NCT01574417

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2012

Shorter than P25 for not_applicable

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

March 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2012

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 10, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

October 25, 2012

Status Verified

October 1, 2012

Enrollment Period

7 months

First QC Date

March 20, 2012

Last Update Submit

October 24, 2012

Conditions

Hypercholesterolemia

Keywords

Plant stanolsGene expression profileMicrobiota

Outcome Measures

Primary Outcomes (1)

  • intestinal mucosal gene expression profiles

    Measured at day 8 and day 64. Changes will be calculated between day 8 and day 64.

Secondary Outcomes (4)

  • microbiota composition

    measured after 3 weeks consumption of controle margarine and the plant stanol-enriched margarine. Changes will be calculated between these 2 interventions.

  • lipoprotein profile

    measured at baseline and after 3 weeks

  • plasma glucose concentration

    measured at day 8 and day 64, on 8 time points

  • plasma plant stanol concentration

    measured at baseline and after 3 weeks

Study Arms (2)

Plant stanol-enriched margarine

EXPERIMENTAL
Dietary Supplement: plant stanol-enriched margarine

control margarine

PLACEBO COMPARATOR
Dietary Supplement: control margarine

Interventions

control margarineDIETARY_SUPPLEMENT

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.

control margarine
plant stanol-enriched margarineDIETARY_SUPPLEMENT

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.

Plant stanol-enriched margarine

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Limburg, Netherlands

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jogchum Plat, Dr

    Maastricht University Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 20, 2012

First Posted

April 10, 2012

Study Start

March 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

October 25, 2012

Record last verified: 2012-10

Locations

NL(1)