CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
plant stanol esterdietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01315964
NCT01315964N/ACompleted

Effects of Dietary Plant Stanol Esters of Blood Flow Among Healthy Adult Human Subject. The BLOOD FLOW -Study

University of Helsinki·interventional·Posted Mar 16, 2011·Updated Aug 28, 2013

In Brief

A clinical study evaluating plant stanol ester for Atherosclerosis. Completed, enrolled 100 participants across 1 site.

Detailed Summary

Plant stanol esters as part of daily diet can decrease serum level of LDL-cholesterol up to 10%. This decrease diminishes the risk of development of premature atherosclerosis and it´s complications (e.g., acute myocardial infarction) in adult human subjects. The purpose of the present study is to evaluate among healthy human subjects (N=100) effects of plant stanol esters (3 grams/day for 6 months) as part of daily diet in margarine on arterial endothelial cells, arterial stiffness, autonomic innervation of the arteries, arterial blood flow and serum fats. The non-invasive arterial measurements (VaSera®, EndoPat® and WinCRPS®) are performed and blood samples are taken at the beginning and at the end of the 6-month-long study period. Also questionnaires concerning healthy, and life and dietary habits are fulfilled. Dietary records (twice for a 3-day-period) are done. Hypothesis of the study is that a dietary serum cholesterol lowering intervention has beneficial influence on the early prognostic markers of premature atherosclerosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtherosclerosis
CountriesFinland

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 16, 2011
Enrollment StartFeb 1, 2011
Primary CompletionDec 1, 2011
Study CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 15.3 years ago

Interventions

plant stanol esterdietary

3 gr of plant stanol esters per day in a margarine product as part of daily diet for a period of 6 months