NCT00441857

Brief Summary

This study aims to measure the effect of three different doses of plant stanols in margarine on the cholesterol absorption efficiency in subjects with mildly to moderately increased serum LDL cholesterol concentrations

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_4

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 1, 2007

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

July 6, 2007

Status Verified

July 1, 2007

First QC Date

February 28, 2007

Last Update Submit

July 4, 2007

Conditions

Hypercholesterolemia

Keywords

plant sterolsplant stanolscholesterol absorption

Outcome Measures

Primary Outcomes (1)

  • cholesterol absorption efficiency

Secondary Outcomes (1)

  • changes in blood lipids

Interventions

plant stanol consumptionBEHAVIORAL

Eligibility Criteria

Age25 Years - 68 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy adults with mild to moderate hypercholesterolemia

You may not qualify if:

  • lipid lowering medication
  • pregnancy or lactation
  • severe diseases (inc. diabetes, unstable CVD, malignant diseases)
  • severe obesity
  • regular plant sterol consumption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oy Foodfiles Ltd

Kuopio, 70210, Finland

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Sakari A Nieminen, MD

    Oy Foodfiles Ltd

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 28, 2007

First Posted

March 1, 2007

Study Start

March 1, 2007

Study Completion

May 1, 2007

Last Updated

July 6, 2007

Record last verified: 2007-07

Locations

FI(1)