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Plant Stanols and Gene Expression Profile

This study has been completed.
Sponsor:
Collaborator:
Raisio Group
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01574417
First received: March 20, 2012
Last updated: October 24, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Hypercholesterolemia
 Dietary Supplement: control margarine
Dietary Supplement: plant stanol-enriched margarine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of Plant Stanol Esters on Intestinal Mucosal Gene Expression Profiles and Microbiota Composition in Healthy Human Subjects

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • intestinal mucosal gene expression profiles [ Time Frame: Measured at day 8 and day 64. Changes will be calculated between day 8 and day 64. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • microbiota composition [ Time Frame: measured after 3 weeks consumption of controle margarine and the plant stanol-enriched margarine. Changes will be calculated between these 2 interventions. ] [ Designated as safety issue: No ]
  • lipoprotein profile [ Time Frame: measured at baseline and after 3 weeks ] [ Designated as safety issue: No ]
  • plasma glucose concentration [ Time Frame: measured at day 8 and day 64, on 8 time points ] [ Designated as safety issue: No ]
  • plasma plant stanol concentration [ Time Frame: measured at baseline and after 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: March 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Plant stanol-enriched margarine Dietary Supplement: plant stanol-enriched margarine

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.
Placebo Comparator: control margarine Dietary Supplement: control margarine

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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged between 18-60 years
  • BMI between 20-30kg/m2
  • mean serum total cholesterol < 7.8mmol/L

Exclusion Criteria:

  • unstable body weight
  • active cardiovascular diseases
  • gastrointestinal diseases
  • use of cholesterol-lowering drugs
  • use of lipid-lowering therapy
  • abuse of drug or alcohol
  • pregnant or breast-feeding women
  • current smoker
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01574417

Locations
Netherlands
Maastricht University Medical Centre
Maastricht, Limburg, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Raisio Group
Investigators
Principal Investigator: Jogchum Plat, Dr Maastricht University Medical Centre
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01574417     History of Changes
Other Study ID Numbers: METC 12-3-005
Study First Received: March 20, 2012
Last Updated: October 24, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Plant stanols
Gene expression profile
Microbiota

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 16, 2013