Gastric Emptying and Gallbladder Motility Study

Gastric Emptying of Plant Sterol-containing Mini Drinks in Different Meal Intake Scenarios and Their Effect on Gallbladder Emptying

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.

Study Overview

• Status: Completed
• Conditions: Gastric Emptying
• Intervention / Treatment: Dietary supplement: Plant sterol containing drink; Dietary supplement: Standard macaroni meal

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
GB volume measurement by ultrasonography	September 2009

Secondary Outcome Measures

Outcome Measure	Time Frame
GE rate measurement by 13C stable isotope breath test and plasma paracetamol concentration by clinical chemistry analysis	December 2009

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Unilever R&D
• Investigators: Principal Investigator: Ad Masclee, MD PhD, Maastrich University Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: July 15, 2009
• First Submitted That Met QC Criteria: July 15, 2009
• First Posted (Estimate): July 16, 2009

Study Record Updates

• Last Update Posted (Estimate): November 13, 2014
• Last Update Submitted That Met QC Criteria: November 11, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: MEC 09-2-042