Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2010-01-31
2011-03-31
Brief Summary
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Detailed Description
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The aim of this study is to investigate the effects of plant stanol esters on serum lipid and lipoprotein lipid concentrations, plant sterol and cholestanol concentrations as well as cholesterol metabolism in T1 diabetics on statin use.
Altogether, twenty-four T1 diabetics (HbA1c \<9%) on stabile statin use will be recruited to the study from an announcement in the local newspaper and from Kuopio University Hospital and Harjula Hospital. The study is carried out with a randomized, double-blind and parallel design. The intervention group (n=12) consumes spread enriched with plant stanol esters (3 g/d stanols) and the control group (n=12) the same spread containing no added stanols for 4 weeks. The fasting blood samples are taken at weeks 0, 3 and 4. From blood samples concentrations of serum lipids, squalene and non-cholesterol sterols will be analyzed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Stanol ester spread
Vegetable oil based margarine with stanol ester enrichment
Vegetable oil based margarine with plant stanol ester enrichment
3 g plant stanols/ day
control spread
Vegetable oil based margarine without stanol ester enrichment
Vegetable oil based margarine with plant stanol ester enrichment
3 g plant stanols/ day
Interventions
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Vegetable oil based margarine with plant stanol ester enrichment
3 g plant stanols/ day
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
72 Years
ALL
No
Sponsors
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Kuopio University Hospital
OTHER
Raisio Plc
INDUSTRY
Marjukka Kolehmainen
OTHER
Responsible Party
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Marjukka Kolehmainen
Senior scientist
Principal Investigators
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Helena Gylling, Professor
Role: STUDY_DIRECTOR
University of Eastern Finland
Maarit Hallikainen, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Eastern Finland
Locations
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University of Eastern Finland
Kuopio, , Finland
Countries
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Other Identifiers
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125/2009
Identifier Type: -
Identifier Source: org_study_id
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