HypercholesterolemiaNCT01882517
Lipid-lowering Effect of Plant Stanol Yogurt
A study testing Yogurt that contains plant stanol esters in people with Hypercholesterolemia and Hyperlipidemias, run by Raisio Group at 1 site in Turkey (Türkiye).
Trial summary
To determine the effect of investigational products on serum LDL cholesterol. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia, Hyperlipidemias, Dyslipidemias
- What is being tested?
- Yogurt that contains plant stanol esters
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- subjects must voluntarily sign the informed consent
- subjects must be male or female aged 20 to 70 years
- subjects must have a serum total cholesterol concentration of 5.2 - 7.5 mmol/l ( 205 - 290 mg/dl) at the screening visit (visit 1, -2 week)
Who cannot join
- subjects using lipid lowering medication
- subjects using ezetimibe
- subjects with bile acid sequestrant medication
- subjects with statin therapy
- subjects using other medication significantly influencing on lipid values
- subjects with diagnosis type 1 or type 2 diabetes
Show all 19Show fewer
- severe obesity (BMI>35.0 kg/m2)
- serum fasting triglycerides > 4.0 mmol/l
- subjects with any hepatic or renal disorder according to medical history
- subjects who have history of myocardial infarction or unstable angina pectoris within six months prior to screening
- subjects who have history of coronary artery bypass graft or percutaneous transluminal coronary angioplasty within six months prior to screening
- subjects who have history of temporal ischemic attack or stroke within six months prior to screening
- subjects who have a history of cancer or other malignant disease within the past five years
- subjects with abnormal values of health screening variables measured at screening visit: serum gamma-glutamyltransferase> 2 x upper limit, serum alkaline phosphatase> 2 x upper limit or other abnormality in laboratory evaluations considered as clinically significant in the opinion of the study physician
- subjects who are consuming more than 15 portions of alcohol / week
- subjects who are pregnant or lactating
- subjects using Benecol, Becelpro.activ, Danacol or other plant sterol enriched products within 30 days before visit 2
- subjects with severe lactose intolerance, milk allergy or any other intolerance to the ingredients of test products
- celiac disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Cholesterol Lowering Efficacy of Plant Stanol Ester Yoghurt in a Turkish Population
To determine the effect of investigational products on serum LDL cholesterol.
Read the detailed description
Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented. LDL-cholesterol lowering efficacy of the ingredient administered in a yogurt is less well known.
Study was monitored by Foodfiles
- Conditions
- Hypercholesterolemia, Hyperlipidemias, Dyslipidemias
- Being tested
- Yogurt that contains plant stanol esters, Placebo yogurt
- 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.
Yogurt that contains plant stanol estersDietary supplement
Placebo yogurtDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Yogurt that contains plant stanol esters | Active comparator | Dietary Supplement: Yogurt that contains plant stanol esters Receives: Dietary Supplement: Yogurt that contains plant stanol esters |
| Placebo yogurt | Placebo comparator | Dietary Supplement: Placebo yogurt Receives: Dietary Supplement: Placebo yogurt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum LDL cholesterol
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 posted20 Jun 2013 (estimated)
- Study startMar 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.
- 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Raisio Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01882517
- Sponsor's protocol ID
- PCL_2010_024
- Status last verified
- Jun 2013
- First submitted
- 18 Jun 2013
- Last updated
- 20 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cholesterol Lowering Efficacy of Plant Stanol Ester Yoghurt in a Turkish Population
- ClinicalTrials.gov ID
- NCT01882517
- Acronym / sponsor ID
- PCL_2010_024
- Conditions
- Hypercholesterolemia, Hyperlipidemias, Dyslipidemias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Raisio GroupIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 20 Jun 2013 (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.
To determine the effect of investigational products on serum LDL cholesterol.
Detailed description
Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented. LDL-cholesterol lowering efficacy of the ingredient administered in a yogurt is less well known.
Study was monitored by Foodfiles
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 |
|---|---|---|
| Yogurt that contains plant stanol esters | Active comparator | Dietary Supplement: Yogurt that contains plant stanol estersDietary Supplement: Yogurt that contains plant stanol esters |
| Placebo yogurt | Placebo comparator | Dietary Supplement: Placebo yogurtDietary Supplement: Placebo yogurt |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- subjects must voluntarily sign the informed consent
- subjects must be male or female aged 20 to 70 years
- subjects must have a serum total cholesterol concentration of 5.2 - 7.5 mmol/l ( 205 - 290 mg/dl) at the screening visit (visit 1, -2 week)
Key exclusion criteria (19 listed)
- subjects using lipid lowering medication
- subjects using ezetimibe
- subjects with bile acid sequestrant medication
- subjects with statin therapy
- subjects using other medication significantly influencing on lipid values
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 |
|---|---|---|
| Yogurt that contains plant stanol esters | Dietary supplement | Yogurt that contains plant stanol esters |
| Placebo yogurt | Dietary supplement | Placebo yogurt |
Primary outcome
Change in serum LDL cholesterol
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 20 Jun 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yogurt that contains plant stanol esters in people with Hypercholesterolemia and Hyperlipidemias, run by Raisio Group at 1 site in Turkey (Türkiye).
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 3 inclusion and 19 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 20 Jun 2013. 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 Turkey (Türkiye). 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 serum LDL cholesterol (time frame: 4 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 20 Jun 2013.