Gastric Emptying and Gallbladder Motility Study

This study has been completed.
Sponsor:
Collaborator:
Unilever R&D
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00940849
First received: July 15, 2009
Last updated: February 16, 2011
Last verified: February 2011
  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

Resource links provided by NLM:


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:
    Dietary Supplement: Plant sterol containing drink
    The test products used in the study will be a commercially available PS drink and a ready to eat macaroni meal
    Dietary Supplement: Standard macaroni meal
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Maastricht University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 October 29, 2014