NCT00737919

Brief Summary

This study aims to explore whether the increased supply of dietary plant sterols and plant stanols have any influence on serum levels of phytosterols and on consistency of carotid atheromatous plaques.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

February 10, 2011

Status Verified

August 1, 2008

Enrollment Period

3.6 years

First QC Date

August 19, 2008

Last Update Submit

February 9, 2011

Conditions

Atherosclerosis

Keywords

CholesterolPlant sterolsAtherosclerotic carotid plaques

Outcome Measures

Primary Outcomes (1)

  • Sterols in serum and carotid plaques at the operation

    at operation and one month after operation

Study Arms (2)

1

ACTIVE COMPARATOR

A group of subjects consuming daily 2 grams of plant stanols 4-6 weeks before the operation

Dietary Supplement: Plant Stanol

2

ACTIVE COMPARATOR

A group of patients consuming daily 2 grams of plant sterols 4-6 weeks before the operation

Dietary Supplement: Plant Sterol

Interventions

Plant StanolDIETARY_SUPPLEMENT

Plant stanols in margarines daily 2 grams

1
Plant SterolDIETARY_SUPPLEMENT

Plant sterols in margarines daily 2 grams

2

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Asymptomatic tight carotid plaques
  • Age 40-80

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Div. of Vascular Surgery, Helsinki University Central Hospital

Helsinki, 00029, Finland

Location

MeSH Terms

Conditions

Atherosclerosis

Interventions

SitosterolsPhytosterols

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsMembrane LipidsLipidsPhytochemicalsBiological Factors

Study Officials

  • Tatu A. Miettinen, professor

    Dept. of Medicine, Div. of Internal Medicine, Helsinki Univ. Central Hospital, Biomedicum Helsinki

    PRINCIPAL INVESTIGATOR

  • Helena Gylling, Professor

    Department of Clinical Nutrition, University of Kuopio and Kuopion University Central Hospital, Kuopio, Finland

    PRINCIPAL INVESTIGATOR

  • Markku J Nissinen, MD, PhD

    Dept. of Medicine, Div. of Gastroenterology, HUCH, Helsinki, Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 19, 2008

First Posted

August 20, 2008

Study Start

May 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

February 10, 2011

Record last verified: 2008-08

Locations

FI(1)