search
Back to results

Plant Stanols and Type 1 Diabetes

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Vegetable oil based margarine with plant stanol ester enrichment
Sponsored by
Marjukka Kolehmainen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Plant stanols, type 1 diabetes, sterol metabolism, cholesterol

Eligibility Criteria

18 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • type 1 diabetes, stabile statin drug use, HbA1c <9%

Exclusion Criteria:

  • liver, kidney and thyroid dysfunction, severe diabetic proteinuria, gastroparesis, unstable CAD, unstable inflammatory gastrointestinal disease

Sites / Locations

  • University of Eastern Finland

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Stanol ester spread

control spread

Arm Description

Vegetable oil based margarine with stanol ester enrichment

Vegetable oil based margarine without stanol ester enrichment

Outcomes

Primary Outcome Measures

serum lipids
serum lipids
serum lipids
squalene
squalene
squalene
non-cholesterol sterols
non-cholesterol sterols
non-cholesterol sterols

Secondary Outcome Measures

Full Information

First Posted
September 13, 2010
Last Updated
April 16, 2012
Sponsor
Marjukka Kolehmainen
Collaborators
Kuopio University Hospital, Raisio Plc
search

1. Study Identification

Unique Protocol Identification Number
NCT01205308
Brief Title
Plant Stanols and Type 1 Diabetes
Official Title
Effects of Plant Stanol Esters on Serum Lipids, Precursors of Cholesterol Synthesis and Plant Sterols in Type 1 Diabetics on Stabile Statin Drug Use
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marjukka Kolehmainen
Collaborators
Kuopio University Hospital, Raisio Plc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In type 1 diabetes (T1D) coronary artery disease (CAD) is an important cause of morbidity and mortality. Although serum cholesterol concentrations are not always elevated in T1D, cholesterol metabolism is different from non-diabetics, so that cholesterol absorption is enhanced. 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. The study will give new information about how addition of plant stanol esters on statin use improve hypolipidemic effects in type 1 diabetes.
Detailed Description
In type 1 diabetes (T1D) coronary artery disease (CAD) is an important cause of morbidity and mortality. Although serum cholesterol concentrations are not always elevated in T1D, cholesterol metabolism is different from non-diabetics, so that cholesterol absorption is enhanced. Thus, theoretically, the best way to reduce serum cholesterol concentrations is to reduce cholesterol absorption. However, statins are recommended to T1 diabetics at the same LDL cholesterol levels as for type 2 diabetics to reduce risk to CAD. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Plant stanols, type 1 diabetes, sterol metabolism, cholesterol

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stanol ester spread
Arm Type
Active Comparator
Arm Description
Vegetable oil based margarine with stanol ester enrichment
Arm Title
control spread
Arm Type
Placebo Comparator
Arm Description
Vegetable oil based margarine without stanol ester enrichment
Intervention Type
Dietary Supplement
Intervention Name(s)
Vegetable oil based margarine with plant stanol ester enrichment
Intervention Description
3 g plant stanols/ day
Primary Outcome Measure Information:
Title
serum lipids
Time Frame
Week 0
Title
serum lipids
Time Frame
Week 3
Title
serum lipids
Time Frame
Week 4
Title
squalene
Time Frame
Week 0
Title
squalene
Time Frame
Week 3
Title
squalene
Time Frame
Week 4
Title
non-cholesterol sterols
Time Frame
Week 0
Title
non-cholesterol sterols
Time Frame
Week 3
Title
non-cholesterol sterols
Time Frame
Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: type 1 diabetes, stabile statin drug use, HbA1c <9% Exclusion Criteria: liver, kidney and thyroid dysfunction, severe diabetic proteinuria, gastroparesis, unstable CAD, unstable inflammatory gastrointestinal disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helena Gylling, Professor
Organizational Affiliation
University of Eastern Finland
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Maarit Hallikainen, PhD
Organizational Affiliation
University of Eastern Finland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Eastern Finland
City
Kuopio
ZIP/Postal Code
FIN-70211
Country
Finland

12. IPD Sharing Statement

Learn more about this trial

Plant Stanols and Type 1 Diabetes

We'll reach out to this number within 24 hrs