NCT01559428

Brief Summary

Plant sterols and stanols (also called phytosterols and phytostanols) are structurally related to cholesterol, but absorbed to a much lesser extent. Due to this structural similarity, plant sterols and stanols inhibit intestinal cholesterol absorption and lower serum LDL cholesterol concentrations by about 10% at daily intakes of 2.5 g. Plant sterol- and stanol-enriched food products are therefore widely available on the market to lower the risk for coronary heart disease. Plant sterols can undergo oxidation, which results in the formation of oxyphytosterols. Animal studies have now suggested that oxyphytosterols are atherogenic. Although oxyphytosterols have been identified in human serum samples, the effect of an increased intake of plant sterols on serum oxyphytosterol concentrations in humans is not known. On the other hand, plant stanols cannot be oxidized and lower not only cholesterol absorption, but also plant sterol absorption. The major objective of the present study is to examine the effects of dietary plant sterols and stanols on fasting serum concentrations of oxyphytosterols. The minor objective is to investigate the effects of these products on postprandial serum oxyphytosterol concentrations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2010

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, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2010

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 12, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 21, 2012

Completed
Last Updated

September 6, 2018

Status Verified

September 1, 2018

Enrollment Period

6 months

First QC Date

March 12, 2012

Last Update Submit

September 4, 2018

Conditions

Normocholesterolemic

Keywords

Plant sterolsPlant stanolsOxyphytosterolsCardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • Plasma oxyphytosterol concentrations

    Measured at baseline and after 4 weeks. Changes will be calculated between day 28 and day 0 of each intervention period.

Secondary Outcomes (4)

  • Serum plant sterol concentrations

    Measured at baseline and after 4 weeks. Changes will be calculated between day 28 and day 0 of each intervention period.

  • Serum lipoprotein concentrations

    Measured at baseline and after 3 and 4 weeks. Changes will be calculated between day 21+28 and day 0 of each intervention period.

  • Plasma glucose concentration

    Measured at day 28, on 13 time points

  • Markers reflecting low-grade inflammation and endothelial activation

    Measured at day 28, on 5 time points

Study Arms (3)

Plant sterol-enriched margarine

EXPERIMENTAL
Dietary Supplement: Plant sterol-enriched margarine

Plant stanol-enriched margarine

EXPERIMENTAL
Dietary Supplement: Plant stanol-enriched margarine

Control margarine

PLACEBO COMPARATOR
Dietary Supplement: Control margarine

Interventions

Plant sterol-enriched margarineDIETARY_SUPPLEMENT

Daily consumption of 20 gram of a plant sterol-enriched margarine (providing daily 3.0 gram of plant sterols), for a period of 4 weeks. At the end of the 4 weeks, subjects will undergo a postprandial test for 8 hours, in which 20 gram of the plant sterol-enriched margarine is consumed together with a high-fat milkshake

Plant sterol-enriched margarine
Plant stanol-enriched margarineDIETARY_SUPPLEMENT

Daily consumption of 20 gram of a plant stanol-enriched margarine (providing daily 3.0 gram of plant stanols), for a period of 4 weeks. At the end of the 4 weeks, subjects will undergo a postprandial test for 8 hours, in which 20 gram of the plant stanol-enriched margarine is consumed together with a high-fat milkshake

Plant stanol-enriched margarine
Control margarineDIETARY_SUPPLEMENT

Daily consumption of 20 gram of a control margarine, for a period of 4 weeks. At the end of the 4 weeks, subjects will undergo a postprandial test for 8 hours, in which 20 gram of the control margarine is consumed together with a high-fat milkshake

Control margarine

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body Mass Index (BMI) between 20-30 kg/m2
  • mean serum total cholesterol \< 7.8 mmol/L
  • mean serum triacylglycerol \< 3.0 mmol/L
  • mean plasma glucose \< 6.1 mmol/L

You may not qualify if:

  • unstable body weight (weight gain or loss \> 3 kg in the past two months)
  • active cardiovascular diseases like congestive heart failure or recent (\<6 months) event (acute myocardial infarction, cerebral vascular incident)
  • severe medical conditions that might interfere with the study such as epilepsy, asthma, chronic obstructive pulmonary disease, inflammatory bowel disease and rheumatoid arthritis
  • indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus
  • use of medication such as corticosteroids, diuretics or lipid lowering therapy
  • abuse of drug or alcohol (\>21 units per week)
  • not willing to stop the consumption of vitamin supplements, fish oil capsules or products rich in sterol or stanol esters 4 weeks before the start of the study (wash-in period)
  • use of an investigational product within another biomedical study within the previous month
  • pregnant or breast-feeding women
  • not willing to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study and during the study
  • current smoker
  • anemia. with a Hb-level below 7.5 mmol/L for men and below 7.0 mmol/L for women, as indicated by the blood bank of Maastricht

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Limburg, 6229 ER, Netherlands

Location

Related Publications (3)

  • Baumgartner S, Mensink RP, Plat J. Effects of a Plant Sterol or Stanol Enriched Mixed Meal on Postprandial Lipid Metabolism in Healthy Subjects. PLoS One. 2016 Sep 9;11(9):e0160396. doi: 10.1371/journal.pone.0160396. eCollection 2016.

    PMID: 27611192DERIVED

  • Baumgartner S, Mensink RP, den Hartog G, Bast A, Bekers O, Husche C, Lutjohann D, Plat J. Oxyphytosterol formation in humans: identification of high vs. low oxidizers. Biochem Pharmacol. 2013 Jul 1;86(1):19-25. doi: 10.1016/j.bcp.2013.02.035. Epub 2013 Mar 13.

    PMID: 23500537DERIVED

  • Baumgartner S, Mensink RP, Husche C, Lutjohann D, Plat J. Effects of plant sterol- or stanol-enriched margarine on fasting plasma oxyphytosterol concentrations in healthy subjects. Atherosclerosis. 2013 Apr;227(2):414-9. doi: 10.1016/j.atherosclerosis.2013.01.012. Epub 2013 Jan 21.

    PMID: 23375753DERIVED

Related Links

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Jogchum Plat, Dr.

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2012

First Posted

March 21, 2012

Study Start

May 1, 2010

Primary Completion

October 26, 2010

Study Completion

February 2, 2012

Last Updated

September 6, 2018

Record last verified: 2018-09

Locations

NL(1)