ClinicalTrials.gov
ClinicalTrials.gov Menu

Gastric Emptying and Gallbladder Motility Study

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.
ClinicalTrials.gov Identifier: NCT00940849
Recruitment Status : Completed
First Posted : July 16, 2009
Last Update Posted : November 13, 2014
Sponsor:
Collaborator:
Unilever R&D
Information provided by (Responsible Party):
Maastricht University Medical Center

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.


Condition or disease Intervention/treatment Phase
Gastric Emptying Dietary Supplement: Plant sterol containing drink Dietary Supplement: Standard macaroni meal Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
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
Study Start Date : October 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : October 2010

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. GB volume measurement by ultrasonography [ Time Frame: September 2009 ]

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


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

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