NCT00940849

Brief Summary

Background of the study: Plant sterols can play an important role in lowering plasma cholesterol. The extent to which plant sterols can reduce plasma cholesterol levels depends on the intake scenario. We suggest that the difference in these effects depends on gastric emptying and bile secretion. Objective of the study: The aim of this study is to gain insight in the mechanisms that may be involved in the effects of plant sterol drinks on gastric emptying and gallbladder motility. In order to test this, we compare the different effects of the consumption of a plant sterol containing drink prior to, during and after a standardized meal.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2009

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

First Submitted

Initial submission to the registry

July 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 16, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

November 13, 2014

Status Verified

November 1, 2014

Enrollment Period

2 months

First QC Date

July 15, 2009

Last Update Submit

November 11, 2014

Conditions

Gastric Emptying

Outcome Measures

Primary Outcomes (1)

  • GB volume measurement by ultrasonography

    September 2009

Secondary Outcomes (1)

  • GE rate measurement by 13C stable isotope breath test and plasma paracetamol concentration by clinical chemistry analysis

    December 2009

Study Arms (1)

Dietary Supplement: Plant sterol containing drink

EXPERIMENTAL

The test products used in the study will be a commercially available PS drink and a ready to eat macaroni meal

Dietary Supplement: Plant sterol containing drinkDietary Supplement: Standard macaroni meal

Interventions

Plant sterol containing drinkDIETARY_SUPPLEMENT

The test products used in the study will be a commercially available PS drink and a ready to eat macaroni meal

Dietary Supplement: Plant sterol containing drink
Standard macaroni mealDIETARY_SUPPLEMENT

The test products used in the study will be a commercially available PS drink and a ready to eat macaroni meal

Dietary Supplement: Plant sterol containing drink

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Signed informed consent form
  • Sex: male
  • Age: 18-55 years
  • Body Mass Index (BMI): 20-25 kg/m2

You may not qualify if:

  • History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery which might limit participation in or completion of the study protocol.
  • Use of any medication on regular basis.
  • Use of paracetamol prior to treatment (≤ 48 hour).
  • Use of plant sterol/stanol enriched products or supplements 3 months prior to the study.
  • Blood donations less than three months previous to study enrolment.
  • Known hypersensitivity or allergy towards paracetamol.
  • Hyperlipidaemia (TG \> 3 mmol/L and/or tot. chol. \> 8 mmol/L)
  • Corn products prior to treatment (≤ 48 hour)
  • Presence of gallbladder stones.
  • Known allergy for cow milk and/or lactose intolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6200, Netherlands

Location

Related Publications (1)

  • Keszthelyi D, Knol D, Troost FJ, van Avesaat M, Foltz M, Masclee AA. Time of ingestion relative to meal intake determines gastrointestinal responses to a plant sterol-containing yoghurt drink. Eur J Nutr. 2013 Jun;52(4):1417-20. doi: 10.1007/s00394-012-0440-3. Epub 2012 Aug 23.

    PMID: 22915051RESULT

Study Officials

  • Ad Masclee, MD PhD

    Maastrich University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 15, 2009

First Posted

July 16, 2009

Study Start

October 1, 2009

Primary Completion

December 1, 2009

Study Completion

October 1, 2010

Last Updated

November 13, 2014

Record last verified: 2014-11

Locations

NL(1)