Plant Stanols and Gene Expression Profile
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      Plant sterols and stanols are dietary components that are naturally present in plants. Their
      biological function in plants is comparable with these of cholesterol in animals. They are
      structurally related to cholesterol, but are absorbed by enterocytes to a much lesser extent.
      It is generally accepted that they inhibit intestinal cholesterol absorption and consequently
      lower serum low-density lipoprotein (LDL) cholesterol concentrations up to 10% at daily
      intakes of 2.5 g. The exact underlying mechanism of the plant sterol/stanol mediated
      reduction in intestinal cholesterol absorption is still unknown. It has been suggested that
      they lower the activity of sterol uptake transporters like Niemann-Pick C1 like 1 protein
      (NPC1L1) in enterocytes, otherwise several studies indicated that these compounds could
      activate the liver X receptor (LXR) in enterocytes, thereby activating the ABC transporters
      involved in the intestinal cholesterol metabolism, whereas recently suggestions have been
      made that plant sterols and stanols activate transintestinal cholesterol excretion (TICE).
      This is the direct cholesterol secretion from the blood into the intestinal lumen, in which
      the enterocytes play a central role. None of these assumptions have so far been evaluated in
      humans.

      Objective: The major objective of the present study is to examine the acute effects of
      dietary plant stanol esters on the intestinal mucosal gene expression profiles in intestinal
      biopsies in healthy volunteers. The minor objective is to investigate whether semi-long-term
      use (3 weeks) of plant stanol esters have an effect on microbiota composition.
    

Detailed description: 
      lant sterols and stanols are dietary components that are naturally present in plants. Their
      biological function in plants is comparable with these of cholesterol in animals. They are
      structurally related to cholesterol, but are absorbed by enterocytes to a much lesser extent.
      It is generally accepted that they inhibit intestinal cholesterol absorption and consequently
      lower serum low-density lipoprotein (LDL) cholesterol concentrations up to 10% at daily
      intakes of 2.5 g. The exact underlying mechanism of the plant sterol/stanol mediated
      reduction in intestinal cholesterol absorption is still unknown. It has been suggested that
      they lower the activity of sterol uptake transporters like Niemann-Pick C1 like 1 protein
      (NPC1L1) in enterocytes, otherwise several studies indicated that these compounds could
      activate the liver X receptor (LXR) in enterocytes, thereby activating the ABC transporters
      involved in the intestinal cholesterol metabolism, whereas recently suggestions have been
      made that plant sterols and stanols activate transintestinal cholesterol excretion (TICE).
      This is the direct cholesterol secretion from the blood into the intestinal lumen, in which
      the enterocytes play a central role. None of these assumptions have so far been evaluated in
      humans.

      Objective: The major objective of the present study is to examine the acute effects of
      dietary plant stanol esters on the intestinal mucosal gene expression profiles in intestinal
      biopsies in healthy volunteers. The minor objective is to investigate whether semi-long-term
      use (3 weeks) of plant stanol esters have an effect on microbiota composition.
    

Intervention name(s): control margarine; plant stanol-enriched margarine
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects will undergo a postprandial test for 5.5 hours, in which 26.7gram of the control margarine is consumed together with a high-fat milkshake.
Daily consumption of 20 gram of a control margarine (providing daily 3.0 gram of plant stanols), for a period of 3 weeks.; Subjects will undergo a postprandial test for 5.5 hours, in which 26.7gram of the plant stanol-enriched margarine is consumed together with a high-fat milkshake.
Daily consumption of 20 gram of a plant stanol-enriched margarine (providing daily 3.0 gram of plant stanols), for a period of 3 weeks.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Plant stanols; Gene expression profile; Microbiota