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Gastric Emptying and Gallbladder Motility Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00940849
First Posted: July 16, 2009
Last Update Posted: November 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Unilever R&D
Information provided by (Responsible Party):
Maastricht University Medical Center
  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
Intervention Model: Single Group Assignment
Masking: Triple (Participant, 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 ]

Secondary Outcome Measures:
  • GE rate measurement by 13C stable isotope breath test and plasma paracetamol concentration by clinical chemistry analysis [ Time Frame: December 2009 ]

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)
Arms Assigned Interventions
Experimental: 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: 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00940849     History of Changes
Other Study ID Numbers: MEC 09-2-042
First Submitted: July 15, 2009
First Posted: July 16, 2009
Last Update Posted: November 13, 2014
Last Verified: November 2014