Lipid-lowering Effect of Plant Stanol Yogurt

The Cholesterol Lowering Efficacy of Plant Stanol Ester Yoghurt in a Turkish Population

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01882517

Enrollment

Registered

2013-06-20

Start date

2011-03-31

Completion date

2012-01-31

Last updated

2013-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia, Hyperlipidemias, Dyslipidemias

Brief summary

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

Interventions

DIETARY_SUPPLEMENTYogurt that contains plant stanol esters

DIETARY_SUPPLEMENTPlacebo yogurt

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* 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)

Exclusion criteria

* 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 * 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

Design outcomes

Primary

Measure	Time frame
Change in serum LDL cholesterol	4 weeks

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026