CClinicalTrials.gg
CompletedNCT01882517Updated Jun 20, 2013

Lipid-lowering Effect of Plant Stanol Yogurt

An interventional study of Yogurt that contains plant stanol esters and Placebo yogurt in Hypercholesterolemia, Hyperlipidemias and Dyslipidemias, sponsored by Raisio Group. Completed at 1 site in Turkey. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-20.

Sponsored by Raisio Group · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Hypercholesterolemia
  • Hyperlipidemias
  • Dyslipidemias
03

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.

This study's enrollment of 70 is below the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

Raisio Group is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
70 participants (actual)

Study arms

  • Active comparator
    Yogurt that contains plant stanol esters

    Dietary Supplement: Yogurt that contains plant stanol esters

    Dietary Supplement: Yogurt that contains plant stanol esters

  • Placebo comparator
    Placebo yogurt

    Dietary Supplement: Placebo yogurt

    Dietary Supplement: Placebo yogurt

Interventions

  • Dietary supplementYogurt that contains plant stanol esters
  • Dietary supplementPlacebo yogurt
06

What researchers measure

Primary outcomes

  1. Change in serum LDL cholesterol

    Time frame: 4 weeks

07

Study locations

1 site
  • Hacettepe University
    Ankara, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 20, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01882517
Lead sponsor
Raisio Group
Responsible party
Sponsor
First posted
Jun 20, 2013
Start date
Mar 2011
Primary completion
Jan 2012
Completion
Jan 2012
Last update
Jun 20, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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