NYHA III-IV)
- taking lipid-lowering medication or other medications likely to affect lipid metabolism
About this study
Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented. LDL-cholesterol lowering efficacy of the ingredient administered in a smoothie is less well known.
- Conditions
- Dyslipidemias, Hypercholesterolemia, Hyperlipidemias
- Being tested
- Plant stanol ester, placebo
- Medical subject headings
- Dyslipidemias, Hypercholesterolemia, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant stanol esterDietary supplement
Smoothie that contains plant stanol ester
placeboDietary supplement
Smoothie that contains placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo smoothie | Placebo comparator | Not described Receives: Dietary Supplement: placebo |
| Plant stanol ester smoothie | Experimental | Not described Receives: Dietary Supplement: Plant stanol ester |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change (proportional) in LDL-C from baseline up to 4-weeks after plant stanol ester smoothie drink consumption.
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 posted15 Dec 2014 (estimated)
- Study startAug 2011
- Primary completionDec 2011
- Study completionDec 2011
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 DyslipidemiasStudies 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
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Raisio Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universitas Indonesia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316808
- Sponsor's protocol ID
- PCL_2011_Kal
- Status last verified
- Dec 2014
- First submitted
- 10 Dec 2014
- Last updated
- 23 Dec 2014
- Results posted
- No
Publications
Lestiani L, Chandra DN, Laitinen K, Ambarwati FD, Kuusisto P, Lukito W. Double-Blind Randomized Placebo Controlled Trial Demonstrating Serum Cholesterol Lowering Efficacy of a Smoothie Drink with Added Plant Stanol Esters in an Indonesian Population. Cholesterol. 2018 Feb 4;2018:4857473. doi: 10.1155/2018/4857473. eCollection 2018.
PubMed 29535869
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cholesterol-lowering Effects of Plant Stanol Ester
- ClinicalTrials.gov ID
- NCT02316808
- Acronym / sponsor ID
- PCL_2011_Kal
- Conditions
- Dyslipidemias, Hypercholesterolemia, Hyperlipidemias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Raisio GroupIndustry (pharma, biotech, devices)
- Collaborators
- Universitas Indonesia
- Study start
- Aug 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 15 Dec 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.
Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented. LDL-cholesterol lowering efficacy of the ingredient administered in a smoothie is less well known.
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 |
|---|---|---|
| Placebo smoothie | Placebo comparator | Dietary Supplement: placebo |
| Plant stanol ester smoothie | Experimental | Dietary Supplement: Plant stanol ester |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- total cholesterol concentration ≥ 200 mg/dL and < 300 mg/dL, and or LDL-C concentration ≥ 130 mg/dL and < 180 mg/dL
- were willing to consume control or plant stanol ester smoothie drinks two bottles per day immediately after a meal for four weeks,
- reachable by phone
- willing to declare written informed consent
- agreed in accordance with data protective stipulations and readiness to participate in the trial and to adhere to the study conditions.
Key exclusion criteria (6 listed)
- Pregnant women
- obese
- diabetic subjects or subjects with random plasma glucose concentration > 200 mg/dL
- hyperthyroidism, a history of metabolic, endocrine and kidney disorders
- acute or chronic severe diseases possibly interfering with the evaluation of the outcome of the clinical trial (such as AIDS, tumor diseases, malignant hypertension, cardiac insufficiency according to NYHA III-IV)
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 stanol esterSmoothie that contains plant stanol ester | Dietary supplement | Plant stanol ester smoothie |
| placeboSmoothie that contains placebo | Dietary supplement | Placebo smoothie |
Primary outcome
Change (proportional) in LDL-C from baseline up to 4-weeks after plant stanol ester smoothie drink consumption.
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 23 Dec 2014.
- Derived from this study: PubMed 29535869Lestiani L, Chandra DN, Laitinen K, Ambarwati FD, Kuusisto P, Lukito W. Double-Blind Randomized Placebo Controlled Trial Demonstrating Serum Cholesterol Lowering Efficacy of a Smoothie Drink with Added Plant Stanol Esters in an Indonesian Population. Cholesterol. 2018 Feb 4;2018:4857473. doi: 10.1155/2018/4857473. eCollection 2018.
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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 Plant stanol ester in people with Dyslipidemias and Hypercholesterolemia, 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 23 Dec 2014. 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?
Change (proportional) in LDL-C from baseline up to 4-weeks after plant stanol ester smoothie drink consumption. (time frame: 4 weeks). 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 NCT02316808, 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 23 Dec 2014.