NCT00928616

Brief Summary

The purpose of this study is to evaluate the effects of a diet supplementation with plant sterol esters on serum lipids, plant sterol concentrations and monocyte subpopulations.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 26, 2009

Completed
Last Updated

June 26, 2009

Status Verified

June 1, 2009

Enrollment Period

2 months

First QC Date

June 25, 2009

Last Update Submit

June 25, 2009

Conditions

Hyperlipidemia

Keywords

hyperlipidemiaplant sterolsmonocytes

Outcome Measures

Primary Outcomes (1)

  • monocyte subpopulations

    4 weeks

Secondary Outcomes (1)

  • serum parameters (lipids, plant sterol concentrations, inflammation parameters)

    4 weeks

Study Arms (2)

plant sterol esters

EXPERIMENTAL

Participants consume plant sterol ester supplemented margarine (3 g/day)

Dietary Supplement: margarine + plant sterol esters

Placebo

PLACEBO COMPARATOR

Placebo is a non-sterol ester supplemented margarine

Dietary Supplement: margarine (placebo)

Interventions

margarine + plant sterol estersDIETARY_SUPPLEMENT

margarine supplemented with plant sterol esters (3g/day) over the time period of 4 weeks

Also known as: plant sterols
plant sterol esters
margarine (placebo)DIETARY_SUPPLEMENT

non-sterol ester supplemented margarine

Also known as: regular margarine
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy individuals without known cardiovascular diseases

You may not qualify if:

  • drugs that interfere with cholesterol metabolism
  • other use of dietary supplements
  • vegetarianism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III

Homburg, Saarland, 66421, Germany

Location

MeSH Terms

Conditions

Hyperlipidemias

Interventions

MargarinePhytosterols

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary FatsFatsLipidsDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesSterolsCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsMembrane LipidsPhytochemicalsBiological Factors

Study Officials

  • Oliver Weingärtner, MD

    Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 25, 2009

First Posted

June 26, 2009

Study Start

April 1, 2009

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

June 26, 2009

Record last verified: 2009-06

Locations

DE(1)