Phytosterols and Oxyphytosterol Concentrations

September 4, 2018 updated by: Maastricht University Medical Center

The Effects of Plant Sterol and Stanol Esters on Serum Oxyphytosterol Concentrations in Healthy Human Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 ER
        • Maastricht University Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Plant stanol-enriched margarine
Dietary supplement: Plant stanol-enriched margarine
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
Experimental: Plant sterol-enriched margarine
Dietary supplement: Plant sterol-enriched margarine
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
Placebo Comparator: Control margarine
Dietary supplement: Control margarine
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma oxyphytosterol concentrations
Time Frame: Measured at baseline and after 4 weeks. Changes will be calculated between day 28 and day 0 of each intervention period.
Measured at baseline and after 4 weeks. Changes will be calculated between day 28 and day 0 of each intervention period.

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum plant sterol concentrations
Time Frame: Measured at baseline and after 4 weeks. Changes will be calculated between day 28 and day 0 of each intervention period.
Measured at baseline and after 4 weeks. Changes will be calculated between day 28 and day 0 of each intervention period.
Serum lipoprotein concentrations
Time Frame: Measured at baseline and after 3 and 4 weeks. Changes will be calculated between day 21+28 and day 0 of each intervention period.
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
Time Frame: Measured at day 28, on 13 time points
Measured at day 28, on 13 time points
Markers reflecting low-grade inflammation and endothelial activation
Time Frame: Measured at day 28, on 5 time points
Measured at day 28, on 5 time points

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

  • Principal Investigator: Jogchum Plat, Dr., Maastricht University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2010

Primary Completion (Actual)

October 26, 2010

Study Completion (Actual)

February 2, 2012

Study Registration Dates

First Submitted

March 12, 2012

First Submitted That Met QC Criteria

March 19, 2012

First Posted (Estimate)

March 21, 2012

Study Record Updates

Last Update Posted (Actual)

September 6, 2018

Last Update Submitted That Met QC Criteria

September 4, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MEC 09-3-088
  • TOP grant No. 91208006 (Other Grant/Funding Number: ZonMw)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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