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NCT Number: NCT01559428

Phytosterols and Oxyphytosterol Concentrations

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.

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Key information

Conditions

Normocholesterolemic Cardiovascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Centre

Maastricht, Limburg, 6229 ER, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plant sterol-enriched margarine

Dietary 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 stanol-enriched margarine

Dietary 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

control margarine

Dietary 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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Plasma glucose concentration

    Time frame: Measured at day 28, on 13 time points

  4. Markers reflecting low-grade inflammation and endothelial activation

    Time frame: Measured at day 28, on 5 time points

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2012
First posted
Mar 21, 2012
Registry last updated
Sep 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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