Gastric Emptying and Gallbladder Motility Study - Full Text View

Purpose

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.

Condition	Intervention
Gastric Emptying	Dietary Supplement: Plant sterol containing drink Dietary Supplement: Standard macaroni meal

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Basic Science
Official Title:	Gastric Emptying of Plant Sterol-containing Mini Drinks in Different Meal Intake Scenarios and Their Effect on Gallbladder Emptying

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:

GB volume measurement by ultrasonography [ Time Frame: September 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

GE rate measurement by 13C stable isotope breath test and plasma paracetamol concentration by clinical chemistry analysis [ Time Frame: December 2009 ] [ Designated as safety issue: No ]

Estimated Enrollment:	18
Study Start Date:	October 2009
Study Completion Date:	October 2010
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00940849

Locations

Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6200

Sponsors and Collaborators

Maastricht University Medical Center

Unilever R&D

Investigators

Principal Investigator:

Ad Masclee, MD PhD

Maastrich University Medical Center

More Information

No publications provided

Responsible Party:	Prof. Dr. AAM Masclee, Maastricht University Medical Center
ClinicalTrials.gov Identifier:	NCT00940849 History of Changes
Other Study ID Numbers:	MEC 09-2-042
Study First Received:	July 15, 2009
Last Updated:	February 16, 2011
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

ClinicalTrials.gov processed this record on May 19, 2013