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OpenTrials
Completed

NCT Number: NCT01882517

Lipid-lowering Effect of Plant Stanol Yogurt

To determine the effect of investigational products on serum LDL cholesterol.

Completed

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, Turkey (Türkiye)

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 yogurt is less well known.

Study was monitored by Foodfiles

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yogurt that contains plant stanol esters

Dietary Supplement

Placebo yogurt

Dietary Supplement

Primary outcomes

  1. Change in serum LDL cholesterol

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Raisio Group

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 20, 2013
Registry last updated
Jun 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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